On November 12, 2019 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported financial results for the three and nine months ended September 30, 2019 and highlighted recent corporate updates (Press release, Heron Therapeutics, NOV 12, 2019, View Source [SID1234550939]).

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Recent Corporate Updates

Pain Management Franchise

FDA Acceptance of New Drug Application Resubmission for HTX-011: In October 2019, the U.S. Food and Drug Administration (FDA) accepted Heron’s New Drug Application (NDA) resubmission for HTX-011, an investigational agent for the management of postoperative pain. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of March 26, 2020.
Positive Topline Results from Phase 3b Clinical Study of HTX-011 in Total Knee Arthroplasty: In October 2019, Heron reported positive topline results of a multi-center postoperative pain management study in which 51 patients undergoing total knee arthroplasty (TKA) surgery received HTX-011 together with a scheduled postoperative regimen of generic oral analgesics (acetaminophen and celecoxib). In this study, 75% of patients were discharged from the hospital without a prescription for opioids.
CINV Franchise

CINV 2019 Net Product Sales: For the three months ended September 30, 2019, chemotherapy-induced nausea and vomiting (CINV) franchise net product sales were $42.6 million, up 115% from the same period in 2018, and up 16% from the three months ended June 30, 2019. For the nine months ended September 30, 2019, CINV franchise net product sales were $110.9 million, up 128% from the same period in 2018. Heron is raising its full-year 2019 CINV franchise net product sales guidance from $115–120 million to $135 million.
CINVANTI Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and nine months ended September 30, 2019 were $36.4 million and $97.6 million, respectively, compared to $16.4 million and $32.8 million, respectively, for the same periods in 2018.
SUSTOL Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and nine months ended September 30, 2019 were $6.2 million and $13.3 million, respectively, compared to $3.4 million and $15.8 million for the same periods in 2018.
FDA Approval of Supplemental NDA for CINVANTI: In October 2019, the FDA approved Heron’s supplemental New Drug Application (sNDA) for CINVANTI (aprepitant) injectable emulsion for intravenous (IV) use. The sNDA approval resulted in a CINVANTI label expansion that standardizes the CINVANTI 130 mg single-dose regimen for patients receiving HEC and/or MEC as an injection over 2 minutes or an infusion over 30 minutes, further simplifying dosing and administration and eliminating the need to take oral aprepitant on Days 2 and 3 in patients receiving MEC.
"We are pleased with the advances made during the third quarter of 2019 in both our pain management and CINV franchises, highlighted by the FDA acceptance of our recent NDA resubmission for HTX-011 and strong net product sales for our CINV franchise, even amid the launch of generic fosaprepitant," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics. "We look forward to continuing our commercial momentum with the launch of HTX-011 for postoperative pain management in the second quarter of 2020, pending FDA approval."

Financial Results

Net product sales for the three and nine months ended September 30, 2019 were $42.6 million and $110.9 million, respectively, compared to $19.8 million and $48.6 million, respectively, for the same periods in 2018.

Heron’s net loss for the three and nine months ended September 30, 2019 was $33.6 million and $146.8 million, or $0.42 per share and $1.85 per share, respectively, compared to $38.3 million and $129.3 million, or $0.49 per share and $1.81 per share, respectively, for the same periods in 2018. Net loss for the three and nine months ended September 30, 2019 included non-cash, stock-based compensation expense of $9.7 million and $40.3 million, respectively, compared to $8.1 million and $23.6 million, respectively, for the same periods in 2018.

As of September 30, 2019, Heron had cash, cash equivalents and short-term investments of $256.3 million. Adjusting for net proceeds of $162.2 million from our October 2019 public offering of common stock, Heron had pro-forma cash, cash equivalents and short-term investments of $418.5 million. This compares to $332.4 million in cash, cash equivalents and short-term investments as of December 31, 2018. Net cash used for operating activities for the nine months ended September 30, 2019 was $97.6 million, compared to $158.3 million for the same period in 2018.

