On November 9, 2020 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, 2020 (Press release, Sesen Bio, NOV 9, 2020, View Source [SID1234570524]). The Company’s lead program, VicineumTM, also known as VB4-845, is currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In December 2019, the Company initiated the BLA submission for Vicineum to the FDA under Rolling Review.

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"We are rapidly advancing toward the finalization of our BLA in December as well as a potential MAA submission in Europe in early 2021," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We believe the probability of regulatory success is high in both the US and Europe due to the strong clinical profile of Vicineum enabled by the unique dual mechanism of action. Once approved, we think Vicineum has the potential to be the best-in-class therapeutic in BCG-unresponsive NMIBC with a significant global commercial opportunity. We remain laser-focused towards executing on upcoming key milestones to the benefit of both patients and shareholders."

Manufacturing Update

Manufacturing and release testing of the three drug substance PPQ batches has been completed and all quality acceptance criteria were met. Manufacturing of the three drug product batches has also been completed and release testing has been completed for the first and second batch, with all quality acceptance criteria met. Testing of the third drug product PPQ batch is expected to be completed in November 2020. Based on the results obtained thus far, the Company is confident that the remaining batch will also meet the required acceptance criteria in support analytical comparability.

As part of the analytical comparability plan submitted to the FDA, the Company also committed to conduct extensive biophysical characterization and forced degradation testing on Vicineum manufactured using the proposed commercial process. These studies were completed in October 2020, and the Company believes the data demonstrates that clinical and commercial material are highly similar, providing strong support for analytical comparability.

EMA Regulatory Process

On October 23, 2020, the Company completed a successful Pre-Submission meeting with the European Medicines Agency (EMA) for Vicineum. During the meeting, the EMA provided updated guidance on various administrative topics, which help to clarify the regulatory path forward. In addition, earlier in 2020, the EMA provided written notice of the Company’s eligibility to file a MAA under the EMA’s centralized procedure. These interactions with the EMA in 2020 confirm the Company’s pathway to a MAA submission for Vicineum in early 2021 with anticipated approval in early 2022.

Supply Chain

The Company recently announced an exclusive agreement with Cardinal Health for third-party logistics and specialty pharmaceutical distribution services related to the commercial distribution of Vicineum in the United States. The addition of Cardinal Health completes the selection of major supply chain partners in support of the commercial distribution of Vicineum in the United States. All of Sesen Bio’s major supply chain partners, including Fujifilm, Baxter and Cardinal Health, are recognized leaders within the industry, which the Company believes will help to ensure manufacturing and distribution excellence.

OUS Partnership

On July 31, 2020, the Company announced an exclusive license agreement with Qilu Pharmaceutical for the development and commercialization of Vicineum in Greater China. On September 29, 2020, the Company received $10.0 million in net proceeds associated with the $12 million upfront payment due under the license agreement. Under the terms of the agreement, the Company is also eligible to receive (i) a 12% royalty, subject to certain reductions, based upon annual net sales of Vicineum in Greater China, and (ii) payments totaling up to $23 million upon the achievement of certain technology transfer, development and regulatory milestones, the first of which the Company expects to receive in early 2021.

Third Quarter 2020 Financial Results

Cash Position: Cash and cash equivalents were $42.0 million as of September 30, 2020, compared to $48.1 million as of December 31, 2019. This change includes $8.2 million of net proceeds received during the third quarter of 2020 provided by our ATM offering.
Revenue: Revenue for the third quarter of 2020 was $11.2 million, which was due to the recognition of revenue from the Company’s license agreement with Qilu. The Company did not record any revenue for the third quarter of 2019.
R&D Expenses: Research and development expenses for the third quarter of 2020 were $10.2 million compared to $6.6 million for the same period in 2019. The third quarter increase was due primarily to costs related to the ongoing technology transfer process with Fujifilm and Baxter as the Company scales-up for commercial manufacturing, partially offset by lower clinical expenses related to the Phase 3 VISTA trial for Vicineum and lower regulatory consulting fees in support of the Company’s ongoing BLA submission with the FDA.
G&A Expenses: General and administrative expenses for the third quarter of 2020 were $4.1 million compared to $3.2 million for the same period in 2019. The third quarter increase was due primarily to increases in investment banking and legal fees related to the Company’s license agreement with Qilu.
Net Loss: Net loss was $22.6 million, or $0.19 per basic share and diluted share, for the three months ended September 30, 2020, compared to a net loss of $13.1 million, or $0.13 per basic and diluted share, for the same period in 2019. The change was due primarily to revenue recognized in the third quarter of 2020 related to the Company’s license agreement with Qilu, offset by higher technology transfer costs and a non-cash change in fair value of contingent consideration due to changes in discount rates.
Conference Call and Webcast Information

Members of the Sesen Bio management team will host a conference call and webcast today at 8:00 AM ET to review the Company’s financial results and provide a general business update. To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 9360749. The webcast can be accessed in the Investor Relations section of the Company’s website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the Company’s website at www.sesenbio.com for 60 days following the call.

