Dynavax Announces Fourth Quarter 2018 and Full Year 2018 Financial Results

On February 26, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported financial results for the fourth quarter and year ended December 31, 2018 (Press release, Dynavax Technologies, FEB 26, 2019, View Source [SID1234533718]).

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"I am proud of our 2018 achievements, particularly the launch of HEPLISAV-B, which enabled us to generate revenue of $3.9 million in the fourth quarter," said Eddie Gray, chief executive officer of Dynavax. "HEPLISAV-B is the only two-dose hepatitis B vaccine, and it consistently protects more than 90% of adult patients. We are confident that it is poised to become the standard of care hepatitis B adult vaccine, and remain firm in our expectation that HEPLISAV-B operations will become profitable by the end of 2019."

Mr. Gray continued. "In immuno-oncology, we are focused on paths to approval where we believe our TLR9 technology has a competitive advantage. SD-101, in combination with pembrolizumab has consistently demonstrated response rates in melanoma and head and neck cancer that are higher than those reported for pembrolizumab alone. We are actively evaluating a number of opportunities, including partnerships, to advance SD-101 into registrational studies, and are committed to being thoughtful and diligent in determining the best path forward to drive value for our shareholders and provide better options for patients."

2018 and Recent Business Highlights

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

Fourth quarter 2018 sales of $3.9 million compared to $1.5 million in the third quarter 2018

More than 1,200 individual customers purchased HEPLISAV-B in 2018

More than 80% of doses sold to date were purchased by repeat customers

592 of the largest targeted customers, which represent more than 36% of the targeted doses, have received P&T committee approval; 354 have progressed to purchase

Purchase contracts have been executed with 3 of the top 10 retail pharmacies

Initial purchases by state and county health departments through the CDC Vaccines for Adults program began in the first quarter of 2019

Immuno-oncology

SD-101

SD-101 adds meaningful clinical benefit to KEYTRUDA (pembrolizumab) therapy.

In November, the company presented encouraging and consistent results from the Phase 1b/2 trial of SD-101 in combination with KEYTRUDA at the ESMO (Free ESMO Whitepaper) 2018 Congress:

In patients with advanced melanoma who are naïve to anti-PD-1 therapy

70% overall response rate (ORR) in the 2-milligram dose cohort

Tumor shrinkage occurred in both injected target lesions and non-injected target lesions; non-injected lesions demonstrated an ORR of 68%, including visceral metastases in the lung and liver

The ORR is identical to that reported at ASCO (Free ASCO Whitepaper) 2018, despite increasing the patient population by more than 50%, from 30 to 47 patients

85% 6-month progression-free survival (PFS) rate

Observed responses in injected lesions and non-injected distant lesions

Responses were independent of baseline PD-L1 expression

In patients with melanoma refractory or resistant to anti-PD-1 therapy

20.7% ORR in 29 patients in the 8-milligram dose cohort

In patients with head and neck squamous cell carcinoma who were naïve to anti-PD-1 therapy

27.3% ORR in 22 patients in the 8-milligram dose cohort

Dynavax has fully enrolled the 2-milligram cohort in patients with melanoma refractory or resistant to anti-PD-1 therapy and in patients with head and neck squamous cell carcinoma who were naïve to anti-PD-1 therapy. Data from these cohorts are expected later this year.

SD-101 and KEYTRUDA are being evaluated in a new randomized, controlled, investigational treatment arm for the ongoing I-SPY 2 TRIAL for neoadjuvant treatment of locally advanced breast cancer.

Adverse events related to SD-101 treatment have been transient, mild to moderate flu-like symptoms.

DV281

DV281 is a TLR9 agonist designed for delivery to lung cancer patients by inhalation.

Dynavax is conducting a Phase 1b/2 clinical trial in subjects with advanced non-small cell lung cancer to investigate the safety and tolerability of DV281 as monotherapy and in combination with OPDIVO (nivolumab) and to identify a recommended dose for the expansion part of the study.

