On November 8, 2021 Delcath Systems, Inc. (Nasdaq: DCTH ), an interventional oncology company focused on the treatment of rare primary and metastatic cancers of the liver, reported it will participate in an upcoming virtual investor conference (Press release, Delcath Systems, NOV 8, 2021, View Source [SID1234595227]):

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Canaccord Virtual MedTech, Diagnostics and Digital Health & Services Forum
Thursday, November 18, 2021: 1×1 meetings only
To learn more or to schedule a one-on-one meeting with management, please contact your conference representative or [email protected].

On October 8, 2021 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported financial results for the third quarter ending September 30, 2021 and provided a corporate update (Press release, VBI Vaccines, NOV 8, 2021, View Source [SID1234594682]).

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Jeff Baxter, VBI’s President and CEO commented: "The third quarter of 2021 was a notably busy and productive time as we support the ongoing regulatory reviews of our prophylactic 3-antigen HBV vaccine candidate, prepare for the potential launch of this candidate in the U.S., Europe, and Canada, and advance both our immunotherapeutic vaccine candidates against GBM and chronic HBV, as well as our coronavirus pipeline, with the objective of creating vaccines that provide long-term breadth of protection with good safety and tolerability profiles. We look forward to sharing data and updates from the various milestones expected over the next six months across our portfolio. The public health space is constantly evolving, evidenced by the renewed focus on prevention of HBV with the recently revised adult vaccination guidelines, plus the mutational evolution of COVID-19 with new and emerging variants. We are working hard to address significant and relevant unmet medical and public health needs, we believe this dedication and focus on successfully achieving these fundamentals will drive shareholder value."

Recent Accomplishments and Key Anticipated Upcoming Milestones

Hepatitis B (HBV)

3-Antigen HBV Prophylactic Vaccine Candidate

Commercial preparations are ongoing and continue to ramp-up in anticipation of potential regulatory approvals
November 3, 2021: the CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously voted to change the adult recommendations for HBV vaccination from risk based in all ages to a universal recommendation for adults age 19-59, keeping risk-based recommendations for adults age 60+
November 30, 2021: U.S. Prescription Drug User Fee Act (PDUFA) target action date set by U.S. Food and Drug Administration (FDA)
European Medicines Agency (EMA) regulatory review ongoing
Submissions to United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada are in process and are expected to complete in 2022
VBI-2601 (BRII-179) : HBV Immunotherapeutic Candidate

H2 2022: Top-line interim clinical data expected from Phase 2 combination study of VBI-2601 (BRII-179) and BRII-835 (VIR-2218), Vir Biotechnology’s investigational HBV-targeting siRNA; study conducted by partner, Brii Biosciences (Brii Bio)
COVID-19 & Coronaviruses

VBI-2900 : eVLP Coronavirus Vaccine Program

September 2021 : Initiation of Phase 1b study of VBI-2905, VBI’s eVLP vaccine candidate targeting the Beta variant, as both a single-dose booster in adults previously vaccinated with a full course of messenger RNA (mRNA) vaccine, and as a two-dose regimen in unvaccinated adults
Q1 2022 : Initial data expected from one-dose booster study arm, in previously vaccinated adults, in ongoing Phase 1b study
Mid-year 2022 : Expected initiation of the first clinical study of VBI’s trivalent pan-coronavirus vaccine candidate, VBI-2901, designed to increase the breadth of immunity against emerging COVID-19 variants and betacoronviruses
Glioblastoma (GBM)

VBI-1901: Cancer Vaccine Immunotherapeutic Candidate

Based on data seen to-date, we anticipate assessing VBI-1901 in randomized, controlled clinical studies in both primary and recurrent GBM patients as part of the next phase of development
Q1 2022 : Expected initiation of enrollment of expanded number of patients in ongoing study in recurrent GBM, subject to discussions with FDA, increasing study size and adding a control arm to support the potential for accelerated approval based on tumor response data and improvement in overall survival
Mid-year 2022 : Expected initiation of a randomized, controlled clinical study with registration potential in primary GBM patients, subject to discussions with FDA
Recent Publications

