On August 10, 2015 BioTime, Inc. (NYSE MKT:BTX) reported financial results for the second quarter ended June 30, 2015 and provided a corporate update (Filing, 8-K, BioTime, AUG 10, 2015, View Source [SID:1234507131]).

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"BioTime’s management team has sharpened its focus on our high priority programs," said Dr. Michael D. West, BioTime’s Chief Executive Officer. "Our strategy for achieving the leadership role in regenerative medicine includes: continuing to advance the ongoing clinical trials of our products that are expected to address large unmet patient needs, collaborating with high-quality corporate partners and leading academic medical institutions, financial de-risking by leveraging various sources of non-dilutive financing, adding experienced biopharma executives to our teams at both BioTime and our subsidiaries, and progressively unlocking shareholder value in our subsidiaries. We continue to make progress with our several clinical programs in cell therapies, cell delivery matrices, and cancer diagnostics."

2015 Highlights

Through the second quarter, BioTime and its subsidiaries have reported the following progress on key products and programs.

Cell Therapies

Cell Cure Neurosciences Ltd.

Cell Cure Neurosciences, Ltd. (Cell Cure Neurosciences) is currently enrolling patients at Hadassah University Medical Center in Jerusalem, Israel, in a clinical Phase I/IIa dose-escalation study evaluating the safety and efficacy of OpRegen for geographic atrophy (GA), the severe stage of the dry form of age-related macular degeneration (dry-AMD). Dry-AMD represents nearly 90% of AMD prevalence and currently has no FDA-approved therapy. The Phase I/IIa clinical trial is designed with four cohorts and allows for interim data readouts.

Cell Cure Neurosciences presented preclinical efficacy data for its lead product candidate, OpRegen at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) in May. The findings demonstrated the product’s potential to preserve vision and retinal structure when transplanted into the leading animal model of retinal disease.
In May, Cell Cure Neurosciences was awarded a grant for 2015 of 6.24 million shekels (approximately $1.61 million) from Israel’s Office of the Chief Scientist (OCS) to help finance the development of OpRegen. The OCS has previously supported Cell Cure Neurosciences, providing grants totaling approximately $8.0 million to date in non-dilutive funding.
Asterias Biotherapeutics, Inc. (NYSE MKT: AST)

Asterias Biotherapeutics, Inc. (Asterias) promoted Edward Wirth, M.D., Ph.D. to Chief Medical Officer.
In June, Asterias announced that the first patient had been dosed at the Atlanta-based Shepherd Center in a Phase I/IIa clinical trial evaluating the activity of escalating amounts of AST-OPC1 (oligodendrocyte progenitor cells) in newly injured patients with sensory and motor complete cervical spinal cord injury (SCI). The Phase I/IIa trial is part of the planned registration program for AST-OPC1, with neurologically complete cervical SCI as the first targeted indication.

Also in June, Asterias announced positive long-term follow-up data from a Phase II clinical trial of AST-VAC1 in patients with acute myelogenous leukemia (AML). The results showed that more than 50% of those who received AST-VAC1 had prolonged relapse-free survival, even patients with high-risk AML, including those over 60 years of age and patients in second remission. The data were presented during an oral presentation at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in May.
Asterias was added to the Russell 3000, Russell Global, and Russell Microcap Indexes on June 26, 2015 as part of Russell Investments’ annual reconstitution of its comprehensive set of U.S. and global equity indexes. The Russell indexes are widely used by investment managers and institutional investors for index funds and they serve as benchmarks for passive and active investment strategies.

During the second quarter, Asterias raised a total of $14.5 million in aggregate gross proceeds through various private and public offerings, as well as receiving $1.1 million from the California Institute of Regenerative Medicine (CIRM) in accordance with a quarterly disbursement schedule under the $14.3 million grant award related to the AST-OPC1 development program. Year-to-date payments from CIRM total $3.3 million in non-dilutive funding.
Cell Delivery Matrices

