On November 8, 2017 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported financial results for the quarter ended September 30, 2017 (Press release, Inovio, NOV 8, 2017, View Source [SID1234521796]).

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Total revenue was $2.6 million for the three months ended September 30, 2017, compared to $12.5 million for the same period in 2016. Total operating expenses were $31.8 million for the current year quarter compared to $32.7 million for the prior year quarter.

The net loss attributable to common stockholders for the quarter ended September 30, 2017 was $34.1 million, or $0.39 per basic share, compared to $20.8 million, or $0.28 per share, for the quarter ended September 30, 2016. The increase in net loss for the quarter resulted primarily from lower revenue recognized from our DARPA Ebola grant and a higher non-cash accounting expense related to the change in fair value of our investment in an affiliated entity.

Revenue

The decrease in revenue was primarily due to lower revenues recognized due to the nearing of successful completion of our DARPA Ebola grant.

Operating Expenses

Research and development expenses for the third quarter of 2017 were $25.5 million compared to $27.0 million for the third quarter of 2016. The decrease in R&D expenses was primarily the result of lower expenses incurred related to our DARPA Ebola grant. General and administrative expenses were $6.3 million for the third quarter of 2017 versus $5.8 million for the third quarter of 2016. The increase in G&A expenses was primarily related to an increase in employee headcount.

Capital Resources

As of September 30, 2017, cash and cash equivalents and short-term investments were $141.9 million compared with $104.8 million as of December 31, 2016. At quarter end the company had 90.3 million shares of common stock outstanding and 99.7 million shares of common stock outstanding on a fully diluted basis.

Inovio’s balance sheet and statement of operations are provided below. The Form 10-Q providing the complete 2017 third quarter financial report can be found at: View Source

Corporate Update

Cancer Immunotherapies

VGX-3100: Cervical Pre-Cancer (Phase 3)

In June, Inovio commenced its phase 3 clinical program to evaluate the efficacy of Inovio’s DNA-based immunotherapy, VGX-3100, to treat cervical dysplasia caused by human papillomavirus (HPV). In a little over three months since trial initiation, Inovio has opened nearly 35 sites, recruiting and dosing patients. The company is on track to open at least 50 sites by the end of the year.

VGX-3100: Vulvar Pre-Cancer (Phase 2)

In April, Inovio commenced a randomized, open-label phase 2 trial to evaluate the efficacy of VGX-3100 in women with high-grade HPV-related vulvar high-grade intraepithelial lesions (HSIL), a disease with a high unmet medical need. The primary endpoint of the study is histologic clearance of high-grade lesions and virologic clearance of the HPV virus in vulvar tissue samples. The study will also evaluate safety and tolerability. There are 10 sites in the U.S. open and recruiting patients.

MEDI0457: HPV-Related Head & Neck Cancer (Phase 1/2)

In May, Inovio announced that MedImmune, AstraZeneca’s global biologics research and development arm, commenced a new clinical trial investigating the combination of MEDI0457 (formerly INO-3112, in-licensed from Inovio), an immunotherapy designed to generate antigen-specific killer T cell responses targeting HPV-associated tumors, and durvalumab (IMFINZI), MedImmune’s PD-L1 checkpoint inhibitor. The combination trial will enroll patients with metastatic HPV-associated squamous cell carcinoma of the head and neck (SCCHN) with persistent or recurrent disease after chemotherapy treatment. This study marks a significant moment for Inovio as it transitions into a late-stage biotechnology company. MedImmune is investigating elevating the response rate of checkpoint inhibitors by using durvalumab in combination with a DNA plasmid vaccine originally licensed from Inovio, which has shown the ability to generate killer T cells.

INO-5401: Metastatic bladder cancer phase 1/2 trial initiated in combination with Genentech’s TECENTRIQ

In October, Inovio initiated a phase 1b/2 immuno-oncology trial to evaluate Genentech/Roche’s atezolizumab (TECENTRIQ) in combination with Inovio’s INO-5401, a T cell activating immunotherapy encoding multiple antigens, and INO-9012, an immune activator encoding IL-12. The multi-center, open-label efficacy trial will be managed by Inovio, and Genentech will supply atezolizumab. The trial is evaluating the safety, immune response and clinical efficacy of the combination therapy in approximately 80 patients with advanced bladder cancer, specifically advanced unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer. The majority of the patients to be enrolled in the trial will have previously received and failed to demonstrate meaningful response to an anti-PD-1 or PD-L1 checkpoint inhibitor alone. Thus, the study will evaluate the potential benefit of a checkpoint inhibitor combined with a DNA-based immunotherapeutic and T cell activator within a bladder cancer patient population with very limited treatment options and poor outcomes.