About HTX-011 for Postoperative Pain

HTX-011, an investigational agent, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. HTX-011 was granted Fast Track designation from the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted a New Drug Application (NDA) to the FDA for HTX-011 in October of 2018 and received Priority Review designation in December of 2018. A Complete Response Letter (CRL) was received from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to chemistry, manufacturing and controls and non-clinical information. No issues related to clinical efficacy or safety were noted. Heron resubmitted an NDA to the FDA for HTX-011 in September 2019, and the FDA set a PDUFA goal date of March 26, 2020. A Marketing Authorisation Application (MAA) for HTX-011 was validated by the European Medicines Agency (EMA) in March 2019 for review under the Centralised Procedure.

About CINVANTI (aprepitant) injectable emulsion

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of HEC, including high-dose cisplatin, and nausea and vomiting associated with initial and repeat courses of MEC. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute IV infusion or a 2-minute IV injection.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL (granisetron) extended-release injection

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

On November 12, 2019 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported financial results and business highlights for the third quarter ended September 30, 2019 (Press release, Tocagen, NOV 12, 2019, View Source [SID1234550957]).

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"Following the topline readout of our Phase 3 Toca 5 trial, we have been conducting a thorough evaluation of the trial data including analysis of the pre-planned subgroups and molecular data in preparation for our presentation at the upcoming Society for Neuro-Oncology Annual Meeting on November 22," said Marty Duvall, chief executive officer of Tocagen. "These data will inform our next steps with regulatory agencies to evaluate a potential path forward for Toca 511 & Toca FC in recurrent high grade glioma."

Third Quarter 2019 and Recent Highlights

Toca 5 final analysis: On September 12, Tocagen announced the pivotal Toca 5 Phase 3 clinical trial evaluating Toca 511 & Toca FC in patients with recurrent high grade glioma (HGG) missed the primary endpoint of overall survival compared to standard of care treatment and all secondary endpoints.

Toca 5 data to be presented in plenary session at SNO: The Phase 3 Toca 5 trial results will be presented on Friday, November 22, 2019 at 11:50 a.m. MT at the Society for Neuro-Oncology Annual Meeting (SNO) by Timothy Cloughesy, M.D., director of the University of California, Los Angeles, neuro-oncology program. Also, a poster will be presented by NRG Oncology outlining the trial design of the planned Phase 2/3 trial of Toca 511 & Toca FC in patients with newly diagnosed glioblastoma. Copies of the presentations will be available on Tocagen’s website following the presentations.

Reported updated Toca 6 data: In November, Tocagen presented updated data, including immune modulation data, from the Phase 1b trial of Toca 6 in advanced solid tumors at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The preliminary clinical data in 21 patients with a median 4 lines of prior chemotherapy suggested a signal of activity warranting further investigation. The poster can be found here.

Initiated corporate restructuring: On October 3, Tocagen announced a restructuring to extend its cash position and focus resources on the clinical development of Toca 511 & Toca FC.

Third Quarter 2019 Financial Results

License revenue: License revenue was less than $0.1 million for the quarter ended September 30, 2019, compared to $18.0 million for the quarter ended September 30, 2018. The 2018

revenue was related to upfront payments and milestones earned under our license agreement with Apollobio.

Research and Development (R&D) Expenses: R&D expenses were $13.3 million for the quarter ended September 30, 2019, compared to $12.3 million for the quarter ended September 30, 2018. The R&D expenses in both periods were primarily driven by costs to support the Toca 5 trial and manufacturing of drug product. The increase quarter over quarter is primarily due to increased manufacturing related costs offset by reductions in clinical development expenses due to our Toca 5 trial reaching final analysis.

General and Administrative (G&A) Expenses: G&A expenses were $3.8 million for the quarter ended September 30, 2019, compared to $4.3 million for the quarter ended September 30, 2018. The decrease in G&A expenses was primarily due to non-income tax expense of $1.0 million in 2018 offset by increased contracted services to support commercial readiness activities. Based on our clinical trial results, commercial readiness activities have paused.