Studies in preclinical animal models of metastatic cancer show that direct delivery of DV281 to tumor-bearing lungs results in induction of interferons and cytokines and infiltration of T cells, responses similar to those observed after intratumoral injection of SD-101.

Dynavax will present a poster (Abstract 8304) from the safety portion of the inhaled DV281 study at the AACR (Free AACR Whitepaper) Annual Meeting. The poster titled "Phase Ib/II, open label, multicenter study of inhaled DV281, a Toll-like receptor 9 agonist, in combination with nivolumab in patients with advanced or metastatic non small cell lung cancer (NSCLC)" will be presented Tuesday, April 2, 2019, from 1 to 5 p.m. ET.

Preclinical Research

Dynavax has multiple immuno-oncology preclinical research programs including a cancer vaccine program and a multi-pronged program to develop TLR7 and TLR8 agonists, both as anti-cancer agents and as vaccine adjuvants. The company is also evaluating additional candidates to leverage the hepatitis B 1018 adjuvant in additional vaccines.

Financial Results

Product Revenue, Net. Dynavax’s first commercial product, HEPLISAV-B, was launched in the first quarter of 2018. Net product revenue for the fourth quarter of 2018 was $3.9 million, compared to $1.5 million in the third quarter of 2018. Net product revenue for the full year 2018 was $6.8 million. Product revenue from sales is recorded at the net sales price, which includes estimates of product returns, chargebacks, discounts and other fees.

Cost of Sales, Product. Cost of sales, product, for the fourth quarter of 2018 was $1.6 million and $10.9 million for the year ended December 31, 2018. Included in cost of sales, product, are inventory reserves and fill, finish and overhead costs for HEPLISAV-B incurred after FDA approval. Also included are costs associated with resuming operations at the manufacturing facility in Düsseldorf after receiving regulatory approval for the pre-filled syringe presentation, which costs previously were included in research and development expense.

R&D Expenses. Research and development expenses for the fourth quarter of 2018 totaled $22.9 million compared to $17.4 for the fourth quarter 2017. Full year 2018 research and development expenses totaled $75.0 million compared to $65.0 million in 2017. The increase

reflects increased compensation and related personnel costs and clinical trial and research expenses related to the ongoing development of SD-101, DV281 and earlier stage oncology programs. Upon approval of pre-filled syringes in the first quarter 2018, costs associated with resuming activities at the manufacturing facility in Düsseldorf were charged to cost of sales, product while costs incurred to manufacture HEPLISAV-B for commercial sale were accounted for as inventory.

SG&A. Selling, general and administrative expenses for the fourth quarter of 2018 totaled $16.4 million compared to $9.3 million for the fourth quarter of 2017. Full year 2018 selling, general and administrative expenses totaled $64.8 million compared to $27.4 million in 2017. The increase in full year 2018 is primarily due to an overall increase in HEPLISAV-B sales, marketing and commercial activities, including full-deployment of a contract sales force, post-marketing studies and consultants for commercial development services.

Net Loss. Net loss for the fourth quarter of 2018 was $40.0 million, or $0.64 per basic and diluted share, compared to a net loss of $27.4 million, or $0.45 per basic and diluted share, for the fourth quarter of 2017. Full year 2018 net loss was $158.9 million, or $2.55 per basic and diluted share, compared to a net loss of $95.2 million, or $1.81 per basic and diluted share for the full year 2017.

Cash Position. Cash, cash equivalents and marketable securities totaled $145.5 million at December 31, 2018, compared to $191.9 million at December 31, 2017. Dynavax plans to borrow $75.0 million under its non-dilutive term loan agreement in the first quarter of 2019 to support commercial efforts and advance its immuno-oncology platform.

Conference Call and Webcast Information

Dynavax will hold a conference call today at 4:30pm ET/1:30pm PT. To access the call, participants must dial (877) 423-9813 in the U.S. or (201) 689-8573 internationally, and use the conference ID 13687416. The live call will be webcast and can be accessed in the "Investors and Media" section of the company’s website at www.dynavax.com. A replay of the webcast will be available for 30 days following the live event.