INO-5401: Glioblastoma phase 1/2 trial initiated in combination with Regeneron’s PD-1 inhibitor

In November, Inovio initiated a phase 1b/2a immuno-oncology trial in patients with newly diagnosed glioblastoma (GBM) designed to evaluate Regeneron’s PD-1 inhibitor, REGN2810, in combination with Inovio’s INO-5401 and INO-9012. The open-label trial of 50 patients will be conducted at approximately 30 U.S. sites, and will evaluate safety, tolerability, immune responses as well as progression-free survival and overall survival. GBM is the most aggressive brain cancer and its prognosis is extremely poor, despite a limited number of new therapies approved over the last 10 years. The median overall survival for patients receiving standard of care therapy is approximately 15 months, and the average five-year survival rate is less than three percent.

INO-5150: Prostate cancer immunotherapy slowed PSA rise in patients with recurrent prostate cancer

An interim data analysis from an ongoing open-label phase 1b study showed that Inovio’s INO-5150 cancer immunotherapy product generated antigen-specific CD8+ killer T cell responses measured in peripheral blood from subjects with biochemically recurrent prostate cancer. In the study, INO-5150 treatment as a monotherapy generated prostate specific antigen (PSA) and prostate specific membrane antigen (PSMA) specific T cell responses in peripheral blood in 60% of the subjects. Moreover, patients with specific CD8+ T cell responses experienced dampening in the rise of PSA and significant increases in PSA Doubling Times (PSADT). PSA is a prostate cancer-associated biomarker, and positive changes in PSA levels could signal INO-5150’s potential positive impact on the treatment of prostate cancer.

dMAb shrunk prostate tumors and protected against antibiotic-resistant bacterial infection in published preclinical studies

Two peer-reviewed scientific papers highlighted the potential impact of dMAb constructs on prostate tumors and in preventing infection from a pneumonia-causing bacteria in preclinical studies. A journal article detailed how Inovio’s dMAb construct against PSMA produced monoclonal antibodies that shrank prostate tumors in a preclinical animal model. This research publication is significant because it is the first to report on the use of Inovio dMAb technology to develop novel monoclonal antibody-based therapies against cancer targets. In another first, Inovio also published results of studies in which its dMAb constructs targeting antibiotic-resistant bacteria protected mice when challenged with a lethal dose of drug-resistant pseudomonas, a pneumonia-causing bacteria.

Infectious Disease Vaccines

Positive Zika vaccine clinical data published in New England Journal of Medicine

In October, Inovio reported positive safety and immune response results from a first-in-man, multi-center phase 1 trial of a vaccine against the Zika virus. The phase 1 trial of Inovio’s DNA-based Zika vaccine (GLS-5700) induced high levels of binding antibodies in 100% of participants. Robust neutralizing antibody and T cell immune response were also observed in vaccinated subjects. These positive results were published in the New England Journal of Medicine in the article, titled "Safety and Immunogenicity of an Anti-Zika Virus DNA Vaccine," authored by Inovio researchers and collaborators. A second phase 1 study, now fully enrolled with 160 participants in Puerto Rico, is designed with a placebo control to explore a potential trend towards clinical efficacy. Inovio is the first company to generate positive human data that clearly supports advancement of DNA technology and its Zika vaccine candidate.

Fully-funded phase 1/2 MERS trial initiated in South Korea

Following approval by the Korean Ministry of Food and Drug Safety, in September, Inovio and its development partner, GeneOne Life Science, initiated a study to evaluate GLS-5300, Inovio’s vaccine against the MERS virus (Middle East Respiratory Syndrome), in a phase 1/2a trial. The International Vaccine Institute (IVI) is fully funding this trial utilizing a $34 million grant from the Samsung Foundation provided to IVI in 2015 to support the development of a MERS vaccine. This phase 1/2a trial represents the second clinical trial of GLS-5300, which remains the first and only MERS vaccine being tested in humans. In the first phase 1 MERS study conducted in the United States, high levels of binding antibodies were measured in 92% of evaluated subjects. Significant antigen-specific cytotoxic T-lymphocyte (CTL) responses were also observed.

