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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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.

On November 12, 2019 St. Elizabeth Healthcare reported that has just performed its 10,000th lung screening, a significant and rare milestone only held by a handful of other systems in the country (Press release, St Elizabeth Healthcare, NOV 12, 2019, View Source [SID1234551023]). The system’s estimated rolling 12-month completion rate for eligible patients is over 25%, exceeding the national average of less than 5%, based on 2016 data presented at the 2018 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Kentucky ranks worst in the country for lung cancer diagnosis and death rates, according to 2018 data from the North American Association of Central Cancer Registries reported by the American Cancer Society. Based on the most recent rates published for the current American Joint Committee on Cancer (AJCC) staging system, when lung cancer is diagnosed and treated early (Stage I), the five-year survival rate can exceed 90%. This is all the more important since Kentucky is consistently one of the top two states in smoking rates, according to 2018 CDC data.

"That’s why we have stepped up to solve a problem that’s right here," shared Dr. Doug Flora, executive medical director of oncology services at St. Elizabeth. "We want our patients, their families and the community to do more than recognize Lung Cancer Awareness Month in November—let’s get more area residents screened and save lives."

The lung screening is a low-dose CT scan that has now identified about 100 lung cancers under Stage III. Early detection offers more options, namely allowing St. Elizabeth surgeons and their teams to remove the tumors and often spare lung cancer patients the need for chemotherapy. For patients who are not surgical candidates, the St. Elizabeth radiation oncology team also has excellent means to eradicate the cancer.

"By finding these tumors at an earlier Stage I or II, we are seeing a ‘stage migration’ shift. Pinpointing tumors at lower stages significantly increases chances of survival," said Dr. Michael Gieske, medical director of lung cancer screening at St. Elizabeth. "The screenings are already extending and saving lives."

St. Elizabeth has recruited and developed a large multidisciplinary team to combat lung cancer, led by highly qualified lung cancer surgeons, radiologists, pulmonologists, primary care physicians, nurse navigators and medical and radiation oncologists. Under their direction, a comprehensive lung cancer screening program was built that is among the country’s most robust and successful. Early on St. Elizabeth obtained and continues to maintain certifications as a Screening Center of Excellence and a Diagnostic Imaging Center of Excellence.

Approximately 350 at-risk patients are screened per month at St. Elizabeth, detecting a new lung cancer in about one in every 62 scans. When Dr. Gary Schmitt, radiologist with Radiology Associates of NKY, and Dr. Glen Turner, now retired St. Elizabeth pulmonologist, began the program in late 2013, staff completed seven lung cancer screens total for the year.

"Since the program’s inception, progress and impact are both significant," said Dr. Royce Calhoun, medical director of thoracic surgery at St. Elizabeth. "The screenings give patients and their physicians important information, creating opportunity for early tumor removal when time is of the essence."

St. Elizabeth is investing heavily in building programs and focusing resources on aggressive lung cancer screening and early detection. The St. Elizabeth lung screening program is just one example of being "right here" for the Northern Kentucky community. To learn if you are a candidate for a screening, visit stelizabeth.com/lung.

On November 12, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the exercise of warrants from it’s August 2019 financing (Press release, Oncolytics Biotech, NOV 12, 2019, View Source [SID1234551039]).

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The Company announced the exercise of approximately 1.4 million warrants, at an exercise price of USD $0.90, for net proceeds of approximately USD $1,250,000.

"We are very happy to see these warrants exercised so early," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "This speaks not only to our rapid appreciation as of late, but the belief in Oncolytics’ fundamentals that will continue this momentum through the end of the year and well into 2020. This strengthening of the balance sheet is one more piece in our plan to finance the Company as efficiently as possible through all of it’s catalysts and milestones."

On November 12, 2019 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported financial results for the third quarter ended September 30, 2019, and provided a corporate update (Press release, Cellectar Biosciences, NOV 12, 2019, View Source [SID1234550940]).

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Third Quarter and Recent Corporate Highlights

. Presented data from the DLBCL cohort in the company’s Phase 2 CLOVER-1 study of CLR 131 in relapsed or refractory select B-cell malignancies at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2019. The oral presentation featured data from 6 subjects, who received up to a single 30-minute intravenous (IV) dose of 25mCi/m2 of CLR 131. Data showed durable responses with a mean of 312 days (ongoing) and includes a 33% overall response rate (ORR), a 16.6% complete response rate (CR) and a 50% clinical benefit rate (CBR). CLR 131 had activity in both DLBCL subtypes (germinal center B-cell and activated B-cell) and patients with highly resistant/aggressive cytogenetics (known as "dual hit"). All patients enrolled in the study received an average of 3 prior lines of systemic therapy, 5 of 6 patients were refractory to at least one prior line of therapy.