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 VicineumTM 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 Vicineum 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 Vicineum

Vicineum, 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). 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 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 Vicineum 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 Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. 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.

On November 9, 2020 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported that the company will present data at multiple upcoming scientific/medical conferences (Press release, NeoImmuneTech, NOV 9, 2020, View Source [SID1234570523]). These include three poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting, occurring November 10-15, and an oral presentation at the Society for Neuro-Oncology (SNO) annual meeting, occurring November 19-22. Details of the presentations are as follows:

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SITC Meeting:

Title: Efficacy and safety of GX-I7 plus pembrolizumab for heavily pretreated patients with metastatic triple negative breast cancer: The Phase 1b/2 KEYNOTE-899 Study.
Poster Number: 322
Category: In-Progress Clinical Trials
Location: View Source

Title: Combination of rhIL-7-hyFc and anti-PD-L1xCD3ε bispecific antibody enhances antitumor response in mice.
Poster Number: 450
Category: Combination Immunotherapies
Location: View Source

Title: A novel long-acting interleukin-7 agonist, NT-I7, increases cytotoxic CD8+ T cells and enhances survival in mouse glioma models.
Poster Number: 565
Category: Immune-stimulants and immune modulators
Location: View Source

Date/Time: All odd numbered posters will be presented on Wednesday, Nov. 11, from 5:15-5:45 p.m. EST and Friday, Nov. 13, from 4:40-5:10 p.m. EST. Even numbered posters will be presented on Thursday, Nov. 12, from 4:50-5:20 p.m. EST and Saturday, Nov. 14, from 1-1:30 p.m. EST.
Posters will be on display from 8 a.m. on Monday, Nov. 9, until the virtual poster hall closes on December 31, 2020.

SNO Meeting:

Title: A novel long-acting interleukin-7 agonist, NT-I7, increases cytotoxic CD8 cells and enhances survival in mouse glioma models
Session Number: EXTH-14
Session Name: Experimental and Translation Sciences Session III
Date/Time: On demand
Location: View Source

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On November 9, 2020 Foundation Medicine, Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneLiquid CDx to be used as a companion diagnostic for LYNPARZA (olaparib). As a companion diagnostic, FoundationOne Liquid CDx will use a blood-based biopsy to identify patients with BRCA1, BRCA2 and/or ATM alterations in metastatic castration-resistant prostate cancer (mCRPC) who may be appropriate for treatment with LYNPARZA (Press release, Foundation Medicine, NOV 9, 2020, View Source [SID1234570522]). FoundationOne Liquid CDx, Foundation Medicine’s liquid biopsy test was approved by the FDA in August to report genomic alteration results for patients with any solid tumor.

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Prostate cancer is the second most common cancer in men globally and despite progress made toward new treatment modalities, the mortality rate for this condition remains high.[1] Of critical importance is ensuring metastatic prostate cancer patients receive comprehensive genomic profiling (CGP) via liquid or tissue-based biopsies to determine eligibility for new targeted treatment options like LYNPARZA. Foundation Medicine’s tissue-based comprehensive genomic profiling test, FoundationOneCDx, was approved as a companion diagnostic for LYNPARZA in May 2020.

"With this latest companion diagnostic approval, physicians now have the option to choose either tissue or liquid-based comprehensive genomic testing based on their patients’ need and condition. Since tissue availability can be an issue for some metastatic prostate cancer patients, blood-based testing is an important option to consider and critically important for informing patient care," said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. "The approval of this companion diagnostic will allow more patients to access genomic testing, regardless of specimen type, and provide oncologists with another tool to guide personalized treatment decisions."

Using a blood sample, FoundationOne Liquid CDx analyzes over 300 cancer-related genes for genomic alterations. The CGP test is now approved as a companion diagnostic for seven targeted therapies across four tumor types.