Lassa fever vaccine advances

Demonstrating its commitment to global public health, in October, Inovio announced positive results of a preclinical study in which a DNA vaccine provided protection against the Lassa fever virus, which infects about 300,000 people annually. In the study, partnered with U.S. Army scientists and fully funded by a grant from the NIH, Inovio’s DNA vaccine provided 100% protection for non-human primates challenged with a lethal dose of the Lassa fever virus. Inovio’s DNA-based platform is especially well-suited to rapidly respond to viral outbreaks and newly emerging pathogens due to its safety profile, ease and speed of development and manufacturing, as well as the ability to be shipped and stored without a cold-chain environment.

On November 8, 2017 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology Company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that an overview of the Company’s business strategy and commercial and development-stage programs will be given at the Jefferies 2017 London Healthcare Conference being held at the Waldorf Hilton in London. The Company presentation is on Wednesday, November 15th at 4:00 PM GMT (Press release, Spectrum Pharmaceuticals, NOV 8, 2017, View Source [SID1234521765]).

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A live webcast of Spectrum’s presentation will be available at View Source

On November 8, 2017 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of disease-driving genes, reported financial results for the quarter ended September 30, 2017 and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, NOV 8, 2017, View Source [SID1234521766]).

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"Syros made significant progress in the third quarter, driving toward an initial clinical data readout at ASH (Free ASH Whitepaper) from our ongoing Phase 2 clinical trial of SY-1425 as well as adding a combination arm with SY-1425 and an anti-CD38 therapy to the trial, and continuing to execute efficiently on the dose escalation phase of our Phase 1 trial of SY-1365," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We presented key data on both programs, showing favorable PK and evidence of target engagement in patients from the clinical trial of SY-1425, as well as a significant correlation between the biomarker status of patients screened for the trial and differentiation of their cells treated ex vivo with SY-1425, supporting our platform’s ability to identify patients we believe may be most likely to respond to gene control therapies such as SY-1425. For SY-1365, we presented PK and PD data showing substantial anti-tumor activity in preclinical models of multiple cancers using a twice weekly dose consistent with the initial dosing regimen being used in the Phase 1 trial. We are at an exciting time in the company’s evolution, with multiple clinical data readouts for SY-1425 and SY-1365 expected between now and the end of 2018, a rich preclinical pipeline, and a leading gene control platform that we believe will continue to fuel our pipeline and fulfill our mission of improving patients’ lives."

Upcoming Milestones

Syros plans to report initial clinical data from the relapsed or refractory acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (MDS) cohort, as well as the lower-risk transfusion-dependent MDS cohort, in its ongoing Phase 2 clinical trial of SY-1425, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition on Sunday, December 10, 2017. The presentation will include data on evidence of differentiation in patients’ bone marrow and initial assessments of clinical activity and safety of SY-1425 as a single agent. The Phase 2 trial is evaluating the safety and efficacy of SY-1425 as a single agent in four AML and MDS patient populations, as well as in combination with azacitidine in newly diagnosed AML patients who are not suitable candidates for standard chemotherapy. Syros recently amended the protocol of this trial to add a cohort evaluating the safety and efficacy of SY-1425 in combination with an anti-CD38 therapy in patients with relapsed or refractory AML or higher-risk MDS. The Company expects to begin enrolling patients in this cohort in early 2018. All patients enrolled or to be enrolled in the trial are prospectively selected using the Company’s RARA and IRF8 biomarkers.
Syros expects to present additional clinical data from the ongoing Phase 2 trial, including data assessing the safety and efficacy of SY-1425 in combination with azacitidine and with an anti-CD38 antibody, in 2018.
Syros plans to present new preclinical data at ASH (Free ASH Whitepaper) showing significant anti-tumor activity of SY-1365, a first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, in multiple leukemia and lymphoma cell lines, as well as in vivo models of AML. The Company also plans to present preclinical data at ASH (Free ASH Whitepaper) on its identification of a biomarker related to the mitochondrial apoptosis pathway that is predictive of sensitivity to SY-1365 in leukemia cell lines, as well as in vitro data showing synergy with the BCL2 inhibitor venetoclax.
Syros expects to report initial clinical data from its ongoing Phase 1 trial of SY-1365 in patients with advanced solid tumors in 2018.
Recent Platform and Pipeline Highlights