Net Loss: Net loss was $18.7 million, or $0.78 per common share (basic and diluted), for the quarter ended September 30, 2019, compared to a net loss of $0.4 million, or $0.02 per common share (basic and diluted), for the quarter ended September 30, 2018. The 2019 calculation is based on 23.9 million average common shares outstanding for the third quarter of 2019, compared to 20.0 million average common shares outstanding for the third quarter of 2018.

2019 Nine-Month Results

License revenue: License revenue was less than $0.1 million for the nine months ended September 30, 2019, compared to $18.0 million for the nine months ended September 30, 2018. The 2018 revenue was related to upfront payments and milestones earned under our license agreement with Apollobio.

R&D Expenses: R&D expenses were $37.7 million for the nine months ended September 30, 2019 compared to $35.5 million for the nine months ended September 30, 2018. The increase in R&D expenses for the nine months ended September 30, 2019 primarily reflect increased manufacturing related activities and personnel related costs offset by a reduction in clinical development expenses due to our Toca 5 trial reaching final analysis.

G&A Expenses: G&A expenses were $13.1 million for the nine months ended September 30, 2019 compared to $9.3 million for the nine months ended September 30, 2018, with the increase primarily driven by higher personnel and related costs, including stock-based compensation, due to additional headcount and increased contracted services to support commercial readiness activities. Based on our clinical trial results, commercial readiness activities have paused.

Net Loss: Net loss for the nine months ended September 30, 2019 was $52.9 million, or $2.25 per common share (basic and diluted), compared to a net loss of $29.4 million, or $1.47 per common share (basic and diluted), for the nine months ended September 30, 2018. This calculation is based on 23.5 million average common shares outstanding for the nine months ended September 30, 2019, compared to 19.9 million average shares outstanding for the same period in 2018.

Cash Position

Cash, cash equivalents and marketable securities were $55.3 million at September 30, 2019 compared to $96.1 million at December 31, 2018. In October 2019, Tocagen made a prepayment of $23.3 million toward its loan agreement. This amount was used to prepay $21.5 million of the outstanding principal plus accrued interest and a pro-rated portion of the final payment. After the prepayment, the remaining principal balance is $5.0 million. Due to the corporate restructuring, Tocagen refined its annual cash burn guidance and estimates the total cash used in 2019 to fund operations and capital expenditures will be approximately $60 million (down from approximately $65 million implied in the guidance provided in February 2019).

About Toca 511 & Toca FC

Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511 (vocimagene amiretrorepvec), and an investigational small molecule, Toca FC (flucytosine, extended-release). Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.

On November 12, 2019 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the quarter ended September 30, 2019 and provided a corporate update (Press release, Gossamer Bio, NOV 12, 2019, View Source [SID1234550974]).

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"Since the beginning of the third quarter, we have realized substantial progress advancing our diverse pipeline of four clinical-stage programs," said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer. "Notably, this morning we were pleased to announce that we entered into a clinical trial collaboration with Merck to evaluate KEYTRUDA in combination with GB1275 in selected advanced solid tumors. We believe this combination holds great promise to address a significant unmet need, and we look forward to sharing initial data from our Phase 1/2 study in 2020."

Dr. Gujrathi concluded, "We look forward to continuing the momentum we have built during 2019 into what we expect will be an exciting 2020, with data readouts expected across all of our clinical programs."

Pipeline Updates

GB001: Oral DP2 Antagonist for Asthma and Allergic Disease

Two abstracts supporting GB001 were presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting 2019, held November 7-11 in Houston, Texas, including an analysis of Phase 2 study results previously reported by our partner, Teijin Pharma Ltd. Both posters can now be found in the Posters and Publications section of Gossamer’s website:

Phase 2 study results of DP2-antagonist GB001 on asthma worsening and other asthma control markers

Indicators of Asthma Exacerbation Before Initiation of Biologic Therapy: A Real-world Experience

A poster supporting GB001 was presented at the European Respiratory Society (ERS) International Congress 2019, held September 28 – October 2 in Madrid, Spain. This poster can also be found in the Posters and Publications section of Gossamer’s website.

Markers of Eosinophilic Inflammation are Associated with Response to the DP2 Antagonist GB001 in Patients with Mild Atopic Asthma

Enrollment in the Phase 2b LEDA study in moderate-to-severe eosinophilic asthma remains on track, with an interim analysis expected in the first half of 2020 and topline results expected in the second half of 2020.

