On November 1, 2018 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported business highlights and financial results for the third quarter ended September 30, 2018 (Press release, Fate Therapeutics, NOV 1, 2018, View Source [SID1234530566]).

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"We continue to see strong momentum in the enrollment of our Phase 2 PROTECT study of ProTmune, and an encouraging set of initial clinical data for FATE-NK100 is emerging across the dose-escalation phases of three Phase 1 clinical trials. In addition, we are poised to achieve a significant milestone for Fate Therapeutics as well as the entire cell therapy field, as we continue working with the FDA on the allowance of our landmark IND application for FT500, a first-of-kind, off-the-shelf NK cell product derived from a clonal master iPSC line," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "At ASH (Free ASH Whitepaper), we plan to share preclinical data across our entire pipeline of off-the-shelf NK cell and CAR T-cell product candidates that demonstrate the unique value in using clonal engineered master iPSC lines as a renewable source for manufacture and delivery of cell-based cancer immunotherapies."

Clinical Programs

Exceeded 50% Enrollment in Phase 2 PROTECT Study of ProTmune. The randomized, controlled and double-blinded Phase 2 PROTECT study of ProTmune is over 50% enrolled. The clinical trial is intended to enroll a total of 60 adult subjects with hematologic malignancies undergoing allogeneic hematopoietic cell transplantation (HCT). Subjects are being randomized, in a 1:1 ratio, to receive either ProTmune or a conventional matched unrelated donor hematopoietic cell graft. New clinical data from the seven subjects receiving ProTmune in the Phase 1 PROTECT study, including data on key secondary endpoints assessing disease-free survival and freedom from chronic graft-versus-host disease (GvHD), cancer relapse, and death at one-year following HCT, will be featured at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in a poster presentation.
20th Subject Treated across Three Phase 1 Studies of FATE-NK100. The twentieth subject has been treated with FATE-NK100, the Company’s first-in-class, donor-derived adaptive memory NK cell cancer immunotherapy, across the dose-escalation phases of three Phase 1 clinical trials. At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, the Company plans to hold an investor event and share new clinical data of FATE-NK100, including safety, persistence and anti-tumor activity, in advanced hematologic malignancies and solid tumors. An oral presentation at the 2018 ASH (Free ASH Whitepaper) Annual Meeting will describe a next-generation, GMP-compliant protocol, established by Dr. Karl-Johan Malmberg under the Company’s research collaboration with Oslo University Hospital, that enables robust ex vivo expansion of adaptive memory NK cells having homogeneous expression of a single inhibitory killer cell immunoglobulin-like receptor (KIR).
Universal Off-the-Shelf Cancer Immunotherapy Preclinical Pipeline

Submitted First-of-Kind IND Application to FDA for FT500. In July, the Company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for FT500, a universal, off-the-shelf NK cell product derived from a clonal master induced pluripotent stem cell (iPSC) line. In response to a request by the FDA, the Company is conducting additional adventitious agents testing of the master iPSC bank used for the production of FT500, and intends to submit these test results to the FDA during the fourth quarter of 2018. Upon FDA allowance of the IND, the Company expects to begin clinical investigation of FT500 in combination with FDA-approved checkpoint inhibitors in subjects with advanced solid tumors.
Achieved IND-Enabling Milestone under FT516 CIRM Grant. In September, the Company received a $1.1 million milestone payment under its California Institute for Regenerative Medicine (CIRM) award for the preclinical development of FT516, a universal, off-the-shelf NK cell product candidate derived from a clonal master iPSC line engineered to uniformly express a high-affinity, non-cleavable CD16 Fc receptor. Since CD16 binds to the Fc region of tumor-targeted antibodies, FT516 can be combined with FDA-approved monoclonal antibody therapy to target a broad spectrum of tumor-associated antigens. The Company expects to submit an IND application to the FDA by the end of 2018 for first-in-human clinical investigation of FT516 in combination with CD20 antibody rituximab and with SLAMF7 antibody elotuzumab.
Five Presentations covering iPSC Product Platform Scheduled for ASH (Free ASH Whitepaper). Two oral presentations, including new preclinical data of FT500 in combination with checkpoint inhibitors and initial preclinical data of engineered iPSC-derived NK cells in combination with target-cell specific engagers, were accepted for presentation at the ASH (Free ASH Whitepaper) Annual Meeting. Additionally, three poster presentations on other product candidates emerging from the Company’s iPSC product platform, including the Company’s first iPSC-derived chimeric antigen receptor (CAR) T-cell (FT819) and CAR NK cell (FT519) product candidates, are scheduled for presentation.
Corporate Highlights