May 2021: The Lancet Infectious Diseases publication of data from PROTECT – Phase 3 immunogenicity and safety study assessing VBI’s 3-antigen HBV vaccine candidate compared to Engerix-B in adults age 18 and older. Link to publication can be found here.
June 2021: Vaccine publication of data from a Phase 3 immunogenicity and safety study, conducted in Vietnam and completed in 2007, assessing VBI’s 3-antigen HBV vaccine candidate in healthy Asian adults. Link to publication can be found here.
July 2021: Vaccine publication of data from VBI-2902a preclinical and challenge COVID-19 studies. Link to publication can be found here.
September 2021: JHEP Reports, an open access companion title to Journal of Hepatology, publication of data from the recently completed Phase 1a/2b study of VBI-2601 (BRII-179) in adults with chronic HBV. Link to publication can be found here.
September 2021: bioRxiv publication of preclinical and challenge COVID-19 data from VBI-2902, VBI-2905, and VBI-2901 demonstrating broadened immunity against COVID-19 variants. Link to publication can be found here.
October 2021: The Journal of the American Medical Association Network Open publication of data from CONSTANT – Phase 3 lot-to-lot consistency and immunogenicity study assessing VBI’s 3-antigen HBV vaccine candidate in adults age 18-45. Link to publication can be found here.
Third Quarter 2021 Financial Results

Cash Position: VBI ended the third quarter of 2021 with $137.5 million in cash, cash equivalents, and short-term investments compared with $93.8 million as of December 31, 2020.
Net Cash Used in Operating Activities: Net cash used in operating activities for the nine months ended September 30, 2021 was $21.4 million, compared to $30.6 million for the same period in 2020. The decrease in cash outflows is largely a result of the change in operating working capital, notably the cash received in advance from the CEPI funding agreement, offset by an increase in net loss.
Cash Used for Purchase of Property and Equipment: Cash used for the purchase of property and equipment was $1.4 million for the nine months ended September 30, 2021, compared to $0.5 million for the same period in 2020. The increase is a result of routine purchases of property and equipment at our manufacturing facility in Rehovot, Israel.
Revenue: Revenue in the third quarter of 2021 was $0.1 million, compared to $0.3 million for the same period in 2020. The decrease in revenues was due to a decrease in R&D services revenue as part of the collaboration with Brii Bio. Fewer manufacturing and non-clinical research services were done in the three months ending September 30, 2021 compared to the three months ending September 30, 2020.
Cost of Revenues: Cost of revenues was $2.5 million in the third quarter of 2021 as compared to $2.1 million for the same period in 2020. The increase in the cost of revenues was due to increased outsourced testing costs and inventory-related costs incurred in the three months ending September 30, 2021 compared to the same period in 2020.
Research and Development (R&D): R&D expenses for the third quarter of 2021 were $3.0 million compared to $4.5 million in the third quarter of 2020. The decrease was a result of the government grants and funding arrangements, offset by an increase in the costs related to our coronavirus vaccine program, including the Phase 1a and Phase 1b portions of VBI-2902 and VBI-2905, respectively, and development and manufacturing of VBI-2905. The increase was also due to an increase in R&D expenses related to the development of our other vaccine candidates.
General and Administrative (G&A): G&A expenses were $9.7 million for the third quarter of 2021, compared to $5.6 million for the same period in 2020. The increase was a result of the increased commercialization preparation activities related to the 3-antigen prophylactic HBV vaccine candidate in anticipation of potential regulatory approvals, in addition to increased insurance and labor costs.
Net Loss: Net Loss and net loss per share for the third quarter of 2021 were $15.8 million and $0.06, respectively, compared to a net loss of $13.0 million and a net loss per share of $0.06 for the third quarter of 2020.