Earlier this year, BioTime announced the successful treatment of the first patient in the Company’s pivotal clinical trial in Europe of Renevia for HIV-associated lipoatrophy, which was chosen as the clearest regulatory pathway as the first indication. Patient enrollment is ongoing with completion of enrollment in the trial expected by early next year. Renevia, BioTime’s proprietary cell delivery matrix, is specifically designed to facilitate the stable engraftment and proliferation of transplanted cells.
The results of the Renevia trial could ultimately lead to a submission in 2016 for CE Mark approval in Europe for the treatment of HIV-associated facial lipoatrophy. Positive outcomes of this trial could greatly accelerate the potential development of future therapeutics for other lipoatrophy-related conditions, as well as the potential to expand the use of BioTime’s cell delivery matrices for a number of additional cell types.
Cancer Diagnostics Platform

OncoCyte Corporation

William Annett was named Chief Executive Officer of OncoCyte Corporation (OncoCyte) on June 16, 2015. Bill has extensive experience as a CEO of diagnostics companies and as an executive with Genentech and Accenture, among other companies. His deep experience with product commercialization at leading companies is of particular importance as OncoCyte prepares to launch its first liquid biopsy cancer diagnostic test, currently scheduled for 2016.

OncoCyte also reported positive results from its proprietary, non-invasive, liquid biopsies diagnostics at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) for bladder and breast cancer and the American Thoracic Society (ATS) for lung cancer diagnostics.
OncoCyte announced the appointment of Andrew Arno to its Board of Directors on July 15, 2015. Mr. Arno’s depth of experience in the capital markets, as well as advising emerging companies is expected to greatly benefit the company.
Additional Updates

LifeMap Solutions, Inc.

LifeMap Solutions, Inc. (LifeMap Solutions) continues to extend its lead as the premier commercial entity building on the new ResearchKit software framework developed by Apple, Inc. As previously announced in the first quarter, LifeMap Solutions launched the Asthma Health app. Asthma Health serves as the interface for participants in a large-scale medical asthma research study with the Icahn School of Medicine at Mount Sinai. In the second quarter, the Company posted initial user-behavior findings to the official ResearchKit blog; these initial findings showed the app’s user-retention numbers to be comparable to those of top-charting apps like social networks.

In collaboration with the Mount Sinai – National Jewish Health Respiratory Institute, the Company has also developed a clinical-care app that empowers Chronic Obstructive Pulmonary Disease (COPD) patients to manage their condition under the oversight of a physician. This app, COPD Navigator, continues in its pilot program at Mount Sinai. The company has announced that it will build additional clinical-care apps to manage different chronic conditions.

Patents

In the first half of 2015, BioTime was notified of the issuance of 27 new patents that add to over 700 patents and patent applications filed world wide and licensed or owned by the BioTime family of companies in the field of regenerative medicine. The new patents, either issued or licensed to BioTime or certain of its subsidiaries, includes seven U.S. patents, as well as twenty additional patents issued in Europe, Japan, Canada and Singapore.
Financial Results

Revenue

BioTime’s operating revenues are currently generated from research grants, licensing fees and royalties from the sale of Hextend, and advertising from the marketing of the LifeMap Sciences, Inc.’s (LifeMap Sciences) online database products, and from the sale of hydrogels and stem cell products for research.

Total consolidated revenues for the six months ended June 30, 2015, on a consolidated basis, total revenues were $3.3 million, up $1.1 million or 50% from $2.2 million for the same period one year ago. The increase in revenues is primarily attributable to a $0.9 million increase in grant income primarily from Israel’s Office of the Chief Scientist and CIRM.

Expenses

Consolidated operating expenses for the second quarter were $15.2 million, compared to $13.9 million for the same period in 2014. General and administrative (G&A) expenses for the second quarter were $6.2 million, compared to $4.8 million in the second quarter a year ago. The $1.4 million increase is in part a result of increased staffing at Asterias and at LifeMap Solutions.

Operating expenses for the six months ended June 30, 2015 were $29.7 million, compared to expenses of $26.0 million for the same period of 2014. Excluding Asterias’ operating expense of $10.8 million, BioTime’s expenses alone total $18.9 million. The increase in operating expenses is primarily attributable to increase in staffing and increased expenditures in the Asterias, OncoCyte, and LifeMap Solutions product development programs offset in part by a reduction in development expenses in BioTime’s HyStem hydrogel and the OrthoCyte and ReCyte Therapeutics product development programs.