About Hepatitis B

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. In 2015, new cases of acute hepatitis B increased by more than 20 percent nationally.ii There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.iii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination

for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician’s discretion.iv Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.v

About HEPLISAV-B

HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

For more information about HEPLISAV-B, visit View Source

About SD-101

SD-101, the Company’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 1b/2 study in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.

SELLAS Life Sciences Announces Review of Strategic Alternatives

On February 26, 2019 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported that its Board of Directors is conducting a review of strategic options focusing on maximizing shareholder value (Press release, Sellas Life Sciences, FEB 26, 2019, View Source [SID1234533716]). The Company has engaged Cantor Fitzgerald & Co. to act as its strategic and financial advisor for this process.

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"We are committed to identifying a strategic plan which will enhance shareholder value while allowing for the acceleration of our development programs, so that our novel immunotherapeutics, GPS and NPS, may benefit cancer patients," commented Angelos M. Stergiou, M.D., ScD h.c., President and Chief Executive Officer of SELLAS.

The Company plans to explore a wide range of strategic alternatives that include, among others, a sale of the Company, business combination, merger or reverse merger with another company, strategic investment/financing, or a funded collaboration or partnership which would allow the Company to continue with its current business plan of advancing the clinical development of its lead product candidates, GPS and NPS.

SELLAS recently initiated a Phase 1/2 prospective multi-arm (‘basket’ type), open-label, multi-institutional, U.S.-only clinical study of GPS in combination with Merck & Co., Inc.’s anti-PD-1 therapy, pembrolizumab (Keytruda). The ongoing study is investigating GPS’s effects on the rate of morphological partial to complete response conversion in patients with AML on hypomethylating agents and on the overall response rate in adult patients with ovarian cancer, TNBC, small cell lung cancer, and colorectal cancer with measurable metastatic disease. The study is being led by Drs. Richard Maziarz of Oregon Health and Science University and Roisin O’Cearbhaill of Memorial Sloan Kettering Cancer Center.

The Company also has planned a Phase 3 prospective open-label, randomized, controlled, global, registration-enabling clinical study of GPS monotherapy versus predefined investigator’s choice best available maintenance therapy in adult patients with AML who have achieved their morphological second complete response (with or without complete platelet count recovery; CR2/CR2p) following successful second-line antileukemic therapy. This study is being led by Drs. Hagop Kantarjian of MD Anderson Cancer Center and Gert Ossenkoppele of Amsterdam University Medical Center (VUMC) and the HOVON network.

The Company’s second clinical candidate, NPS, is being developed for TNBC. The Company is currently engaged in discussions with the FDA regarding trial design for a Phase 3 registrational study in TNBC.

The Company has not set a timeline for this process and there can be no assurance that a transaction will be entered into or consummated or, if a transaction is undertaken, as to its terms, structure or timing. The Company does not expect to discuss or disclose further developments regarding the strategic process unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate or required by law.

Keytruda is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA, and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products.

Thermo Fisher Scientific Increases Quarterly Dividend

On February 26, 2019 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that its Board of Directors has authorized a quarterly cash dividend of $0.19 per common share, payable on April 16, 2019, to shareholders of record as of March 15, 2019 (Press release, Thermo Fisher Scientific, FEB 26, 2019, View Source [SID1234533714]). This reflects a 12% increase over the previous dividend payment of $0.17.

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Immunomic Therapeutics to Sponsor and Present at CHCI Health Summit

On February 26, 2019 Immunomic Therapeutics, Inc. reported that its’ Senior Vice President and Co-Founder, Teri Heiland, Ph.D., will participate in the closing plenary on Innovation and Technology in Healthcare at the Congressional Hispanic Caucus Initiative (CHCI) Health Summit on March 14, 2019 at 2:00 pm EST at the Newseum, Knight Conference Center in Washington, DC (Press release, Immunomic Therapeutics, FEB 26, 2019, View Source [SID1234533713]).