Entered into iPSC-derived CAR T-cell Collaboration with ONO Pharmaceutical. In September 2018, the Company entered into a Collaboration and Option Agreement with Ono Pharmaceutical Co. Ltd. for the joint development and commercialization of two off-the-shelf, iPSC-derived CAR T-cell product candidates. Fate Therapeutics is entitled to receive up to $70 million during the preclinical option stage of the collaboration. In addition, in connection with the development and commercialization of the product candidates, the Company is eligible to receive up to $1.2 billion in aggregate milestone payments, plus tiered royalties on net sales by Ono.
Extended iPSC Technology Leadership Position to include CRISPR-based Cell Reprogramming. In September, the Company exclusively licensed intellectual property from the J. David Gladstone Institutes that covers the generation of iPSCs using CRISPR-mediated gene activation. This new approach uses CRISPR to induce pluripotency by directly targeting a specific location of the genome and activating endogenous gene expression, and does not rely on established methods of cellular reprogramming that require the transduction of multiple transcription factors.
Completed $144 Million Common Stock Offering. In September, the Company closed an underwritten public offering of 10,648,149 shares of its common stock at a public offering price of $13.50 per share.
Third Quarter 2018 Financial Results

Cash & Short-term Investment Position: Cash, cash equivalents and short-term investments as of September 30, 2018 were $211.2 million compared to $100.9 million as of December 31, 2017. The increase was primarily driven by $134.9 million in net cash proceeds received by the Company from its September 2018 public offering of common stock. These proceeds were offset by the Company’s use of cash to fund operating activities.
Total Revenue: Revenue was $1.0 million for the third quarter of 2018 as well as for the same period in 2017. All revenue was derived from the Company’s research collaboration and license agreement with Juno Therapeutics.
R&D Expenses: Research and development expenses were $13.6 million for the third quarter of 2018, compared to $8.6 million for the same period in 2017. In the third quarter of 2018, the Company incurred a one-time $1.4 million expense associated with the in-license of intellectual property from the J. David Gladstone Institutes covering the use of CRISPR for cellular reprogramming and iPSC generation. The remaining increase in R&D expenses was primarily attributable to an increase in expenses associated with the clinical development of FATE-NK100 and with the preclinical development of the Company’s iPSC-derived product candidates, including regulatory and manufacturing activities to support the submission of its FT500 IND application, and in employee compensation associated with growth in headcount.
G&A Expenses: General and administrative expenses were $4.1 million for the third quarter of 2018, compared to $2.8 million for the same period in 2017. The increase in G&A expenses was primarily attributable to an increase in advisory fees, including audit and legal fees, and in employee compensation.
Shares Outstanding: Common shares outstanding were 64.5 million as of September 30, 2018 and 52.6 million as of December 31, 2017. Preferred shares outstanding as of September 30, 2018 and December 31, 2017 were 2.8 million, each of which is convertible into five shares of common stock. All preferred shares outstanding are from the Company’s sale and issuance of non-voting Class A convertible preferred stock to Redmile Group, LLC in November 2016.
Today’s Conference Call and Webcast
The Company will conduct a conference call today, Thursday, November 1, 2018 at 5:00 p.m. ET to review financial and operating results for the quarter ended September 30, 2018. In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 6998539. The live webcast can be accessed under "Events & Presentations" in the Investors & Media section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

