Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the second quarter ended June 30, 2016.
“Celldex continues to build one of the most robust pipelines in immuno-oncology, most recently advancing CDX-014 into the clinic in renal cell carcinoma,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “In collaboration with our investigators, we also presented a significant body of data in the second quarter with eight presentations across both AACR and ASCO that spoke to the broad utility of our product candidates in combination immunotherapy and highlighted a number of the novel targets we are pursuing.”
“We continue to enroll patients to the pivotal METRIC study of glembatumumab vedotin in triple negative breast cancer, with a focus on a number of new sites in Europe that were added over the last quarter and look forward to presenting data from the Phase 2 study of glembatumumab vedotin in metastatic melanoma later this year,” concluded Marucci.
Glembatumumab vedotin (“glemba”; CDX-011), an antibody-drug conjugate (ADC) targeting gpNMB in multiple cancers
- Enrollment continues 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. Enrollment is open across the United States, Canada, and Australia and opened in the European Union in April, with close to 25 sites added in the EU in the second quarter. Additional sites continue to be added to support enrollment completion.
- Patient enrollment is complete, and the primary endpoint has been met in the Phase 2 single-agent study of glembatumumab vedotin in metastatic melanoma (post-progression on checkpoint therapy). The primary endpoint of the study, objective response rate, required a minimum of six responses in the first 52 patients to be deemed successful. Celldex plans to present data from this study at the European Society for Medical Oncology (ESMO) Congress in October 2016. As previously announced, the Company has amended the protocol to add a second cohort of patients to a glembatumumab vedotin and varlilumab combination arm to assess the potential clinical benefit of the combination and to explore varlilumab’s potential biologic and immunologic effect when combined with an ADC. This additional cohort is open to enrollment.
- Celldex is also evaluating glembatumumab vedotin in other cancers in which gpNMB is expressed.
- Celldex has entered into a collaborative relationship with PrECOG, LLC, which represents a research network established by the Eastern Cooperative Oncology Group (ECOG), and PrECOG, LLC is conducting a Phase 1/2 study in squamous cell lung cancer. This study opened to enrollment in April 2016.
- Celldex and the National Cancer Institute (NCI) have entered into a Cooperative Research and Development Agreement (CRADA) under which the NCI is sponsoring two studies of glembatumumab vedotin—one in uveal melanoma and one in pediatric osteosarcoma. Both studies are currently open to enrollment.
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 2 portion of the varlilumab and nivolumab (Opdivo®) study opened to enrollment in April 2016. A protocol amendment was recently finalized to include additional arms evaluating alternate dosing schedules in both renal cell carcinoma and squamous cell head and neck cancer. The non-small cell lung cohort was removed prior to enrolling any patients to accommodate the addition of these new arms. As amended, the overall study size has increased and includes cohorts in colorectal cancer (n=18), ovarian cancer (n=18), head and neck squamous cell carcinoma (n=48), renal cell carcinoma (n=75) and glioblastoma (n=20). The study is being conducted by Celldex under a clinical trial collaboration with Bristol-Myers Squibb Company. The companies are sharing development costs.
Data from the Phase 1 portion (n=36) of the varlilumab and nivolumab study were presented at the American Association for Cancer Research (AACR) Annual Meeting in April. The combination showed acceptable tolerability and safety across all dose levels without any evidence of increased autoimmunity or inappropriate immune activation. Combination therapy led to marked changes in the tumor microenvironment including increased infiltrating CD8+ T cells and increased PD-L1 expression, which have been shown to correlate with a greater magnitude of treatment effect from checkpoint inhibitors in other clinical studies. Additional favorable immune biomarkers, such as increase in inflammatory chemokines and decrease in T regulatory cells, were also noted. In a subset of patients (n=17) on study who had both pre- and post-tumor biopsies available, preliminary evidence also suggested a correlation between biomarker data and stable disease or better in seven of these patients (4 ovarian cancer, 2 colorectal cancer, 1 squamous cell carcinoma of the head and neck).