Net Loss

Net loss attributable to BioTime for the three months ended June 30, 2015 was $9.7 million, including deferred income tax benefits of $1.3 million. For the same period in 2014, net loss was $9.5 million, including deferred income tax benefits of $1.5 million. On a per share basis, net loss for the second quarter in 2015 was $0.12 per share, compared to a net loss of $0.16 per share for the same period in 2014.

Net loss attributable to BioTime common shareholders for the six months ended June 30, 2015 was $19.9 million or $0.25 per share, compared to a net loss of $17.6 million or $0.29 per share per share for the same period in 2014. The increase in net loss is primarily attributed to increased expenditures in the Asterias, OncoCyte, and LifeMap Solutions product development programs offset in part by a reduction in development expenses in BioTime’s HyStem hydrogel and the OrthoCyte and ReCyte Therapeutics product development programs. This increase is to some extent offset by the $2.4 million income tax benefit recorded as of June 30, 2015 and $2.9 million in the same period in 2014.

Net losses attributable to BioTime include losses from BioTime majority owned subsidiaries based upon BioTime’s percentage ownership of those subsidiaries.

Balance Sheet and Subsequent Financing Events

Cash and cash equivalents totaled $31.5 million as of June 30, 2015, compared to $29.5 million as of December 31, 2014. The cash on hand as of June 30, 2015 includes $21.2 million held by Asterias and other subsidiaries.

During the six months ended June 30, 2015, BioTime and certain of its subsidiaries raised approximately $24.0 million of additional equity capital and $5.2 million in non-dilutive funding as follows:

Asterias

$2.8 million gross proceeds from the sale of Asterias AST common stock in "at-the-market" transactions;
$5.5 million in aggregate gross proceeds from the public offering and concurrent private placement of Asterias’ common stock;
$11.7 million from the exercise of 5,000,000 outstanding Asterias common share purchase warrants originally issued in June 2014;
$3.3 million in non-dilutive funding from CIRM.
BioTime

$621,000 from the exercise of BioTime options by employees.
Cell Cure Neurosciences

$1.9 million in non-dilutive funding from the OCS.
OncoCyte

$3.3 million from the sale of 3,000,000 of OncoCyte common stock to long-term OncoCyte investors.

(Filing, 10-Q, Halozyme, AUG 10, 2015, View Source [SID:1234507142])

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(Filing, 10-Q, Puma Biotechnology, AUG 10, 2015, View Source [SID:1234507177])

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On August 10, 2015 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the second quarter ended June 30, 2015 (Press release, Celldex Therapeutics, AUG 10, 2015, View Source [SID:1234507132]).

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"Celldex is acutely aware of the significant unmet need for patients with glioblastoma, and we continue to focus considerable efforts on advancing the RINTEGA program," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "At ASCO (Free ASCO Whitepaper) in June, we presented data from the Phase 2 ReACT study, which achieved the primary endpoint of progression-free survival at six months and, most importantly, demonstrated a survival benefit for patients on the RINTEGA arm. We continue to follow these patients and look forward to presenting data on the emerging long-term survival benefit later this year. The Phase 3 ACT IV study continues to progress as planned, and we look forward to the second interim analysis in late 2015/early 2016."

"Our momentum is further supported by ongoing progress in our pipeline. Varlilumab is now in four combination studies, and we anticipate that a fifth study with Roche’s anti-PDL1 antibody will start later this year. We look forward to presenting data from a number of these studies in 2016 and believe these data will define an important role for varlilumab in cancer immunotherapy treatment. Glembatumumab vedotin also continues to actively enroll patients in two trials—the METRIC study in triple negative breast cancer and a study in metastatic melanoma. We are completing preparations that support the opening of METRIC study sites in the EU early next year and remain on track to complete enrollment in 2016. As we continue to advance Celldex towards becoming a fully integrated, commercial-stage biotechnology company, we were pleased to announce the promotion of Dr. Rick Wright to the position of Chief Commercial Officer. In this role, Rick will be responsible for developing a global business strategy and building the infrastructure required to support commercialization of RINTEGA and our cancer immunotherapy pipeline," concluded Marucci.