About ProTmune
ProTmune is an investigational next-generation hematopoietic cell graft for the prevention of acute graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT). ProTmune is manufactured by pharmacologically modulating a donor-sourced, mobilized peripheral blood graft ex vivo with two small molecules (FT1050 and FT4145) to decrease the incidence and severity of acute GvHD while maintaining the anti-leukemia activity of the graft. ProTmune has been granted Orphan Drug and Fast Track Designations by the U.S. Food and Drug Administration, and Orphan Medicinal Product Designation by the European Commission. ProTmune is currently being investigated in a randomized, controlled and double-blinded Phase 2 clinical trial in adult subjects with hematologic malignancies undergoing matched unrelated donor HCT.

About FATE-NK100
FATE-NK100 is an investigational, first-in-class, allogeneic donor-derived natural killer (NK) cell cancer immunotherapy comprised of adaptive memory NK cells, a highly specialized and functionally distinct subset of activated NK cells expressing the maturation marker CD57. Higher frequencies of CD57+ NK cells in the peripheral blood or tumor microenvironment in cancer patients have been linked to better clinical outcomes. In August 2017, non-clinical data describing the unique properties and anti-tumor activity of FATE-NK100 were published by Cancer Research (doi:10.1158/0008-5472.CAN-17-0799), a peer-reviewed journal of the American Association of Cancer Research. Three clinical trials of FATE-NK100 are currently being conducted: VOYAGE for the treatment of refractory or relapsed acute myelogenous leukemia; APOLLO for the treatment of recurrent ovarian cancer; and DIMENSION for the treatment of advanced solid tumors, including in combination with monoclonal antibody therapy.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary iPSC product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event, and selecting a single iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf to treat many patients. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 100 issued patents and 100 pending patent applications.

On November 1, 2018 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported its financial results for the three and nine months ended September 30, 2018 (Press release, Eagle Pharmaceuticals, NOV 1, 2018, View Source [SID1234530583]). Highlights of and subsequent to the third quarter of 2018 include:

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Business and Recent Highlights:

Commenced a $50.0 million accelerated share repurchase (the "ASR") as part of a new $150.0 million share repurchase authorization;
Announced that the Company’s fulvestrant formulation did not meet the primary bioequivalence endpoints evaluating Eagle’s formulation compared to FASLODEX in its open label, randomized, pharmacokinetic ("PK") and safety study conducted in 600 healthy female volunteers across multiple U.S. sites;
Entered into an agreement with the United States Army Medical Research Institute of Chemical Defense ("USAMRICD"), the nation’s leading science and technology laboratory in the area of medical chemical countermeasures research and development, to conduct a study to evaluate the neuroprotective effects of RYANODEX (dantrolene sodium);
Appointed David Pernock to the position of Chief Operating Officer;
Completed enrollment of the Company’s second clinical study to further evaluate the safety and efficacy of RYANODEX for the treatment of exertional heat stroke ("EHS"), an investigational new indication for the product;
Named to the Fortune 100 List of Fastest-Growing Companies, ranking 16th overall, including achieving the #1 positions for EPS 3-year growth of 392% and revenue 3-year growth of 109%; and
United States Patent and Trademark Office ("USPTO") issued patent number 10,052,385 for BENDEKA. The USPTO has now issued or allowed a total of 16 patents in the BENDEKA family of patents expiring from 2026 to 2033.
Financial Highlights:

Third Quarter 2018

Total revenue for the third quarter of 2018 was $51.3 million, compared to $63.0 million in the third quarter of 2017, which included a $12.5 million milestone payment for BENDEKA;
Eagle launched bendamustine hydrochloride 500ml solution ("Big Bag") on May 15, 2018 and Big Bag product sales were $8.0 million in the third quarter of 2018; for the week ending October 19, 2018, the Company achieved market share of 5% according to IMS Health;
Q3 2018 RYANODEX product sales were $3.5 million, up 9% compared to Q3 2017;
Q3 2018 net income was $14.0 million, or $0.94 per basic and $0.91 per diluted share, compared to net income of $15.4 million, or $1.03 per basic and $0.98 per diluted share in Q3 2017;
Q3 2018 Adjusted Non-GAAP net income was $18.3 million, or $1.22 per basic and $1.18 per diluted share, compared to Adjusted Non-GAAP net income of $19.2 million, or $1.27 per basic and $1.22 per diluted share in Q3 2017; and
Cash and cash equivalents were $91.2 million, accounts receivable was $78.5 million, and debt was $45.0 million as of September 30, 2018.
Reiterating 2018 Expense Guidance:
R&D expense is expected to be in the range of $46.0 – $50.0 million ($40.0 – $44.0 million on a non-GAAP basis)
SG&A expense is expected to be in the range of $61.0 – $64.0 million ($44.0 – $47.0 million on a non-GAAP basis)
"While we were disappointed in the outcome of the fulvestrant trial, we believe in the strength of the remaining products in our pipeline and our ability to generate long-term meaningful earnings. We are conducting a confirmatory study with the U.S. military to evaluate RYANODEX as a treatment for nerve agent exposure and continue to make progress on an intramuscular formulation. And, we maintain a positive view of a potential exertional heat stroke application. We are also advancing our vasopressin and pemetrexed assets. Consequently, we have decided to expand our share repurchase program to $150 million," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"The $50 million of Eagle stock we purchased as part of an ASR represents the confidence of management and the Board of Directors in the value we are building at Eagle. As a publicly traded company, Eagle has raised an aggregate $110 million of equity capital. With the ASR completed, as of November 1, 2018, we have now repurchased $154 million of Eagle stock, without levering the balance sheet. With a strong base business, an exciting pipeline and growing cash position, we expect to continue building long-term value for shareholders," concluded Tarriff.

Third Quarter 2018 Financial Results

Total revenue for the three months ended September 30, 2018 was $51.3 million, as compared to $63.0 million for the three months ended September 30, 2017. Royalty revenue was $35.2 million, compared to $43.6 million in the third quarter of 2017. BENDEKA royalties were $33.8 million, compared to $41.4 million in the third quarter of 2017. A summary of total revenue is outlined below:

Research and development expenses decreased to $6.0 million for the third quarter of 2018, compared to $9.0 million in the third quarter of 2017. The year over year decrease reflects a substantial reduction in fulvestrant and pemetrexed expenses in the third quarter of 2018, partially offset by the cost of the EHS trial. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the third quarter of 2018 was $5.0 million.

SG&A expenses decreased to $13.9 million in the third quarter of 2018 compared to $16.7 million in the third quarter of 2017. The year over year decrease reflects lower external legal costs as well as a reduction in EHS marketing expenses. Excluding stock-based compensation and other non-cash and non-recurring items, third quarter 2018 SG&A expense was $9.7 million.

Net income for the third quarter of 2018 was $14.0 million, or $0.94 per basic and $0.91 per diluted share, compared to net income of $15.4 million, or $1.03 per basic and $0.98 per diluted share in the three months ended September 30, 2017, due to the factors discussed above.

Adjusted Non-GAAP net income for the third quarter of 2018 was $18.3 million, or $1.22 per basic and $1.18 per diluted share, compared to Adjusted Non-GAAP net income of $19.2 million or $1.27 per basic and $1.22 per diluted share in the third quarter of 2017. For a full reconciliation of Adjusted Non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

Liquidity

As of September 30, 2018, the Company had $91.2 million in cash and cash equivalents and $78.5 million in net accounts receivable, $53.2 million of which was due from Teva Pharmaceutical Industries Ltd. The Company had $45.0 million in outstanding debt.

In the third quarter of 2018, we purchased $12.1 million of Eagle’s common stock as part of our expanded $100 million share buyback program. From August 2016 through November 1, 2018, we have repurchased $154.0 million of our common stock, including the $50.0 million ASR. As disclosed on October 30, 2018, the Company’s Board of Directors retired the prior share repurchase program and approved a new $150.0 million share repurchase authorization (including the entry into the ASR).