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As a sponsor of the CHCI Health Summit, Immunomic Therapeutics is pleased to support the initiatives of the event which include attracting and retaining greater diversity in clinical trials, ensuring equitable health outcomes for the Latino community and considering how the latest technological innovations will support Latino’s health needs. Dr. Heiland will discuss innovation during the closing plenary session and what companies like Immunomic can do to accelerate the development and approval of novel therapies, such as Immunomic’s investigational vaccines, for illnesses that greatly affect Latinos including cancer, allergy and infectious diseases.

For more information, please visit the CHCI summit website at View Source

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

CytomX Therapeutics 2019 Research and Development Day Highlights Clinical Data from Lead Programs and the Broad Potential of Probody™ Therapeutic Platform

On February 26, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported that it will provide a comprehensive update to the company’s clinical-stage pipeline at its 2019 Research and Development Day in New York City (Press release, CytomX Therapeutics, FEB 26, 2019, View Source [SID1234533709]).

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Members of the CytomX management team including Sean McCarthy, D.Phil. president, chief executive officer and chairman; Rachel Humphrey, M.D, chief medical officer and Michael Kavanaugh, M.D., chief scientific officer and head of research and non-clinical development, will lead presentations beginning at 8:00 a.m. EST. Alex Spira, M.D., Ph.D., FACP, Director, Virginia Cancer Specialists Research Institute, Assistant Professor, Johns Hopkins School of Medicine and Medical Director, US Oncology Lung Program will discuss his views on industry trends as well as his experiences as a clinical trial investigator for PROCLAIM-CX-072 and PROCLAIM-CX-2009.

"Our inaugural R&D Day will showcase the tremendous progress CytomX has made in building a pipeline of novel anti-cancer agents with our highly innovative Probody technology platform," said Sean McCarthy, D. Phil, president, chief executive officer and chairman of CytomX Therapeutics. "Several years ago, we set out to reimagine and reinvent therapeutic antibodies so we could make a big difference for cancer patients. The emerging clinical data from our two lead programs support the utility of our Probody technology in achieving this vision and sets us on a path to building the long-term, integrated biotechnology company we have always envisaged."

2019 Research and Development Day Program Highlights

CX-072 Anti-PD-L1 Probody Therapeutic Monotherapy: Continues to Demonstrate Favorable Safety and Durable Anti-Cancer Activity with Encouraging Early Snapshot of Data from Expansion Cohorts in Select Tumor Types at 10 mg/kg:

CX-072 is a wholly owned Probody therapeutic targeting programmed cell death ligand 1 (PD-L1). The Company’s PROCLAIM-CX-072 Monotherapy dose escalation (Parts A and A2) trial is complete without a maximum tolerated dose (MTD) having been reached. Of 24 efficacy evaluable patients with generally weakly immunogenic tumors and treated with doses greater than or equal to 3 mg/kg of CX-072, 12 (50%) demonstrated tumor shrinkage including four partial responses; one confirmed partial response (ongoing), 2 unconfirmed partial responses who are off study and one unconfirmed partial response (ongoing with confirmation scan pending). CX-072 as monotherapy was generally well tolerated in the study.

CytomX selected 10 mg/kg as the dose for its expansion cohorts (Part D). This dose was chosen because it was estimated to achieve a greater than 98% receptor occupancy of PD-L1 expressed on the tumor, demonstrated a favorable safety profile, and demonstrated evidence of biological activity. Pharmacokinetic exposure at the 10 mg/kg dose was sustained above the target level regardless of anti-drug antibody (ADA) status (8 of 13 evaluated patients were positive, 4 were negative, and one had unknown status as of December 2018).