Program Updates:

RINTEGA ("rindopepimut"; "rindo"; CDX-110), an EGFRvIII(v3)-specific therapeutic vaccine for glioblastoma (GBM)

In June, the independent Data Safety and Monitoring Board (DSMB) recommended continuation of the Phase 3 ACT IV study of RINTEGA (rindopepimut) in patients with newly diagnosed glioblastoma as a result of a prespecified interim analysis assessing safety, futility and efficacy at 50% of events (deaths). The ACT IV study is a randomized, double-blind, placebo controlled study of RINTEGA plus GM-CSF added to standard of care temozolomide in patients with newly diagnosed, surgically resected, EGFRvIII-positive glioblastoma. 745 patients were enrolled into ACT IV to reach the required 374 patients with minimal residual disease (assessed by central review) needed for analysis of the primary overall survival endpoint. All patients, including those with disease that exceed this threshold, will be included in a secondary analysis of overall survival as well as analyses of progression-free survival, safety and tolerability, and quality of life. The second interim analysis is expected to occur in late 2015/early 2016.
Data from the Phase 2 ReACT study in patients with recurrent glioblastoma were presented in an oral session at the 2015 ASCO (Free ASCO Whitepaper) Annual Meeting by David A. Reardon, M.D., Clinical Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute and Associate Professor of Medicine, Harvard Medical School, and the lead investigator of the ReACT study. Patients on the RINTEGA arm experienced a statistically significant overall survival (OS) benefit, and an impressive long-term survival benefit is emerging. The primary endpoint of the study, progression-free survival at six months (PFS6), was met, and a clear advantage was demonstrated across multiple, clinically important endpoints including long-term progression-free survival, objective response rate (ORR) and need for steroids. The Company anticipates that mature overall survival and long-term survival will be presented by year-end at an upcoming medical meeting.

Based on discussions to date with the regulatory authorities about the Phase 2 REACT data, the Company continues to believe the most likely scenario for potential RINTEGA approval filings will be upon receiving data from the ACT IV study, at which time the Company expects that it would file for full approval in both the front-line and recurrent setting. Under the RINTEGA program’s recently awarded Breakthrough Therapy Designation, the Company is actively engaged with the Center for Biologics Evaluation and Research (CBER) to complete all of the required activities associated with the ability to apply for licensure and considerable progress is being made, particularly in the areas of chemistry manufacturing and controls (CMC) and companion diagnostics readiness. The Company will continue to take all the necessary steps to prepare for filing so this process can be completed as expeditiously as possible when ACT IV data become available.

Glembatumumab vedotin ("glemba"; CDX-011), an antibody-drug conjugate targeting gpNMB in multiple cancers

Patient enrollment has accelerated in the Company’s Phase 2b randomized study (METRIC) of glembatumumab vedotin in patients with metastatic triple negative breast cancers that overexpress gpNMB, a molecule associated with poor outcomes for triple negative breast cancer patients and the target of glembatumumab vedotin. Approximately 100 sites are open to enrollment across the United States, Canada and Australia. Trial expansion into the European Union (EU) is underway, and the Company plans to open enrollment in up to 50 sites in the EU in early 2016. Based on current projections, enrollment will be completed in the second half of 2016.

Patient enrollment continues in the Phase 2 study of glembatumumab vedotin in metastatic melanoma. To date, 10 sites are open to enrollment in the United States.

Celldex continues to advance plans to expand the study of glembatumumab vedotin in other cancers in which gpNMB is expressed.
Study design is being finalized for a Phase 2 study in squamous cell lung cancer, and the study is expected to commence in 2H 2015.

Celldex and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (CRADA) under which the NCI will sponsor two studies of glembatumumab vedotin—one in uveal melanoma and one in pediatric osteosarcoma. Protocols for the study are currently being developed.

Varlilumab ("varli"; CDX-1127), a fully human monoclonal agonist antibody that binds and activates CD27, a critical co-stimulatory molecule in the immune activation cascade

The Phase 1/2 study of varlilumab and nivolumab (Opdivo) in adult patients with advanced non-small cell lung cancer, metastatic melanoma, colorectal cancer, ovarian cancer, and head and neck squamous cell carcinoma is actively enrolling patients. This study is being conducted by Celldex under a clinical trial collaboration with Bristol-Myers Squibb Company. The companies are sharing development costs.