Conference Call

As previously announced, Eagle management will host its third quarter 2018 conference call as follows:

Date Thursday, November 1, 2018
Time 8:30 A.M. EDT
Toll free (U.S.) 877-876-9173
International 785-424-1669
Webcast (live and replay)
www.eagleus.com, under the "Investor + News" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-2459 (US) or 402-220-7218 (International) and entering conference call ID EGRXQ318. The webcast will be archived for 30 days at the aforementioned URL.

On November 1, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported its financial results for the third quarter ended September 30, 2018 (Press release, Puma Biotechnology, NOV 1, 2018, View Source [SID1234530615]). Unless otherwise stated, all comparisons are for the third quarter 2018 compared to the third quarter 2017.

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Net product revenue in the third quarter of 2018 was $52.6 million, compared to net product revenue of $6.1 million in the third quarter of 2017. Puma Biotechnology received approval from the U.S. Food and Drug Administration (FDA) for NERLYNX (neratinib) for the treatment of early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy on July 17, 2017, and the Company began shipment to wholesalers at the end of July 2017.

Based on generally accepted accounting principles in the United States (GAAP), Puma reported a net loss applicable to common stock of $14.2 million, or $0.37 per share, for the third quarter of 2018, compared to a net loss applicable to common stock of $77.2 million, or $2.07 per share, for the third quarter of 2017. Net loss applicable to common stock for the first nine months of 2018 was $82.9 million, or $2.19 per share, compared to $227.9 million, or $6.15 per share, for the first nine months of 2017.

Non-GAAP adjusted net income was $6.6 million, or $0.17 per basic share and $0.16 per diluted share, for the third quarter of 2018, compared to non-GAAP adjusted net loss of $50.7 million, or $1.36 per share, for the third quarter of 2017. Non-GAAP adjusted net loss for the first nine months of 2018 was $14.5 million, or $0.38 per basic and diluted share, compared to non-GAAP adjusted net loss of $144.7 million, or $3.90 per share, for the first nine months of 2017. Non-GAAP adjusted net income (loss) excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. For a reconciliation of GAAP net loss to non-GAAP adjusted net income (loss) and GAAP net loss per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the third quarter of 2018 was $7.3 million. Net cash used in operating activities for the first nine months of 2018 was $31.2 million. At September 30, 2018, Puma had cash and cash equivalents of $68.3 million and marketable securities of $59.7 million, compared to cash and cash equivalents of $81.7 million at December 31, 2017.

"The third quarter of 2018 marked the achievement of another important milestone for Puma with the European Commission granting marketing authorisation for NERLYNX for the extended adjuvant treatment of hormone receptor positive HER2-positive early stage breast cancer," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We expect this new medicine to be commercially available to patients in Europe in 2019, beginning with the expected launch in Germany during the first half of 2019 and followed by additional countries throughout Europe in the second half of 2019."

"We also continue to drive toward expanding availability of NERLYNX throughout the world," Mr. Auerbach added. "In the third quarter, our New Drug Submission was accepted in Canada, and our

licensing partner in China, CANbridge Pharmaceutical Inc., received confirmation that the country’s National Medical Products Administration accepted its New Drug Application for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, following adjuvant trastuzumab based-therapy."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) reporting data from the Phase III NALA trial in third-line metastatic breast cancer patients in the fourth quarter of 2018 or first half of 2019; (ii) submitting for regulatory approval of NERLYNX for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries in the fourth quarter of 2018 and first half of 2019; (iii) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2018; (iv) reporting additional data from the Phase II SUMMIT trial in the fourth quarter of 2018 or first half of 2019; and (v) meeting with the FDA in the first quarter of 2019 to discuss the clinical development and regulatory strategy for neratinib in HER2 mutated cancers based on the results of the ongoing SUMMIT Phase II trial."