LYNPARZA was approved for mCRPC patients who carry mutations in homologous recombination repair (HRR) genes, based on the PROfound study, which was supported by Foundation Medicine and was the first positive phase III biomarker-selected study using a molecularly targeted treatment in men with mCRPC. The PROfound trial is the largest prospective Phase III study to date performing central tissue testing for HRR gene mutations in mCRPC patients. LYNPARZA is jointly developed and commercialized by AstraZeneca (LSE/STO/Nasdaq: AZN) and Merck & Co., Inc.

As a laboratory professional service which has not been reviewed or approved by the FDA, the FoundationOne Liquid CDx report delivers information about the genomic signatures microsatellite instability (MSI) and blood tumor mutational burden (bTMB), as well as single gene alterations, including NTRK fusions, to help inform the use of other therapies including immunotherapies. Also, as a laboratory professional service, the report provides relevant clinical trial information and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.

About FoundationOne Liquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit View Source

On November 9, 2020 Seres Therapeutics, Inc., (Nasdaq: MCRB) reported financial results from the third quarter ended September 30, 2020, and provided business updates (Press release, Seres Therapeutics, NOV 9, 2020, View Source [SID1234570521]).

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"Supported by our positive, highly significant SER-109 Phase 3 results, we expect SER-109 to be the first-ever microbiome therapy approved by the U.S. FDA. Following those remarkable SER-109 study data and a significant capital infusion, Seres is in the midst of transformational growth toward becoming a commercial-stage microbiome company, with a broad portfolio of promising therapeutic candidates. We are expanding our field-leading capabilities across R&D, manufacturing, and commercial operations to maximize the multitude of opportunities we see for our approach," said Eric Shaff, President and Chief Executive Officer of Seres. "Our immediate priorities are to drive enrollment in our SER-109 open-label study to fulfill our safety database requirements and prepare to file a Biologics License Application (BLA), while also preparing the Company for the potential commercialization of SER-109."

"In tandem, we continue to advance our deep microbiome pipeline, including SER-287, SER-301, SER-401, and SER-155. These therapeutic candidates span infectious diseases, inflammatory disease, and cancer, and we believe all have the potential to fundamentally improve upon the current standard of care. Most recently, we were pleased to dose the first subject in our SER-301 Phase 1b study in patients with ulcerative colitis. Moving forward, we expect to reach a number of value-creating milestones across multiple therapeutic areas," concluded Mr. Shaff.

Program and Corporate Updates

SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection: SER-109 is an investigational, oral, biologically-derived microbiome therapeutic that is designed to reduce recurrence of C. difficile infection (CDI), enabling patients to achieve a sustained clinical response by breaking the vicious cycle of CDI recurrence and restoring the diversity of the gastrointestinal microbiome.

In August, Seres announced topline results from ECOSPOR III, demonstrating that SER-109 met the study’s primary endpoint, showing a 30.2% absolute reduction of recurrence of CDI compared to placebo at eight weeks post-treatment. The SER-109 treatment arm relative risk was 0.27 (95% CI=0.15 to 0.51) versus placebo. The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective. Based on feedback from the FDA and the strength of the SER-109 Phase 3 data, Seres believes that ECOSPOR III will be a single pivotal efficacy study supporting product registration.

In October, Seres presented the Phase 3 study result and additional data from ECOSPOR III at the virtual American College of Gastroenterology (ACG) Annual Scientific Meeting. These new data showed that at 12 weeks post-treatment the rate of recurrence in the SER-109 arm was 16.7%, compared to a rate of 47.8% in the placebo arm, representing an absolute risk reduction of 31.1% (relative risk 0.35; 95% CI=0.21-0.58; p-value <0.001), consistent with the results seen at eight weeks. Additionally, these new findings demonstrate that SER-109 administration resulted in similar efficacy when groups are stratified by age (i.e., ≥ or <65 years) or prior antibiotic received (i.e., vancomycin or fidaxomicin), which is important in this patient population. The number needed to treat (NNT) at 12 weeks is approximately 3, similar to the figure calculated based on eight-week study results.

The SER-109 manufacturing process inactivates vegetative bacteria and other potential pathogens, which have been linked with fecal microbiota transplant (FMT)-associated disease transmission. Seres believes that this unique manufacturing process provides a critically important safety advantage.

Following the topline Phase 3 study results, the FDA reaffirmed its prior guidance regarding the efficacy requirements to support a SER-109 BLA submission, which were exceeded by the positive SER-109 ECOSPOR III study results, and reaffirmed its prior guidance that the safety database prelicensure should be at least 300 subjects.

Seres is conducting an ongoing SER-109 open-label study in patients with recurrent CDI (ClinicalTrials.gov identifier: NCT03183128), which also admits patients with a single recurrence of CDI, to expand the SER-109 safety database. The Company continues to make progress activating new clinical sites and enrolling subjects into the study. Additional information is available at serescdiffstudy.com.