In April 2015, Celldex announced that it had entered into a clinical trial collaboration with Roche to evaluate the combination of varlilumab and atezolizumab (anti-PDL1) in a Phase 1/2 study in renal cell carcinoma. Under the terms of this agreement, Roche will provide study drug, and Celldex will be responsible for conducting and funding the study, which is expected to open to enrollment in 2H 2015.

In the second quarter, the Company announced the initiation of two combination studies of varlilumab, both of which are now enrolling patients. Efforts are underway for additional Phase 2 studies of varlilumab, and the Company will provide updates on these studies as they are initiated. Newly initiated studies in the second quarter include:

A Phase 1/2 safety and tolerability study examining the combination of varlilumab and sunitinib (Sutent) in patients with metastatic clear cell renal cell carcinoma (CC-RCC); and,

A Phase 1/2 safety and tolerability study examining the combination of varlilumab and ipilimumab (Yervoy) in patients with Stage III or IV metastatic melanoma. In the Phase 2 portion of the study, patients with tumors that express NY-ESO-1 will also receive Celldex’s CDX-1401.

Celldex presented preclinical data that support varlilumab’s expansion into combination studies with PD-1 inhibitors in a poster session at the 2015 AACR (Free AACR Whitepaper) Annual Meeting in April. Data demonstrated that the combination of varlilumab and anti-PDL1 induces a potent immune-mediated effect that results in important changes in the tumor microenvironment. Most notably, the combination strategy improved the ratio of effector T cells to regulatory T cells, which was accompanied by a reduction in the expression of PD-1 on both effector and regulatory T cells.

The Phase 1b study of varlilumab and ONT-10, Oncothyreon’s therapeutic vaccine targeting the tumor-associated antigen MUC1, continues to actively enroll patients with advanced breast or ovarian cancer. Celldex is providing study drug, and Oncothyreon is conducting the study.

CDX-1401, an antibody-based NY-ESO-1-specific therapeutic vaccine for multiple solid tumors

In the second quarter, Celldex announced the initiation of a Phase 1/2 study examining the combination of varlilumab and ipilimumab (Yervoy) in patients with Stage III or IV metastatic melanoma. This study is currently open to enrollment. In the Phase 2 portion of the study, patients with tumors that express NY-ESO-1 will also receive CDX-1401, an off-the-shelf antibody-based dendritic cell targeted vaccine.

Celldex continues to support several external collaborations, including a National Cancer Institute sponsored Phase 2 study of CDX-1401 and CDX-301 for patients with metastatic melanoma, which is open to enrollment.

CDX-301 (recombinant human Flt3L), a potent hematopoietic cytokine that uniquely expands dendritic cells and hematopoietic stem cells

CDX-301 is being developed as a combination product with other immuno-oncology agents in a number of investigator-sponsored studies.

A pilot study of CDX-301 alone and in combination with Mozobil in hematopoietic stem cell transplantation was initiated in September 2014 and is currently enrolling patients and sibling-matched donors.

Second Quarter and First Six Months 2015 Financial Highlights and 2015 Guidance

Cash position: Cash, cash equivalents and marketable securities as of June 30, 2015 were $334.0 million compared to $359.8 million as of March 31, 2015. The decrease was primarily driven by our second quarter net cash burn of $25.8 million. As of June 30, 2015 Celldex had 98.5 million shares outstanding.

Revenues: Total revenue was $2.2 million in the second quarter of 2015 and $2.7 million for the six months ended June 30, 2015, compared to $0.6 million and $1.0 million for the comparable periods in 2014. The increase in the second quarter of 2015 and the six months ended June 30, 2015 was primarily due to our clinical trial collaboration with Bristol-Myers Squibb and our research and development agreement with Rockefeller University.

R&D Expenses: Research and development (R&D) expenses were $26.5 million in the second quarter of 2015 and $51.6 million for the six months ended June 30, 2015, compared to $24.1 million and $51.2 million for the comparable periods in 2014.