- Enrollment has been completed in the Phase 1 dose-escalation portion of the Phase 1/2 study of varlilumab and atezolizumab (Tecentriq®; anti-PDL1) in patients with multiple solid tumors. The Company anticipates the Phase 2 portion of the study in renal cell carcinoma will be initiated in the third quarter of this year. This study is being conducted by Celldex under a clinical trial collaboration with Roche. Roche is providing study drug, and Celldex is responsible for conducting and funding the study.
- Additional combination studies of varlilumab continue to enroll patients including:
- 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. The Company anticipates the Phase 1 portion of the study will complete enrollment in the next few months and that the Phase 2 portion of the study will initiate by year-end.
- 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, an NY-ESO-1-antibody fusion protein for immunotherapy.
- As discussed above, a Phase 2 study of varlilumab and glembatumumab vedotin in metastatic melanoma (post-progression on checkpoint therapy).
CDX-1401, an NY-ESO-1-antibody fusion protein for immunotherapy
- As discussed above, a Phase 1/2 study examining the combination of varlilumab and ipilimumab continues to enroll 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 CDX-1401.
- Celldex continues to support several external collaborations, including an NCI sponsored Phase 2 study of CDX-1401 and CDX-301 for patients with metastatic melanoma, which has completed enrollment (n=60 patients; not selected for NY-ESO-1 expression). Initial datafrom this study were presented at the at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting. The data confirmed that CDX-1401 is effective at driving NY-ESO-1 immunity and further demonstrated the value of CDX-301 as a combination agent for enhancing tumor-specific immune response. Based on results to date, plans for additional studies are being considered, including a targeted study in NY-ESO-1 positive disease to determine if these enhanced immune responses can translate to improved clinical outcomes.
- Additionally, Roswell Park Cancer Center is conducting an investigator sponsored study evaluating CDX-1401, poly-ICLC (Hiltonol®) and the IDO1 inhibitor epacadostat (INCB24360) in patients in remission with ovarian, fallopian tube or primary peritoneal cancer. Patients’ tumors must have expressed NY-ESO-1 or the LAGE-1 antigen to be eligible for the study. Celldex is providing CDX-1401 and poly-ICLC in support of this study.
CDX-301 (recombinant human Flt3L), a potent hematopoietic cytokine that uniquely expands the number of dendritic cells to prime the immune system for more robust immune responses to cancer antigens
- As outlined above, data were presented from the Phase 2 study of CDX-1401 and CDX-301 in metastatic melanoma that further demonstrated the value of CDX-301 as a combination agent for enhancing tumor-specific immune response. CDX-301 greatly expanded peripheral blood dendritic cells and was highly effective at increasing cancer antigen specific T cells and antibodies when combined with CDX-1401. These results, which also showed rapid cellular immune responses in a majority of patients, suggests that pre-treatment with CDX-301 could provide a highly applicable, effective immunologic approach.
- CDX-301’s potential activity is also being explored in a Phase 1/2 study of CDX-301 and poly-ICLC in combination with low-dose radiotherapy in patients with low-grade B-cell lymphomas conducted by the Icahn School of Medicine at Mount Sinai.
CDX-014, an antibody-drug conjugate (ADC) targeting the transmembrane protein T-cell immunoglobulin mucin-1 (TIM-1) in renal cell carcinoma
- In July 2016, Celldex announced that enrollment had opened in the Phase 1 dose-escalation portion of the Company’s Phase 1/2 study of CDX-014 in advanced clear cell and papillary renal cell carcinoma (RCC). The Phase 1 study will evaluate cohorts of patients receiving increasing doses of CDX-014 to determine the maximum tolerated dose and a recommended dose for Phase 2 study.