SER-287 Phase 2b ECO-RESET study in ulcerative colitis: SER-287 is an oral, biologically-derived microbiome therapeutic candidate designed to have pharmacological effects on multiple pathways relevant to ulcerative colitis that can be modulated by the gastrointestinal microbiome. Seres has obtained FDA Fast Track designation for SER-287 in active mild-to-moderate UC.

The SER-287 Phase 2b ECO-RESET induction study in patients with active mild-to-moderate UC is ongoing. Seres has implemented a number of COVID-19-related mitigation strategies and the study continues to enroll patients. The study is over 75% enrolled.

SER-301 Phase 1b study first patient dosed: In November, the Company announced that the first patient has been dosed in its Phase 1b study for SER-301, an oral, rationally-designed, fermented microbiome therapeutic. SER-301 is being evaluated in a Phase 1b study in adults with mild-to-moderate ulcerative colitis. The study is being conducted in Australia and New Zealand and targets the enrollment of approximately 65 subjects.

A first open-label cohort of 15 subjects will evaluate safety and pharmacokinetics (PK), as measured by bacterial engraftment. In the subsequent second cohort, 50 subjects will be randomized to receive either SER-301 or placebo. The objectives for this cohort are to evaluate drug safety and PK, and to evaluate clinical remission and other measures of efficacy as secondary endpoints.

The consortium of bacteria in SER-301 is designed to modify the microbiome and microbe-associated metabolites in the gastrointestinal tract and modulate pathways linked to gastrointestinal inflammation and epithelial barrier integrity in patients with ulcerative colitis. The design of SER-301 has incorporated learnings from the SER-287 Phase 1b study related to the microbiome signatures associated with clinical efficacy.

Seres is entitled to receive a $10 million milestone payment associated with the Phase 1b SER-301 clinical study initiation from Nestlé Health Science, the Company’s ex-North American collaborative partner for this program.

SER-401 Phase 1b study in metastatic melanoma: SER-401 is an orally-administered, biologically-derived, live microbiome therapeutic candidate comprising bacteria that reflect the bacterial signature in the gastrointestinal microbiome associated with patient response to checkpoint inhibitor immunotherapy.

The ongoing placebo-controlled Phase 1b study in patients with metastatic melanoma is supported by the Parker Institute for Cancer Immunotherapy and the University of Texas MD Anderson Cancer Center. The trial is examining safety, tolerability, and drug activity via microbiome engraftment and its association with biomarkers of clinical response in tumor biopsies in patients treated with SER-401 in combination with nivolumab, an approved anti-PD-1 checkpoint inhibitor therapy.

SER-155 Phase 1b clinical study activities: Seres continues to advance SER-155, an oral, rationally-designed, fermented microbiome therapeutic, toward a Phase 1b clinical study. SER-155 is designed to prevent mortality due to gastrointestinal infections, bacteremia, and graft versus host disease (GvHD) in immunocompromised patients, including patients receiving allogeneic hematopoietic stem cell transplantation. SER-155 is a consortium of bacterial species designed using microbiome biomarker data from human clinical data, human cell-based assays, and in vivo disease models. The composition aims to decrease infection and translocation of antibiotic-resistant bacteria in the gastrointestinal tract and modulate host immune responses to decrease GvHD.

The SER-155 program is supported by a CARB-X grant that provides financial and operational support through Phase 1b clinical development. The Company intends to advance SER-155 into a Phase 1b study early next year in collaboration with Memorial Sloan Kettering Cancer Center.

Strengthened leadership team: In October, Seres announced the appointments of David Ege Ph.D., as Executive Vice President and Chief Technology Officer, and Jayne Gansler as Executive Vice President and Chief People Officer. John Aunins, Seres’ prior Chief Technology Officer, will continue to provide support to the Company as a Senior Advisor.

Dr. Ege joins Seres from Merck, where he held a variety of technical and leadership roles in R&D and manufacturing in the U.S. and Switzerland. He has more than 15 years of experience in the pharmaceutical industry, with a focus on vaccine and biologics manufacturing, facility development and process optimization.

Ms. Gansler has more than 20 years of global human resources experience in the biotechnology, pharmaceutical, and medical device industries. Prior to Seres, she was Head of Human Resources of ARIAD Pharmaceuticals. Earlier in her career, she served as Global Head of Human Resources for Genzyme, a Sanofi Company.