Revenue

Total revenue consists of net product revenue from sales of NERLYNX, Puma’s first and only commercial product to date, and license revenue. For the third quarter of 2018, total revenue was $62.6 million, of which $52.6 million was net product revenue and $10.0 million was license revenue received from one of Puma’s sub-licensees. For the first nine months of 2018, total revenue was $179.9 million, of which $139.4 million was net product revenue and $40.5 million was license revenue. The FDA approved NERLYNX for commercial sale in the United States in July 2017 and Puma commenced shipment to wholesalers in late July.

Operating Costs and Expenses

Operating costs and expenses were $73.9 million for the third quarter of 2018, compared to $83.5 million for the third quarter of 2017. Operating costs and expenses for the first nine months of 2018 were $256.0 million, compared to $234.9 million for the first nine months of 2017.

Cost of Sales:

Cost of sales was $9.0 million for the third quarter of 2018 and $24.3 million for the first nine months of 2018, compared to $1.5 million for the third quarter and first nine months of 2017. The Company had no product sales prior to the third quarter of 2017.

Selling, General and Administrative Expenses:

Selling, general and administrative expenses were $28.5 million for the third quarter of 2018, compared to $32.5 million for the third quarter of 2017. SG&A expenses for the first nine months of 2018 were $105.2 million, compared to $75.8 million for the first nine months of 2017. The $29.4 million year-to-date increase was attributable to increases of approximately $26.9 million in internal expenses, such as payroll and payroll-related expenses attributable to the addition of a salesforce since the third quarter of 2017. External expenses declined approximately $1.5 million during the same time period and employee stock-based compensation increased approximately $4.0 million, primarily related to the addition of sales staff to support the commercial launch of NERLYNX in the United States. Puma expects SG&A expenses in 2018 and into 2019 to remain higher than in 2017 as it markets NERLYNX commercially in the United States and launches the product in other territories.

Research and Development Expenses:

Research and development (R&D) expenses were $36.4 million for the third quarter of 2018, compared to $49.5 million for the third quarter of 2017. R&D expenses for the first nine months of 2018 were $126.5 million, compared to $157.5 million for the first nine months of 2017. The $31.0 million year-to-date decrease resulted primarily from decreases of approximately $18.9 million in stock-based compensation and of approximately $15.4 million for external expenses related to clinical trials, manufacturing and logistics associated with clinical supply. Puma expects R&D expenses in 2018 to continue to decline slightly when compared with R&D expenses in 2017 based on a decline in clinical trial activities as existing trials continue to wind down.

On November 1, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, reported that company management will host a conference call at 4:30 p.m. ET on Thursday, November 8, 2018 to discuss third quarter financial results and provide a general corporate update (Press release, Tetraphase, NOV 1, 2018, View Source [SID1234530632]).

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The conference call may be accessed by dialing 844-831-4023 (U.S. and Canada) or 731-256-5215 (international) and entering conference ID number 3997765. A live audio webcast of the conference call, or the subsequent archived recording, will be available online from the "Investors – Events & Presentations" section of the Tetraphase website at www.tphase.com.

A replay of the conference call will be available from 7:30 p.m. ET on Thursday, November 8, 2018, through 7:30 p.m. ET on Thursday, November 15, 2018 by dialing 855-859-2056 (U.S. and Canada) and 404-537-3406 for (international) callers. The conference ID number is 3997765. A replay of the webcast will be available for 90 days by visiting Tetraphase’s website.

On November 1, 2018 F-star, a clinical-stage biopharmaceutical company pioneering the development of novel bispecific antibodies that target the immune system to fight cancer, reported that it will present preclinical data on two new proprietary bispecific antibodies at the SITC (Free SITC Whitepaper) Annual Meeting, PEGS Summit Europe and the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress (Press release, f-star, NOV 1, 2018, View Source [SID1234530648]).