In October 2017, Syros presented preclinical PK and PD data on SY-1365 at the 2017 AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference. The data showed that SY-1365 has a prolonged PD effect and induces sustained tumor regressions in multiple preclinical models using intermittent dosing, supporting the twice weekly dosing regimen currently being used in the Phase 1 trial in patients with advanced solid tumors.
In October 2017, Syros announced a publication co-authored by two of its scientific founders, Nathanael S. Gray, Ph.D., and Richard A. Young, Ph.D., in the peer-reviewed scientific journal Cancer Discovery that highlighted CDK7 inhibition in combination with targeted therapies as a promising new approach for combatting drug resistance. In multiple in vitro and in vivo models of treatment-resistant cancers, CDK7 inhibition enhanced tumor cell killing and impeded the emergence of drug-resistant cell populations when combined with targeted therapies, including MEK, BRAF, EGFR and ALK inhibitors, compared to either a CDK7 inhibitor or the targeted therapy alone.
In October 2017, Syros’ drug discovery research in immuno-oncology was highlighted in an oral presentation at the American College of Surgeons 2017 Clinical Congress. As part of a research collaboration with the Lowy laboratory at the University of California San Diego Moores Cancer Center, Syros scientists identified alterations in regulatory regions of the genome in immune, tumor and stromal cells isolated from pancreatic cancer patient tumors. The goal of the Company’s immuno-oncology program is to discover and develop new drugs with the potential to reactivate the immune system to fight cancer.
In October 2017, Syros presented biomarker data from its ongoing Phase 2 clinical trial of SY-1425 at the European School of Haematology’s 4th International Conference on Acute Myeloid Leukemia "Molecular and Translational": Advances in Biology and Treatment. The data showed that the biomarker status of patients screened for the trial was predictive of myeloid cell differentiation in the patients’ blood samples treated ex vivo with SY-1425, supporting the potential clinical utility of the Company’s biomarkers for patient selection. Data also showed that SY-1425 robustly induced CD38 in an in vivo model of biomarker positive AML. Syros also announced that approximately 40% of the 201 evaluable patients screened for the clinical trial through August were biomarker-positive, including one-third of relapsed or refractory AML and higher-risk MDS patients.
In September 2017, Syros presented PK and PD data from its ongoing Phase 2 clinical trial of SY-1425 at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress. The data showed that the dosing regimen being used in the trial achieves blood levels sufficient to elicit a PD response with evidence of RARα target engagement. Data also showed no significant accumulation or reduction in drug exposure after two weeks of continuous dosing, demonstrating favorable PK properties compared to historical data with ATRA, a non-selective retinoic acid receptor agonist. Syros also presented the design of its ongoing Phase 1 trial for SY-1365 at ESMO (Free ESMO Whitepaper).
In August 2017, Syros announced that the U.S. Food and Drug Administration granted orphan drug designation to SY-1425 for the treatment of AML. Orphan drug designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.
Third Quarter 2017 Financial Results

Cash, cash equivalents and marketable securities as of September 30, 2017 were $81.9 million, compared with $83.6 million on December 31, 2016. The decrease in cash, cash equivalents and marketable securities is primarily due to cash used to fund operations during the nine-months ended September 30, 2017, partially offset by gross proceeds of approximately $35.0 million from Syros’ April 2017 private placement.

For the third quarter of 2017, Syros reported a net loss of $13.8 million, or $0.53 per share, compared to a net loss of $14.2 million, or $0.65 per share, for the same period in 2016. Stock-based compensation included in the net loss was $1.1 million for the third quarter of 2017, compared to $1.7 million for the same period in 2016.