G&A Expenses: General and administrative (G&A) expenses were $8.2 million in the second quarter of 2015 and $14.3 million for the six months ended June 30, 2015, compared to $4.8 million and $9.4 million for the comparable periods in 2014. The increase in G&A expenses was primarily attributable to higher commercial personnel-related expenses as we prepare for potential product launch and a $2.2 million increase year to date in RINTEGA and glembatumumab vedotin commercial planning costs over the $1.9 million spent in the comparable period in 2014.

Net loss: Net loss was $32.4 million, or ($0.33) per share, for the second quarter of 2015 and $62.5 million, or ($0.65) per share, for the six months ended June 30, 2015, compared to a net loss of $28.3 million, or ($0.32) per share and $58.2 million, or ($0.65) per share for the comparable periods in 2014.

Financial guidance: Celldex expects that its cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements through 2017; however, this could be impacted by our clinical data results from the RINTEGA program and their potential impact on our pace of commercial manufacturing and the rate of expansion of our commercial operations.

RINTEGA is a registered trademark of Celldex Therapeutics. Opdivo and Yervoy are registered trademarks of Bristol-Myers Squibb. Sutent is a registered trademark of Pfizer. Mozobil is a registered trademark of sanofi-aventis U.S. LLC.

On August 10, 2015 OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED) reported financial results for the quarter ended June 30, 2015 and provided an update on progress toward 2015 corporate objectives and clinical development milestones, including new data from the Phase 1b clinical trial of demcizumab in non-small cell lung cancer (NSCLC) (Filing, 8-K, OncoMed, AUG 10, 2015, View Source [SID:1234507173]).

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"OncoMed’s second quarter highlighted data from several presentations at the American Academy of Cancer Research and American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meetings, including positive results from our Phase 1b demcizumab and tarextumab clinical trials. The impressive response rate and survival data, as well as safety and biomarker data reported from these studies, set the stage for our four ongoing Phase 2 randomized clinical trials for demcizumab and tarextumab," said OncoMed’s Chairman and Chief Executive Officer, Paul J. Hastings. "Today, we are updating the survival data for the truncated dose demcizumab cohorts of our Phase 1b clinical trial in non-small cell lung cancer. These updated data provide further evidence of prolonged survival for a large subset of patients treated with a demcizumab regimen being utilized in our ongoing DENALI Phase 2 clinical trial in NSCLC."

OncoMed provided updated survival data from 23 patients who received truncated doses of demcizumab plus carboplatin and pemetrexed in the company’s Phase 1b clinical trial in NSCLC. At ASCO (Free ASCO Whitepaper), OncoMed reported Phase 1b clinical trial data in NSCLC for 23 advanced-stage patients who received continuous dosing of demcizumab plus standard-of-care chemotherapy, which showed 43 percent (10 of 23) of patients were alive past two years, demonstrating prolonged survival in this subset of patients. At that time, survival data for 23 patients who received truncated doses of demcizumab plus chemotherapy were showing a similar trend toward improved survival, but the data were less mature. With an additional 3.5 months follow-up for all subjects, no additional deaths have been observed among treated patients. Fifty-two percent (12 of 23) of patients who received truncated doses of demcizumab plus carboplatin and pemetrexed remain alive between 8 and 30 months after treatment and median overall survival has not been reached as of the date of data cut off. These increasingly mature data provide further evidence of prolonged survival in a large subset of demcizumab-treated patients being treated with the regimen being used in OncoMed’s ongoing DENALI Phase 2 clinical trial in NSCLC. OncoMed management will review these updated results today during the planned second quarter 2015 financial results conference call.

"The updated survival data from our Phase 1b clinical trial in first-line advanced stage non-small cell lung cancer reveals impressive long term survival outcomes for the patients treated with truncated dosing demcizumab and chemotherapy," said Jakob Dupont, M.D., Chief Medical Officer. "We are pleased to observe this prolonged tail of the survival curve for patients treated with truncated dosing demcizumab, which is the regimen being utilized in our Phase 2 DENALI clinical trial. The fact that the prolonged tail of the survival curve is observed for patients receiving both continuous and truncated demcizumab dosing is encouraging."