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Checkpoint antagonists dominate the clinical landscape and yet despite encouraging progress, only a small patient population reaches a durable and clinically meaningful response. Current approaches have shown limited efficacy for poorly immunogenic tumours which harness different and often multiple escape or resistance mechanisms to attenuate the local immune response.

FS120 is a dual agonist mAb² simultaneously targeting OX40 (CD134, TNFRSF4) and CD137 (4-1BB). FS222 is an agonist/antagonist mAb² against CD137 and PD-L1 (Programmed Death-Ligand 1). Both OX40 and CD137 are co-stimulatory molecules, part of the Tumour Necrosis Factor Receptor Super Family (TNFRSF). Unlike checkpoint antagonists, engagement of OX40 or CD137 on activated T cells triggers a positive signal that enhances several cellular and effector functions, essential to the elimination of tumour cells.

Neil Brewis, CSO of F-star said "It is only recently that the full complexity of tumour heterogeneity and how this translates into the clinical setting has been appreciated. With the increase in tumour resistance to checkpoint therapies, there is an urgent need to generate new and efficacious treatment options for cancer patients. F-star’s new programmes have the potential to leverage a more targeted, potent and safer immune response, even in highly immune-suppressive tumour microenvironments."

The data to be presented will highlight the potent anti-tumour activity of F-star’s mAb² and how each of them outperforms combinations of monospecific agents in multiple syngeneic tumour models. Furthermore, the results will describe how F-star’s bispecific format can alleviate some of the inherent limitations of an antibody-mediated TNFRSF activation, such as low efficacy or dose-dependent liver toxicity observed in current clinical trials.

Eliot Forster, CEO of F-star said "I am very excited about the presentation of these wholly owned molecules to these conferences. The data on FS120 a dual agonist mAb² and FS222 an agonist/antagonist mAb² demonstrate the versatility and power of our Modular Antibody Technology and its ability to address the known heterogeneity of tumour types and, especially, their immune evasion mechanisms. With the potential to go beyond combination approaches, the two programmes are heading towards INDs in 2019, reinforcing F-star’s commitment to deliver life-changing treatments for cancer patients".

Details of the presentations are below:

SITC Annual Meeting – 7-11 Nov 2018 – Washington DC

Oral presentation information:

Title: FS120 mAb², a dual agonist bispecific antibody targeting OX40 and CD137, activates T cells in vitro and induces potent, FcγR-independent anti-tumour activity
Session: Next Generation Bispecifics and Antibody-Like Molecules
Session date and time: 11 Nov from 08:05-10:30

Poster presentations information:

Title: FS120 mAb², a dual agonist bispecific antibody targeting OX40 and CD137, activates T cells in vitro and induces potent, FcγR-independent anti-tumour activity
Abstract poster number: O44
Poster hall location: Hall E
Poster hall hours: 09 Nov from 08:00 – 20:00 and 10 Nov from 08:00 – 20:30
Poster presentation hours: 10 Nov from 12:20 – 13:50 and 19:00 – 20:30

Title: A novel CD137/PD-L1 bispecific antibody modulates the tumour microenvironment by activating CD8+ T cells and results in tumour growth inhibition
Abstract poster number: P631
Poster hall location: Hall E
Poster hall hours: 09 Nov from 08:00 – 20:00 and 10 Nov from 08:00 – 20:30
Poster presentation hours: 09 Nov from 12:45 – 14:15 and 18:30 – 20:00

PEGS Summit Europe 2018 – 12-16 Nov 2018 – Lisbon

Oral presentation information:

Title: Agonist bispecific antibodies delivering the next Immuno-Oncology breakthrough Session: Advancing Bispecifics and Combination Therapy to the Clinic
Presentation time: 15 Nov at 11:15

ESMO Immuno-Oncology Congress – 13-16 Dec 2018 – Geneva

Poster presentation information:

Title: Optimising TNFRSF Agonism and Checkpoint Blockade with a Novel CD137/PD-L1 Bispecific Antibody
Abstract: 444
Session date and time: 14-15 Dec, lunch time