On November 8, 2021 Boston Scientific Corporation (NYSE: BSX) reported that it will participate in two upcoming investor conferences (Press release, Boston Scientific, NOV 8, 2021, View Source [SID1234594710]).

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On November 15, 2021, Dan Brennan, executive vice president and chief financial officer, and Lauren Tengler, vice president, Investor Relations, will participate in a 30-minute question-and-answer session with the host analyst at the virtual 2021 Stifel Healthcare Conference. The session will begin at approximately 8:00 a.m. EST.

On December 1, 2021, Dave Pierce, executive vice president and president, MedSurg & Endoscopy; Dr. Brian Dunkin, chief medical officer, Endoscopy; and Lauren Tengler will participate in a 45-minute question-and-answer session with the host analyst for the 2021 virtual Evercore ISI HealthCONx Conference. The session will begin at approximately 8:00 a.m. EST.

A live webcast and replay of the webcast for each event will be accessible at investors.bostonscientific.com. The replay will be available approximately one hour following the completion of each event.

On November 8, 2021 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that management will participate in a fireside chat at the Stifel 2021 Virtual Healthcare Conference on Monday, November 15, 2021 at 2:00 p.m. EST (Press release, IGM Biosciences, NOV 8, 2021, View Source [SID1234594726]).

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On November 8, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported operating results for the third quarter ended September 30, 2021 (Press release, Sesen Bio, NOV 8, 2021, View Source [SID1234594743]). During the quarter, the Company continued to work on its path forward to address chemistry, manufacturing, and controls (CMC) and clinical issues identified by the US Food & Drug Administration (FDA) in its Complete Response Letter (CRL) regarding the Company’s Biologics License Application (BLA) for the Company’s lead program, Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

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"Our team is making progress in advancing our dialogue with the FDA as we work toward potential resolution of the issues raised in the CRL for Vicineum, as demonstrated by our recent CMC Type A Meeting with the agency," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We remain dedicated to saving and improving the lives of patients, and we look forward to continuing to work collaboratively with the FDA in our upcoming Clinical Type A Meeting, expected later this year, to carry our mission into the next stage of the regulatory process and beyond."

Regulatory Update

US:

On August 13, 2021, Sesen Bio announced that it had received a CRL from the FDA regarding its BLA for the Company’s lead program, Vicineum for the treatment of BCG-unresponsive NMIBC. The FDA determined that it could not approve the BLA for Vicineum in its present form and provided recommendations specific to additional clinical/statistical data and analyses, in addition to CMC issues pertaining to a recent pre-approval inspection and product quality.
On October 29, 2021, Sesen Bio participated in a productive CMC Type A Meeting with the FDA (CMC Type A Meeting). The purpose of the meeting was to discuss questions related to CMC raised in the CRL. During the meeting, the Company and the FDA reviewed issues related to CMC to be further discussed during the review of the BLA for Vicineum upon potential resubmission. Key takeaways from the meeting include:
The FDA confirmed that Vicineum manufactured using the proposed commercial process is comparable to Vicineum used in prior clinical trials.
The FDA confirmed that Sesen Bio can utilize Vicineum manufactured during process validation for any potential future clinical trials needed to address issues raised in the CRL, and that these potential trials can proceed while addressing CMC issues.
The Company believes it has a clear understanding of the path forward regarding CMC for resubmission of the BLA.
Sesen Bio is preparing for a separate Type A Meeting to discuss the recommendations specific to additional clinical/statistical data and analyses that the FDA raised in the CRL (Clinical Type A Meeting), which the Company expects to occur later this year. As previously disclosed, the Company anticipates needing to conduct an additional clinical trial with 90-100 patients, and will provide further guidance after the Clinical Type A Meeting.

The Company intends to use the information from the CMC Type A Meeting and the Clinical Type A Meeting to synchronize the regulatory reviews of Vicineum for the treatment of BCG-unresponsive NMIBC in the US and the European Union.