Enrollment continues in the Phase 2 TITAN proof-of-concept study in chronic rhinosinusitis, with and without nasal polyps. Topline data from the TITAN study are expected in the second half of 2020.

Gossamer plans to initiate a translational Phase 2 trial in chronic spontaneous urticaria in the first half of 2020 to further characterize the opportunity for DP2 antagonism in this indication.

GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial Hypertension (PAH)

Two abstracts supporting GB002 have been accepted for presentation at the American Heart Association (AHA) Scientific Sessions 2019, being held November 16-18 in Philadelphia, Pennsylvania, both of which will be found in the Posters and Publications section of Gossamer’s website following their presentation:

In Vivo Efficacy of a Novel, Inhaled PDGFRa/b Inhibitor, GB002, In the Rat Monocrotaline and Pneumonectomy Model of Pulmonary Arterial Hypertension

GB002, A Novel Inhaled PDGFR Kinase Inhibitor, Demonstrates Efficacy in The Su5416 Hypoxia Rat Model of Pulmonary Arterial Hypertension (PAH)

Gossamer expects enrollment of its Phase 1b study of GB002 in patients with PAH to begin in the fourth quarter of 2019. Gossamer expects to release initial topline results from the study in the first half of 2020.

Gossamer plans to initiate a Phase 2 study in patients with PAH in the first half of 2020.

GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease

The Phase 1b study in active mild-to-moderate ulcerative colitis remains on track for initial topline results in the first half of 2020.

GB1275: Oral CD11b Modulator for Oncology Indications

Gossamer reported that it has entered into a clinical trial collaboration with Merck to evaluate GB1275 in combination with KEYTRUDA (pembrolizumab) in the KEYNOTE-A36 Phase 1/2 trial. Enrollment in the trial is now underway, with initial data expected in the second half of 2020.

During the third quarter, the U.S. Food and Drug Administration granted orphan drug designation to GB1275 for the treatment of pancreatic cancer.

The design and rationale for the Phase 1/2 first-in-human trial of GB1275 was featured in a trial-in-progress poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting, held November 6-10 in National Harbor, Maryland. This poster can now be found in the Posters and Publications section of Gossamer’s website.

A phase 1/2 study of GB1275, a novel CD11b modulator, as monotherapy and with an anti-PD-1 antibody in specified advanced solid tumors or with chemotherapy in metastatic pancreatic cancer (mPDAC)

Financial Results for Quarter Ended September 30, 2019

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2019, were $446.5 million. The Company expects

current cash, cash equivalents and marketable securities, and access to its debt facility will be sufficient to fund its operating and capital expenditures into the fourth quarter of 2021.

Research and Development (R&D) Expenses: For the quarter ended September 30, 2019, R&D expenses were $40.1 million, including $2.7 million of stock-based compensation, compared to R&D expenses of $18.9 million for the quarter ended September 30, 2018. The increase was primarily due to an increase in expenses for GB001, GB002, GB004 and GB1275.

In-Process Research and Development (IPR&D) Expenses: For the quarter ended September 30, 2019, IPR&D expenses were $0.0 million, compared to $8.3 million for the quarter ended September 30, 2018, which included $7.5 million associated with the acquisition of GB1275.

General and Administrative (G&A) Expenses: For the quarter ended September 30, 2019, G&A expenses were $9.8 million, which included $3.0 million of stock-based compensation. This compared to G&A expenses of $22.9 million for the quarter ended September 30, 2018, which included $18.0 million of stock-based compensation.

Net Loss: For the quarter ended September 30, 2019, net loss was $48.5 million, or a loss of $0.80 per share.

Conference Call and Webcast

Gossamer’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Tuesday, November 12, to discuss its third quarter 2019 financial results and provide a corporate update.