Financial Results

Seres reported a net loss of $30.3 million for the third quarter of 2020, as compared with a net loss of $16.4 million for the same period in 2019. The third quarter net loss was driven primarily by clinical and development expenses, personnel expenses and ongoing development of the Company’s microbiome therapeutics platform.

Research and development expenses for the third quarter of 2020 were $23.9 million, compared with $18.3 million for the same period in 2019. The research and development expenses were primarily related to Seres’ late-stage SER-109 and SER-287 clinical development programs.

General and administrative expenses for the third quarter of 2020 were $7.6 million, compared with $5.9 million for the same period in 2019. General and administrative expenses were primarily due to consulting fees and professional fees and included expenses to support SER-109 commercialization readiness activities.

Seres ended the third quarter with approximately $320.3 million in cash, cash equivalents and short and long-term investments compared with $63.9 million at the end of the second quarter 2020. In August 2020, the Company completed a public equity offering and sold common stock to Nestlé through a private Securities Purchase Agreement, which together provided approximately $264 million in net proceeds.

Conference Call Information

Seres’ management will host a conference call today, November 9, 2020, at 8:30 a.m. ET. To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 1038426. To join the live webcast, please visit the "Investors and News" section of the Seres website at www.serestherapeutics.com.

A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.

About SER-109

SER-109 is an investigational, oral, biologically-sourced microbiome therapeutic that is designed to reduce recurrence of C. difficile infection (CDI), enabling patients to achieve a sustained clinical response by breaking the vicious cycle of CDI recurrence and restoring the diversity of the gastrointestinal microbiome. SER-109 is a consortium of purified Firmicute bacteria in spore form, manufactured by fractionating targeted bacteria from the stool of healthy human donors with further steps to inactivate potential pathogens. The FDA has granted SER-109 Breakthrough Therapy designation and Orphan Drug designation for the treatment of recurrent CDI.

SER-109 is fundamentally distinct from fecal microbiota transplantation (FMT) and FMT-like products. SER-109 is comprised of a highly purified consortium of commensal bacteria in spore form, manufactured in accordance with Current Good Manufacturing Practice (cGMP) conditions using stringent standards to ensure product quality and consistency. To support product safety, Seres utilizes a unique manufacturing process designed to inactivate numerous potential pathogens, including species of non-spore bacteria, such as Escherichia coli, and viruses such as SARS-CoV-2.

About C. difficile Infection (CDI) and Current Treatments

C. difficile infection (CDI) is one of the top three most urgent antibiotic-resistant bacterial threats in the U.S., according to the Centers for Disease Control, and is a leading cause of hospital-acquired infection in the U.S. It is responsible for the deaths of approximately 20,000 Americans each year. CDI is associated with debilitating diarrhea, which significantly impacts quality of life in every functional domain. Since the discovery of C. difficile more than four decades ago, vancomycin has been the drug most commonly used for patient management. Current approaches provide only modest improvements in sustained clinical response rates, leaving behind a significant pool of patients with recurrent disease. Unapproved FMT, used in cases that are not responsive to approved drugs, remains poorly characterized clinically and has been associated with serious safety concerns, including the transmission of bacterial pathogens and the potential transmission of viruses such as SARS-CoV-2, the virus that causes COVID-19. The recent quarantine and shipping hold of FMT material from a major stool bank highlights the urgent need for an approved effective and safe treatment for recurrent CDI.

On November 9, 2020 TScan Therapeutics, a biopharmaceutical company focused on the development of T-cell receptor (TCR)-engineered T cell therapies in oncology, reported that management will present virtually at the following upcoming medical meeting and healthcare conferences (Press release, TScan Therapeutics, NOV 9, 2020, View Source [SID1234570520]):

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The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (SITC) (Free SITC Whitepaper)

Gavin MacBeath, Ph.D., Chief Scientific Officer, will present an e- poster entitled "Discovery of TSC-100: A Natural HA-1-specific TCR to Treat Leukemia Following Hematopoietic Stem Cell Transplant Therapy". The poster will be available for viewing in the Virtual Poster Hall on Monday, November 9, 2020, at 8:00 a.m. Eastern Time.
Jefferies London Global Healthcare Conference

David Southwell, Chief Executive Officer, will present a company overview on Thursday, November 19, 2020, at 10:50 a.m. Eastern Time.
3rd Annual Evercore ISI HealthCONx Conference

Mr. Southwell will participate in a panel discussion entitled "Finders Keepers: Identifying New Cancer Targets with Atreca, TScan Therapeutics" on Wednesday, December 2, 2020, at 10:30 a.m. Eastern Time.