Research and development (R&D) expenses were $10.4 million for the third quarter of 2017, as compared to $11.6 million for the same period in 2016. This decrease was primarily attributable to a $1.0 million milestone payment paid to TMRC Co., Ltd. in September 2016 upon the first dosing of a patient in the Phase 2 clinical trial of SY-1425 for which no comparable payment was made in 2017, a decrease in costs from third parties that conduct research and development and preclinical activities on the Company’s behalf that are primarily due to the completion of GLP toxicology studies for SY-1365 in 2016, and a decrease in stock-based compensation. These decreases were partially offset by increases in discovery expenses. Stock-based compensation included in R&D expenses was $0.4 million for the third quarter of 2017, compared to $1.2 million for the same period in 2016.
General and administrative (G&A) expenses were $3.6 million for the third quarter of 2017, as compared to $2.6 million for the same period in 2016. This increase was primarily attributable to an increase in employee-related costs, including salary, benefits and stock-based compensation. Stock-based compensation included in G&A expenses was $0.7 million for the third quarter of 2017, compared to $0.5 million for the same period in 2016.
Financial Guidance

Syros expects that its operating expenses for 2017 will be approximately $55.0 million. This amount includes approximately $5.0 million in non-cash expenses, primarily consisting of stock-based compensation and depreciation, resulting in an estimated cash burn of approximately $50.0 million for the year.

About Syros Pharmaceuticals

Syros Pharmaceuticals is pioneering the understanding of the non-coding region of the genome to advance a new wave of medicines that control expression of disease-driving genes. Syros has built a proprietary platform that is designed to systematically and efficiently analyze this unexploited region of DNA in human disease tissue to identify and drug novel targets linked to genomically defined patient populations. Because gene expression is fundamental to the function of all cells, Syros’ gene control platform has broad potential to create medicines that achieve profound and durable benefit across a range of diseases. Syros is currently focused on cancer and immune-mediated diseases and is advancing a growing pipeline of gene control medicines. Syros’ lead drug candidates are SY-1425, a selective RARα agonist in a Phase 2 clinical trial for genomically defined subsets of patients with acute myeloid leukemia and myelodysplastic syndrome, and SY-1365, a selective CDK7 inhibitor in a Phase 1 clinical trial for patients with advanced solid tumors, including transcriptionally dependent cancers such as triple negative breast, small cell lung and ovarian cancers. Led by a team with deep experience in drug discovery, development and commercialization, Syros is located in Cambridge, Mass.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the reporting of initial clinical data from the ongoing Phase 2 clinical trial of SY-1425 at the ASH (Free ASH Whitepaper) Annual Meeting; the presentation of additional clinical data on SY-1425 and initial clinical data on SY-1365; the percentage of AML and MDS patients who have the RARA or IRF8 biomarker; the benefits of CDK7 inhibition; the ability to discover and develop drugs in the immuno-oncology field that can reactivate the immune system; anticipated operating expenses and cash burn for the year ended December 31, 2017; and the benefits of Syros’ gene control platform. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Moreover, there can be no assurance that PK and PD data and ex vivo differentiation data generated to date in the ongoing Phase 2 clinical trial of SY-1425 are predictive of the ability of such trial to meet any of its endpoints. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including Syros’ ability to: advance the development of its programs, including SY-1425 and SY-1365, under the timelines it projects in current and future clinical trials; demonstrate in any current and future clinical trials the requisite safety, efficacy and combinability of its drug candidates; replicate scientific and non-clinical data in clinical trials; successfully develop a companion diagnostic test to identify patients with the RARA and IRF8 biomarkers; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; obtain and maintain necessary regulatory approvals; identify, enter into and maintain collaboration agreements with third parties; manage competition; manage expenses; raise the substantial additional capital needed to achieve its business objectives; attract and retain qualified personnel; and successfully execute on its business strategies; risks described under the caption "Risk Factors" in Syros’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, which is on file with the Securities and Exchange Commission; and risks described in other filings that Syros makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Syros expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise.

Sierra Oncology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Sierra Oncology, 2017, NOV 8, 2017, View Source [SID1234521733]).

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Eagle Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Eagle Pharmaceuticals, 2017, NOV 8, 2017, View Source [SID1234521777]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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