The live audio webcast may be accessed through the Events/Presentations page in the Investors section of the Company’s website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 1981058

Domestic Dial-in Number: (866) 221-1654

International Dial-in Number: (470) 495-9466

Live Webcast: View Source

On November 12, 2019 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported financial results for the third quarter of 2019 and provided an update on regulatory activities related to Vicinium (Press release, Sesen Bio, NOV 12, 2019, View Source [SID1234550990]).

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"The third quarter of 2019 marked a pivotal period for the Company, as we began preparations to transition from a development stage to a commercial stage organization," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We believe Vicinium has demonstrated compelling and clinically meaningful efficacy, and we look forward to submitting these data to the FDA as part of the initiation of our BLA submission in December. This key value inflection point sets up 2020 to be a transformational year for us and we are excited to continue working expeditiously to potentially bring Vicinium to market to help save and improve the lives of patients with NMIBC."

Vicinium Regulatory Pathway Update

Recent positive interactions with the FDA support the Company’s confidence in the regulatory and commercial pathway for Vicinium
On November 4, 2019, the Company met with the FDA for a Type C meeting to discuss the details of a post-marketing confirmatory trial for Vicinium. The Company reached agreement with the FDA that the trial will enroll BCG-refractory patients who have received less-than-adequate BCG. This represents a broader patient population than the BCG-intolerant population originally proposed and it is anticipated that, if Vicinium is approved by the FDA and the post-marketing confirmatory trial is successful, labeling will be expanded to include this additional patient population. This trial is expected to be powered to demonstrate the superior efficacy of Vicinium compared to currently utilized therapies for the primary endpoints, which are expected to include the complete response rate and duration of response in CIS patients. These data, along with the secondary endpoints, which are expected to include a number of quality of life, survival and safety endpoints, are anticipated to position Vicinium for favorable reimbursement with payers.
Key Fourth Quarter 2019 Events

FDA meeting on December 4, 2019 to discuss the submission strategy for CMC Module 3
Anticipated initiation of BLA submission under a Rolling Review in December 2019
Sesen Bio Regulatory Update in December 2019
Third Quarter 2019 Financial Results

Cash Position: Cash and cash equivalents were $57.9 million as of September 30, 2019, compared to $50.4 million as of December 31, 2018.
R&D Expenses: Research and development expenses for the third quarter of 2019 were $6.6 million compared to $3.4 million for the same period in 2018. The increase of $3.2 million was due primarily to costs related to the ongoing technology transfer process as we scale-up for commercial manufacturing and increased regulatory, internal and external staffing costs, partially offset by reduced expenses related to the Phase 3 VISTA trial.
G&A Expenses: General and administrative expenses for the third quarter of 2019 were $3.2 million compared to $3.8 million for the same period in 2018. The decrease was due primarily to lower legal, commercial and internal employee staffing costs, offset by higher professional fees.
Net Loss: Net loss was $13.1 million, or $0.13 per share, for the third quarter of 2019, compared to $14.0 million, or $0.18 per share, for the third quarter of 2018. The decrease was due primarily to a lesser non-cash change in the fair value of contingent consideration, offset by the higher research and development expenses described above.
About the VISTA Clinical Trial
The VISTA trial is an open-label, multicenter, single-arm Phase 3 clinical trial evaluating the efficacy and tolerability of Vicinium as a monotherapy in patients with high-risk, bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC). The primary endpoints of the trial are the complete response rate and the duration of response in patients with carcinoma in situ with or without papillary disease. Patients in the trial received locally administered Vicinium twice a week for six weeks, followed by once-weekly treatment for another six weeks, then treatment every other week for up to two years. To learn more about the Phase 3 VISTA trial, please visit www.clinicaltrials.gov and search the identifier NCT02449239.

About Vicinium
Vicinium, a locally-administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicinium is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicinium promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On November 12, 2019 Exelixis, Inc. (Nasdaq: EXEL) reported that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer, will provide a corporate overview at the Stifel 2019 Healthcare Conference being held next week in New York (Press release, Exelixis, NOV 12, 2019, View Source [SID1234551008]). Exelixis’ presentation has been scheduled for Tuesday, November 19, 2019 at 9:10 AM EST / 6:10 AM PST.

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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

                  Schedule Your 30 min Free Demo!

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 14 days.