Today, the company will present preliminary data from the Company’s PROCLAIM-CX-072 Part Devaluating CX-072 at 10 mg/kg in patients with triple negative breast cancer (TNBC), undifferentiated pleomorphic sarcoma (UPS), cutaneous squamous cell carcinoma (cSCC) and anal squamous cell carcinoma (SCC) as of a February 6, 2019 data cutoff. Additional cohort expansions in Merkel cell carcinoma, cancers with high tumor mutational burden (hTMB), thymic cancer and small bowel adenocarcinoma are underway. For the TNBC, UPS, SCC and cSCC cohorts, preliminary data from 34 efficacy evaluable patients, showed a preliminary pattern of anti-cancer activity generally consistent with historical data for other PD inhibitors. Of 50 patients evaluable for safety in the four cancers tested as of the data cutoff date, CX-072 as monotherapy was generally well tolerated, with 2 (4%) patients experiencing a Grade 3/4 treatment-related adverse events (TRAE), 2 (4%) patients experiencing a Grade 3/4 immune-related adverse events (irAE) and no discontinuation for treatment-related toxicity. These data compare favorably to historical controls where the rate of Grade 3/4 TRAEs in patients receiving PD-pathway inhibitors and TRAEs leading to discontinuation are 15% and 8%, respectively. Today’s featured speaker, Dr. Spira, will review a case study of a patient from PROCLAIM-CX-072.

CX-072 anti-PD-L1 Probody Therapeutic in Combination with YERVOY (ipilimumab) Continues to Demonstrate Durable Anti-Cancer Activity and a Favorable Safety Profile:

The Company’s PROCLAIM-CX-072 combination dose escalation of CX-072 with ipilimumab (Part B1) is complete with the MTD defined as the combination of 3 mg/kg of ipilimumab and 10 mg/kg of CX-072. Of 19 patients evaluable for efficacy, four (21%) patients experienced confirmed responses as of the February 6, 2019 data cutoff. Three of the four confirmed responses remained on drug as of the data cutoff, including one confirmed complete response (82 weeks) and 2 confirmed partial responses (59 and 64 weeks). Of 27 patients treated with CX-072 in combination with ipilimumab, all with the full ipilimumab dose of 3 mg/kg or above, the combination was generally well tolerated. As of the February 6, 2019 data cutoff, 7 (26%) patients reported a Grade 3/4 TRAE and 3 (11.1%) patients reported a Grade 3/4 irAE. No patients experienced a Grade 3/4 irAE in the 3 mg/kg ipilimumab plus 10 mg/kg of CX-072 arm. These data generally compare favorably with historical controls where the rate of Grade 3/4 treatment-related adverse events in patients receiving a low dose of nivolumab (1 mg/kg) and full dose ipilimumab (3 mg/kg) was reported to be 55%.1

CX-2009, a First-In-Class CD166 Targeting Probody Drug Conjugate, Demonstrates Anti-Cancer Activity Across a Range of Doses and Tumor Types and an Encouraging Safety Profile

CX-2009 is a wholly owned Probody drug conjugate (PDC) that targets CD166, an antigen that is broadly and highly expressed in many types of cancer. CX-2009 is conjugated with the DM4 payload, a clinically-validated toxin licensed from ImmunoGen, Inc.

The Company’s PROCLAIM-CX-2009 dose escalation trial is complete. Patients with breast, castration-resistant prostate, cholangiocarcinoma, endometrial, head and neck, non-small cell lung and ovarian cancers were enrolled with the study comprised of two parts (Part A – unselected patients; Part A2 – patients selected for high CD166 levels). During dose escalation, 76 patients were treated at doses ranging from 0.25 to 10 mg/kg of CX-2009 every 3 weeks. The MTD was not reached. As of the February 6, 2019 data cutoff date, preliminary data from 46 efficacy evaluable patients demonstrated evidence of anti-cancer activity observed at doses of greater than or equal to 4 mg/kg. Tumor shrinkage was observed in 16 (34.8%) patients in multiple tumor types with 5 unconfirmed partial responses (2 each in ovarian and breast cancers and one in head and neck cancer). Of note, comparable levels of anti-cancer activity was observed in patients who were PD-pathway inhibitor naive or resistant, respectively.