RINTEGA® (“rindopepimut”; “rindo”; CDX-110), an EGFRvIII(v3)-specific therapeutic vaccine for glioblastoma (GBM)
- As previously disclosed, in March, during a pre-planned interim analysis, the independent Data Safety and Monitoring Board (DSMB) recommended discontinuation of the Phase 3 ACT IV study of RINTEGA (rindopepimut) in patients (n=745) with newly diagnosed EGFRvIII-positive glioblastoma. Study closure activities are substantially complete, and Celldex continues to anticipate that the Company will not incur substantial additional costs related to RINTEGA at this time. Celldex is in the process of conducting a thorough review of the data and plans to present the ACT IV results at the Society for Neuro-Oncology Annual Meeting in November of 2016. All patients on the RINTEGA arm of the ACT IV study, prior Phase 2 studies and existing compassionate use recipients have been offered ongoing access to RINTEGA on a compassionate use basis.
Second Quarter and First Six Months 2016 Financial Highlights and Updated 2016 Guidance
Cash position: Cash, cash equivalents and marketable securities as of June 30, 2016 were $220.1 million compared to $254.0 million as of March 31, 2016. The decrease was primarily driven by our second quarter cash used in operating activities of $33.8 million, $5.9 million of which were RINTEGA-related payments. At June 30, 2016, Celldex had 99.4 million shares outstanding.
Revenues: Total revenue was $1.4 million in the second quarter of 2016 and $2.7 million for the six months ended June 30, 2016, compared to $2.2 million and $2.7 million for the comparable periods in 2015. Total revenue was primarily derived from 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 $25.7 million in the second quarter of 2016 and $53.2 million for the six months ended June 30, 2016, compared to $26.5 million and $51.6 million for the comparable periods in 2015.
The decrease in R&D expenses of $0.8 million between the three-month periods was primarily due to lower clinical costs of $3.2 million, offset in part by increased contract manufacturing costs of $0.8 million and personnel costs of $1.6 million, including higher stock-based compensation of $0.8 million.
The increase in R&D expenses of $1.6 million between the six-month periods was primarily due to higher contract manufacturing and other contract service costs and personnel costs, including higher stock-based compensation of $1.3 million, offset by lower clinical costs.
G&A Expenses: General and administrative (G&A) expenses were $7.8 million in the second quarter of 2016 and $17.1 million for the six months ended June 30, 2016, compared to $8.2 million and $14.3 million for the comparable periods in 2015.
The decrease in G&A expenses of $0.4 million between the three-month periods was primarily due to lower commercial planning costs of $1.1 million, partially offset by higher stock-based compensation of $0.7 million.
The $2.8 million increase in G&A expenses between the six-month periods was primarily due to higher stock-based compensation of $1.8 million, facility costs and legal costs.
Net loss: Net loss was $32.0 million, or ($0.32) per share, for the second quarter of 2016 and $66.6 million, or ($0.67) per share, for the six months ended June 30, 2016, compared to a net loss of $32.4 million, or ($0.33) per share and $62.5 million, or ($0.65) per share for the comparable periods in 2015.
Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at June 30, 2016 combined with the anticipated proceeds from future sales of our common stock under our $60 million sales agreement with Cantor Fitzgerald & Co. are sufficient to meet estimated working capital requirements and fund planned operations through 2018. (Original Source)
Shares of Celldex closed today at $4.52, down $0.14 or -3.00%. CLDX has a 1-year high of $22.15 and a 1-year low of $2.96. The stock’s 50-day moving average is $4.56 and its 200-day moving average is $5.04.
On the ratings front, Celldex has been the subject of a number of recent research reports. In a report issued on August 5, Jefferies Co. analyst Biren Amin reiterated a Hold rating on CLDX. Separately, on June 6, Cowen’s Boris Peaker reiterated a Buy rating on the stock and has a price target of $12.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Biren Amin and Boris Peaker have a total average return of 8.2% and 10% respectively. Amin has a success rate of 56% and is ranked #376 out of 4102 analysts, while Peaker has a success rate of 46% and is ranked #351.
Celldex Therapeutics, Inc. engages in the research, development, and manufacture of biopharmaceutical products. Its portfolio includes therapeutic antibodies, antibody drug conjugates, vaccines, and immune system modulators. Its drug candidates include Glembatumumab vedotin, Varlilumab, CDX-1401, CDX-301, and Rintega.