OncoMed Announces Financial Results for the Second Quarter 2015

Recent Business Highlights

• Presented new data from Phase 1b clinical trials of demcizumab (anti-DLL4, OMP-21M18) in patients with first-line advanced non-small cell lung cancer (NSCLC) and pancreatic cancer and for tarextumab (anti-Notch 2/3, OMP-59R5) in small cell lung cancer at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

• Demcizumab administered on a continuous basis in combination with carboplatin and pemetrexed in NSCLC demonstrated survival of greater than two years in a subset of 43 percent (10 of 23) of patients. A retrospective analysis of biomarkers for patients receiving demcizumab with carboplatin and pemetrexed in NSCLC revealed that patients whose tumors showed higher numbers of tumor infiltrating lymphocytes (TILs) prior to treatment appear to be the best responders.

• Demcizumab administered with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) and gemcitabine in first-line advanced pancreatic cancer demonstrated extended progression-free survival, prolonged overall survival and robust anti-tumor activity. The Phase 2 YOSEMITE study is ongoing.

• In 68 patients across the Phase 1b trials, truncated dosing of demcizumab was shown to be safe with no cases of moderate to severe cardiopulmonary toxicity.

• Tarextumab appeared to have dose-dependent and biomarker-driven activity when combined with etoposide and platinum therapy in small cell lung cancer. Patients who received the three-drug combination containing the highest doses of tarextumab and whose tumors tested positive for Notch3 gene expression demonstrated superior anti-tumor response and survival. The phase 2 PINNACLE study is ongoing.

• Initiated dosing of patients on the Phase 1a/1b clinical trial for anti-RSPO3 (OMP-131R10), the first drug in its class to target the R-spondin-LGR pathway, an important cancer stem cell pathway identified by OncoMed researchers.

• Presented seven posters at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting including preclinical research on: the immunomodulatory activities of anti-DLL4 and anti-cancer synergies with anti-PD1; tarextumab’s impact on cancer stem cell frequency; biomarker studies for anti-Notch1 (OMP-OMP-52M51), ipafricept (FZD8-Fc, OMP-54F28) and anti-RSPO3 and evidence of Wnt combination synergies with taxane-based chemotherapeutics.

• Highlighted discovery-stage immuno-oncology pipeline during the company’s first Research and Development Day, including the identification of a T-cell activating agent, GITRL-Fc, and a novel activating receptor for the known checkpoint inhibitor PD-L2, both of which are wholly-owned. Additional novel biologics directed to undisclosed immuno-oncology targets are being developed independently and in collaboration with Celgene.

• Appointed Rick Winningham, Chairman and Chief Executive Officer of Theravance Biopharma, to the Board of Directors.

Second Quarter 2015 Financial Results

Cash, cash equivalents and short-term investments totaled $200.2 million as of June 30, 2015, compared to $213.0 million as of March 31, 2015.

Revenues for the second quarter 2015 totaled $4.7 million, as compared to $6.0 million in the second quarter of 2014. The decrease in revenue over the same period in 2014 was primarily due to a change in the amortization of upfront payment fees under our partnership with Bayer.

Research and development (R&D) expenses for the second quarter 2015 were $22.0 million compared with $18.2 million for the same period in 2014. Increases in R&D expenditures in the three months ended June 30, 2015 were primarily attributable to increased personnel expenses, as well as increased program costs associated with the advancement of OncoMed’s lead clinical-stage product candidates into four randomized Phase 2 trials.

OncoMed Announces Financial Results for the Second Quarter 2015

General and administrative (G&A) expenses for the quarter ended June 30, 2015 were $4.3 million, compared to $3.4 million for the same three-month period in 2014. The increased costs during the second quarter 2015 of $0.8 million were attributable to higher employee-related costs.

Net loss for the second quarter 2015 was $21.6 million ($0.72 per share), compared to $15.6 million ($0.53 per share) for the same three-month period of 2014. The change in net loss for second quarter of 2015 was primarily due to an increase in operational expenses, especially research and development costs.

2015 Full-Year Financial Guidance Reiterated

• 2015 full-year cash expenses are expected to total $100-$110 million, excluding non-cash stock-based compensation, depreciation, and amortization expenses

• OncoMed projects a 2015 year-end cash, cash equivalents and short-term investments balance of over $120 million, before considering the receipt of any potential collaboration milestones

• OncoMed could receive more than $150 million in milestone and option payments from partners during 2015 and 2016