European Union:

On August 20, 2021, Sesen Bio withdrew its marketing authorization application (MAA) to the European Medicines Agency (EMA) for Vysyneum1 for the treatment of BCG-unresponsive NMIBC. Given that certain components in the EMA’s review are interrelated with elements of the FDA’s decision to issue a CRL for Vicineum, the Company decided to pause its plans to pursue regulatory approval of Vysyneum in the European Union until there is more clarity from the FDA on next steps in the United States.
Other Business Updates

On August 30, 2021, Sesen Bio approved a restructuring plan to reduce operating expenses, to better align its workforce with the needs of its business following receipt of the CRL from the FDA for Vicineum, and to better position the Company to execute on next steps as they are determined. The Company expects the plan to decrease its annual cash costs by approximately $5.7 million.
The Company also implemented a program designed to retain employees as the Company continues to work toward the potential resolution of the issues detailed in the CRL. This retention program applies to all current employees except for the Chief Executive Officer.
Third Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and restricted cash were $175.3 million as of September 30, 2021, compared to $55.4 million as of December 31, 2020.
R&D Expenses: Research and development expenses for the third quarter of 2021 were $5.0 million compared to $10.2 million for the same period in 2020. The decrease of $5.2 million was primarily due to lower costs associated with technology transfer and manufacturing ($6.3 million), partially offset by increased license fees related to a milestone payment to the University of Zurich triggered by the completion of the BLA review by the FDA ($0.5 million), regulatory fees triggered by withdrawal of the Company’s MAA to the EMA for Vysyneum ($0.3 million), and regulatory consultant fees ($0.2 million).
G&A Expenses: General and administrative expenses for the third quarter of 2021 were $8.7 million compared to $4.1 million for the same period in 2020. The increase of $4.6 million was due to increases in sales and marketing expense for Vicineum pre-commercial launch planning ($2.4 million), employee-related compensation driven by increased headcount as part of the commercial build ($1.3 million), and professional fees for accounting services ($0.2 million). The majority of these expenses were incurred prior to receipt of the CRL in August 2021. Additionally, an increase in legal fees was driven primarily by legal proceedings and the on-going independent review related to Vicineum ($0.9 million). Such increase was partially offset by certain other decreases in G&A expenses, none of which were individually material ($0.2 million).
Restructuring Charges: Restructuring charges for the third quarter of 2021 were $5.5 million, which were due to one-time costs of approximately $2.7 million associated with the termination of certain contracts, and severance and other employee-related costs of approximately $2.8 million.
Non-Cash Related Expenses:
Intangibles impairment charge for the third quarter of 2021 was $31.7 million. In light of the CRL, the Company performed an interim impairment test for In-Process Research and Development (IPR&D) assets, which resulted in the decrease in fair value of Vicineum’s US rights.
The change in fair value of contingent consideration was a decrease of $114.0 million compared to an increase of $18.4 million for the same period in 2020. This was primarily due to management’s assessment of a lower probability of regulatory success and a refinement of timelines given the CRL.
Income Tax Benefit (Provision): Benefit from income tax was $8.6 million compared to $1.1 million tax expense for the same period in 2020. In connection with the intangibles impairment charge for the third quarter of 2021, the Company wrote-down the associated deferred tax liability by $8.6 million as a benefit.
Net Income (Loss): Net income was $71.7 million, or $0.36 per basic and $0.36 per diluted share, for the third quarter of 2021, compared to net loss of $22.6 million, or $0.19 per basic and diluted share, for the same period in 2020. The change was primarily attributable to favorable changes in non-cash related expenses ($110.4 million, including tax benefit), offset by restructuring charges ($5.5 million) and lower license revenue recognized ($11.2 million).
1 Vysyneum is the proprietary brand name that was conditionally approved by the EMA for oportuzumab monatox in the European Union.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum 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. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design 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 in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s BLA file for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.