CX-2009 was generally well tolerated in the trial with 23 (30.3%) patients experiencing a Grade 3/4 TRAE. The most common adverse event observed was ocular toxicity, an anticipated toxicity associated with the DM4 payload. Other Grade 3/4 TRAEs included liver function test abnormalities, gastrointestinal disorders and nervous system disorders. Currently, dose optimization is underway to further to inform dose selection. Ocular toxicity prophylaxis has been introduced to this dose optimization phase. Dr. Spira, will also review a case study of a patient from PROCLAIM-CX-2009.

"These preliminary data from our ongoing PROCLAIM program provide additional proof of concept for both CX-072 and CX-2009, as well as the Probody platform itself," said Rachel Humphrey, M.D, chief medical officer of CytomX Therapeutics. "CX-072 continues to behave as designed with a safety profile as monotherapy and in combination that has the potential for meaningful differentiation from other PD-pathway inhibitors, while maintaining the expected efficacy for the class. As additional data emerge from the ongoing clinical program, we will be further defining the utility of this agent in the rapidly evolving oncology landscape."

Continued Dr. Humphrey, "Our CX-2009 data shows the ability of our technology to potentially address an entirely new class of highly expressed tumor antigens, with the opportunity to make otherwise undruggable targets available to patients with a wide variety of cancers."

The Next Wave of Innovation

Dr. Michael Kavanaugh will present an update on the broad potential of the Probody platform across a range of therapeutic antibody formats including Probody Drug Conjugates and the application of Probody technology to the emerging modality of T-Cell engaging Bispecific Antibodies (Probody TCBs). Regarding PDCs, Dr. Kavanaugh will describe the company’s strategy for PDC target selection and validation. Regarding Probody TCBs, Dr. Kavanaugh will outline the potential of Probody technology to enable the expansion of the TCB modality to the treatment of solid tumors. Ongoing work aimed at the further optimization of the company’s innovative Probody technology platform will also be presented.

Anticipated 2019 Milestones

PROCLAIM-CX-072 (PD-L1 Probody Therapeutic)

Additional data from monotherapy expansions in selected tumor types at 10 mg/kg arm (Part D).
Initiation of expansion studies of combination with ipilimumab in selected tumor types.
Preliminary data from the combination arm with Zelboraf (vemurafenib) in patients with V600E BRAF-positive melanoma (Part C).
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate)

Additional safety and efficacy data from the monotherapy dose escalation arm (Parts A and A2).
Initiation of an expansion cohort(s) in selected tumor types at a selected dose.
CytomX reported that due to a recent program and portfolio prioritization, the company has decided to indefinitely postpone the clinical trials of CX-188, a PD-1 Probody. The Company may elect to initiate clinical trials of CX-188 in the future.

Bristol-Myers Squibb (BMS) Collaboration Update

As part of our strategic oncology collaboration, BMS has advanced BMS-986249, a CTLA-4 Probody therapeutic, into an ongoing Phase 1/2 clinical trial. BMS has stated that they anticipate preliminary data from this trial in 2019.
In January 2019, BMS provided CytomX notification of termination for three collaboration discovery targets due to portfolio reprioritization. The termination of these targets does not affect other ongoing collaboration discovery and development activities that include BMS-986249.
CytomX 2019 Research and Development Day Webcast

CytomX will host its 2019 Research and Development Day this morning from 8:00 a.m. – 11:30 a.m. ET in New York, NY. The event will be webcast live under the "Investors & News" section of the CytomX website at View Source Please connect to the webcast several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. An archived webcast replay will be available on the Company’s website for 90 days following the event.

FY 2018 Financial Results Conference Call and Webcast

CytomX will report full-year 2018 financial results tomorrow, Wednesday, February 27, 2019, after the close of U.S. markets. Following the announcement, the Company will host a conference call beginning at 5:00 p.m. ET to discuss its results. Participants may access the live audio webcast of the teleconference from the "Investors & News" section of CytomX’s website. An archived replay of the webcast will be available on CytomX’s website until March 6, 2019. The live audio of the conference call can also be accessed by telephone by dialing either (877) 809-6037 (United States and Canada) or (615) 247-0221 (international) and referencing the conference ID 3748238. An archived webcast replay will be available on the Company’s website from February 27, 2019, until March 6, 2019.