·Presented a poster entitled: "Phospholipid ether delivery vehicle shows specificity for a broad range of tumor cells and provides a novel and improved approach for targeted therapy," at the Cancer Research UK-AACR Joint Conference on Engineering and Physical Sciences in Oncology. The poster featured data demonstrating that phospholipid ether drug conjugates (PDCs) were capable of delivering small molecule cytotoxins selectively to tumor cells and were well tolerated in animal models.

·Presented data from cohort 6 of its Phase 1 dose escalation study of CLR 131 in relapsed or refractory MM, in a late breaker poster at the 17th International Myeloma Workshop. Data highlighted 4 subjects in cohort 6 who received a fractionated dose of 37.5mCi/m2. Subjects in this cohort achieved a 50% ORR, with two subjects achieving partial responses (PR) and two subjects achieving minimal responses (39% and 48% reduction in M protein). CLR 131 was deemed safe and tolerated in all subjects with cytopenias being the only reported treatment emergent adverse events of grade 3 or higher. The majority (75%) of the subjects had high risk cytogenetics where median bone marrow plasma cell involvement was 25%. Patients’ median age was 72.5 and they averaged 5 prior systemic therapies, with one patient being dual class refractory, one being quad-refractory, and two penta-refractory.

·Received a second FDA Fast Track Designation for CLR 131 for relapsed/refractory DLBCL. CLR 131 is currently being evaluated in patients with select B-cell lymphomas, including MM and DLBCL in the Phase 2 CLOVER-1 clinical study.

·Successfully completed the first cohort of malignant brain tumor patients in the ongoing Phase 1 study of CLR 131 in children and adolescents with select solid tumors, lymphoma, and malignant brain tumors, including relapsed or refractory neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma, and osteosarcoma. The independent Data Monitoring Committee determined the 15mCi/m2 single dose to be safe and tolerated and recommended the company progress to a second cohort utilizing a 30mCi/m2 single dose of CLR 131.

· Received orphan drug designation from the European Commission for CLR 131 in the treatment of multiple myeloma. The designation provides ten years of market exclusivity for the treatment of multiple myeloma.

·Strengthened the management team with the appointment of Dov Elefant, Chief Financial Officer.

"We continue to effectively manage our financial resources to fund our budgeted operations into 2021 while advancing multiple clinical and preclinical programs. The third quarter proved to be highly productive for Cellectar with CLR 131 receiving FDA Fast Track Designation for DLBCL and Orphan Drug Designation for multiple myeloma from the European Commission. In addition, we presented incremental positive data at international scientific conferences," said Jim Caruso, CEO of Cellectar. "We continue to anticipate data from our ongoing clinical studies by the end of this year and in early 2020."

Third Quarter and Nine Months Summary of Financial Results

Cash and Cash Equivalents: As of September 30, 2019, cash and cash equivalents were approximately $13.3 million compared to $13.3 million as of December 31, 2018. The company believes the cash balance is adequate to fund its budgeted operations into the first quarter 2021. Cash used in operating activities was approximately $9.0 million during the nine months ended September 30, 2019 as compared to $8.7 million used during the nine months ended September 30, 2018.

Research and Development Expense: Research and development (R&D) expense for the three months ended September 30, 2019 was $2.7 million compared to $2.0 million in the three months ended September 30, 2018. The cumulative R&D spending for the first nine months of 2019 was $6.8 million as compared to $5.8 million for the first nine months of 2018. The majority of the company’s R&D spend for year-to-date 2019 was dedicated to the start-up costs and support of our pediatric study. Clinical project costs and manufacturing expenses were $2.1 million and $5.0 million for the three and nine months ending September 30, 2019, respectively.

General and Administrative Expense: General and administrative (G&A) expense for the three months ended September 30, 2019 was approximately $1.3 million compared to approximately $1.1 million in the three months ended September 30, 2018. The cumulative G&A spending for the first nine months of 2019 were of $4.0 million as compared to $3.6 million for the first nine months of 2018.

Net Loss: Net loss attributable to common stockholders for the three months ended September 30, 2019 was $(3.9) million, or a loss of $(0.42) per diluted share, compared to a net loss of $(5.3) million, or a loss of $(1.65) per diluted share, in the three months ended September 30, 2018. Net loss attributable to common stockholders for the nine months ended September 30, 2019 was $(10.7) million, or a loss of $(1.51) per diluted share, compared to a net loss of $(11.7) million, or a loss of $(5.29) per diluted share, in the nine months ended September 30, 2018.

About CLR 131

CLR 131 is a small-molecule, targeted Phospholipid Drug Conjugate (PDC) designed to deliver cytotoxic radiation directly to cancer cells, while limiting exposure to healthy cells. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and two Phase 1 dose-escalating clinical studies, one in multiple myeloma and one in pediatric solid tumors and lymphoma. CLR 131 was granted Orphan Drug designation for the treatment of multiple myeloma, and was granted Orphan Drug and Rare Pediatric Disease designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma.