On November 5, 2019 Bristol-Myers Squibb Company (NYSE:BMY) ("Bristol-Myers Squibb") reported the extension of the expiration date of the offers to exchange (the "Exchange Offers") notes (the "Celgene Notes") issued by Celgene Corporation (NASDAQ:CELG) ("Celgene") for up to $19,850,000,000 aggregate principal amount of new notes to be issued by Bristol-Myers Squibb Company (the "Bristol-Myers Squibb Notes") and cash and the related consent solicitations (the "Consent Solicitations") being made by Bristol-Myers Squibb on behalf of Celgene to adopt certain proposed amendments (the "Amendments") to the indentures governing the Celgene Notes (Press release, Bristol-Myers Squibb, NOV 5, 2019, View Source;5 [SID1234550290]). Bristol-Myers Squibb hereby extends such expiration date from 5:00 p.m., New York City time, on November 6, 2019, to 5:00 p.m., New York City time, on November 8, 2019 (as the same may be further extended, the "Expiration Date").

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On the early participation date of May 1, 2019, requisite consents were received and supplemental indentures were executed, eliminating substantially all restrictive covenants and certain events of default and other provisions in each of the indentures governing the Celgene Notes. Such supplemental indentures will only become operative upon the settlement date of the Exchange Offers.

The Exchange Offers and Consent Solicitations are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement dated April 17, 2019 and the related letter of transmittal hereby, each as amended by the press releases dated May 1, 2019, May 24, 2019, June 28, 2019, September 23, 2019, October 8, 2019, October 18, 2019, October 30, 2019, November 1, 2019 and as amended hereby, and are conditioned upon the closing of Bristol-Myers Squibb’s acquisition of Celgene (the "Merger"), which condition may not be waived by Bristol-Myers Squibb, and certain other conditions that may be waived by Bristol-Myers Squibb.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and on or about the closing date of the Merger. The closing of the Merger is expected to occur by the end of 2019. As a result, the Expiration Date may be further extended one or more times. Bristol-Myers Squibb will provide notice of any such extension in advance of the Expiration Date.

Except as described in this press release, all other terms of the Exchange Offers and Consent Solicitations remain unchanged.

As of 5:00 p.m., New York City time, on November 4, 2019, the principal amounts of Celgene Notes set forth in the table below had been validly tendered and not validly withdrawn:

Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of Celgene Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" under Rule 144A or not a "U.S. person" and outside the United States under Regulation S for purposes of applicable securities laws. Except as amended by the press releases dated May 1, 2019, May 24, 2019, June 28, 2019, September 23, 2019, October 8, 2019, October 18, 2019, October 30, 2019, November 1, 2019 and as amended hereby, the complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the confidential offering memorandum and consent solicitation statement dated April 17, 2019 and the related letter of transmittal, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470 3900 (U.S. toll-free) or (212) 430 3774 (banks and brokers). The eligibility form is available electronically at: View Source

On November 5, 2019 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported financial results and a corporate update for the quarter ended September 30, 2019 (Press release, CymaBay Therapeutics, NOV 5, 2019, View Source [SID1234550318]).

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"The third quarter marked one of our most productive periods, culminating in reaching target enrollment in ENHANCE, our global, Phase 3 registration study of seladelpar in PBC, earlier than originally projected," said Sujal Shah, President and CEO of CymaBay. "We expect to complete enrollment in ENHANCE by the end of November and remain on track to report topline data from this 52-week study in early 2021. We also made significant progress in our efforts to expand development of seladelpar into a second rare, cholestatic liver disease with the initiation of our Phase 2 dose-ranging study in PSC. As our development activities advance in the coming months, we look forward to topline data from our completed open-label Phase 2 study in PBC, and topline 52-week biopsy data from our Phase 2b study in NASH, in the first and second quarters of 2020, respectively."

Third Quarter and Recent Business Highlights

Reached target enrollment of 240 patients in ENHANCE, our global, Phase 3 registration study of seladelpar for the treatment of primary biliary cholangitis (PBC).
The study is expected to be fully enrolled by the end of November 2019 with topline data release anticipated in early 2021.
Initiated a Phase 2 clinical study of seladelpar in primary sclerosing cholangitis (PSC).
The Phase 2 study is a randomized, placebo-controlled, dose-ranging study that will enroll approximately 100 patients at 60 sites globally.
Patients will be randomized to placebo or seladelpar 5, 10 or 25 mg in a 1:1:1:1 randomization.
The study includes an interim assessment of safety and efficacy after approximately 10 patients in each dose group reach 12 weeks of treatment.
Confirmed additional pharmacodynamic effects in the 12-Week interim analysis of the Phase 2b dose-ranging study in NASH.
Dose-dependent decreases of plasma C4 of up to 55% at 50 mg, a key mechanistic marker of hepatocellular bile acid synthesis.
Dose-dependent increases in carnitine and short-chain acyl carnitines of over 35% considered to be plasma markers of increased lipid metabolism.
No significant effects were observed using the ELF panel, a plasma-based marker of fibrosis, or in corrected-T1, an exploratory magnetic resonance imaging method being developed to identify inflammation associated with NASH. These measures will be assessed at additional timepoints as the study continues.
The study remains blinded until the 52-week liver histology endpoint, expected in 2Q 2020.
Announced acceptance of two abstracts for presentation at The Liver Meeting hosted by the American Association for the Study of Liver Diseases (AASLD) in Boston, MA (November 8-12, 2019).
"Pharmacokinetics of Seladelpar in Patients with Primary Biliary Cholangitis, with or without Cirrhosis" (Publication #1328)
"Structural and Biophysical Characterization of the Origins of the Selectivity of Seladelpar and Elafibranor, Peroxisomal Proliferator Activated Receptor (PPAR) Agonists Targeting Inflammatory Liver Diseases" (Publication #2253)
Third Quarter Financial Highlights & Results

Held $218.6 million in cash, cash equivalents and marketable securities at September 30, 2019. Existing cash is expected to fund the current operating plan into 2021.
Research and development expenses were $23.2 million in the third quarter of 2019 as compared to $17.9 million in the same period of 2018. The increase was primarily driven by higher manufacturing costs incurred to support our ongoing clinical trials and registration batches as well as a severance expense incurred due to the departure of an executive.
General and administrative expenses were $4.5 million in the third quarter of 2019 as compared to $3.3 million in the same period of 2018. The increase was driven primarily by higher employee compensation and other administrative expenses as we hired additional personnel to support our expanding operations.
Net loss was $26.3 million, or ($0.38) per diluted share in the third quarter of 2019, as compared to $18.6 million, or ($0.34) per diluted share in the same period of 2018. Net loss was higher primarily due to increased research and development expenses.
Nine Months Ended September 30, 2019 Financial Highlights & Results

Raised $107.7 million in net proceeds through our March public offering of common stock.
Research and development expenses were $62.9 million in the nine months ended September 30, 2019 as compared to $41.7 million in the same period of 2018. The increase was primarily driven by increases in seladelpar-related clinical trial expenses including enrollment activities related to our ENHANCE PBC Phase 3 clinical study, start-up and enrollment activities related to our PSC Phase 2 clinical study, higher manufacturing costs incurred to support our ongoing clinical trials and registration batches, and execution of other NDA-enabling studies.
General and administrative expenses were $14.7 million in the nine months ended September 30, 2019 as compared to $10.2 million in the same period of 2018. The increase was driven primarily by higher employee compensation expense and other administrative expenses as we hired additional personnel to support our expanding operations.
Net loss was $73.4 million, or ($1.10) per diluted share in the nine months ended September 30, 2019 as compared to $53.1 million, or ($0.93) per diluted share in the same period of 2018. Net loss was higher primarily due to increased research and development expenses.
Conference Call Details
CymaBay management will host a conference call today at 4:30 p.m. ET to discuss third quarter 2019 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13694084. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On November 5, 2019 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that the Company will present phase 1 dose-escalation monotherapy data for PRS-343, a 4-1BB/HER2 bispecific for the treatment of HER2-positive solid tumors, in a late-breaking oral presentation session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, Maryland (Press release, Pieris Pharmaceuticals, NOV 5, 2019, View Source [SID1234550334]).

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"We are pleased to have had our abstract accepted as one of the few late-breaking podium presentations at the conference, and we look forward to sharing an updated dataset for the program on November 9th, including safety, PK, biomarker, and clinical response data for patients enrolled in the highest dose cohorts," said Stephen S. Yoder, President and Chief Executive Officer of Pieris.

Presentation Details

Title: A Phase 1 Dose Escalation Study of PRS-343, a HER2/4-1BB Bispecific Molecule, in Patients with HER2-positive Malignancies
Session: 304
Date/Time: Saturday, November 9, 2019, 11:50 AM EST
Location: Potomac Ballroom, Gaylord National Hotel & Convention Center in National Harbor, Maryland

The presentation will be made available on the publications section of the Company’s website at www.pieris.com.

On November 5, 2019 XOMA Corporation (Nasdaq: XOMA) reported its third quarter 2019 financial results (Press release, Xoma, NOV 5, 2019, View Source [SID1234550350]).

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"XOMA’s portfolio of future potential royalty- and milestone-generating assets grew by 25% in the third quarter with the addition of 15 investigational compounds from Janssen Biotech and Palobiofarma. Since the third quarter of 2018, we have increased the number of assets in our royalty portfolio by 40%. We have firmly established XOMA as a potential source of non-dilutive, non-recourse capital among companies with partnered Phase 2 assets. We continue to assess multiple royalty monetization opportunities that could further expand and diversify our growing portfolio," said Jim Neal, Chief Executive Officer at XOMA.

Recent Updates About Partnered Assets in Development
Novartis listed on ClinicalTrials.gov a Phase 2 safety and efficacy study investigating iscalimab (CFZ533) in children and young adults recently diagnosed with Type 1 diabetes. ClincialTrials.gov Identifier: NCT04129528.

Janssen Biotech listed a Phase 1b study on ClinicalTrials.gov investigating JNJ-64407564 in patients with multiple myeloma. ClinicalTrials.gov Identifier: NCT04108195.

Takeda opened recruitment for its Phase 1 study to evaluate subcutaneous TAK-079 added to standard of care regimens in participants with newly diagnosed multiple myeloma. ClinicalTrials.gov Identifier: NCT03984097.

AVEO Pharmaceuticals listed on ClinicalTrials.gov a Phase 2 study of ficlatuzumab with high-dose cytarabine (HiDAC) and HiDAC alone in adults with relapsed or refractory acute myeloid leukemia. ClinicalTrials.gov Identifier: NCT04100330.

Business Highlights
XOMA acquired a royalty interest in six clinical-stage assets targeting the adenosine pathway for $10.0 million from Palobiofarma S.L., including NIR178, which is being developed by Novartis as a novel checkpoint inhibitor for the treatment of solid tumors. Palobiofarma is developing the other five assets.

The Company significantly increased its portfolio of potential future royalty and milestone payments with the addition of multiple Janssen Biotech, Inc., drug candidates for which XOMA could receive future milestone and royalty payments of 0.75% on net sales.

As a result of Rezolute, Inc.’s successful series of fundraising rounds, XOMA received $4.9 million in milestone payments during the third quarter. During its capital raising activities in the third quarter, Rezolute communicated its intent to commence a Phase 2b study for RZ358 during 2019.

Financial Results
XOMA recorded total revenues of $8.9 million for the third quarter of 2019, compared with $0.9 million in the third quarter of 2018. The increase was due to $6.0 million in revenue recognized from Rezolute and $2.5 million from Janssen Biotech, Inc., under our respective license agreements.

Research and development expenses were $0.1 million for the third quarter of 2019, compared to $0.6 million for the third quarter of 2018. The decrease for the three months ended September 30, 2019, compared to the same period of 2018, was primarily due to a $0.3 million pass-through license fee incurred based on the achievement of a development milestone by one of our partners in the third quarter of 2018 and a $0.2 million decrease in salary and related expenses.

General and administrative expenses were $5.8 million for the third quarter of 2019, compared to $4.7 million for the third quarter of 2018. The increase of $1.1 million for the three months ended September 30, 2019, as compared to the same period of 2018, was primarily due to executing a separation agreement with our Chief Business Officer resulting in $0.5 million in stock compensation expense associated with stock option modifications and $0.4 million in separation benefits.

Total other income, net was $0.8 million for the third quarter of 2019, compared to $0.9 million for the third quarter of 2018. The decrease of $0.1 million was primarily due to income of $0.5 million received in 2018 from Ology Bioservices related to the disposition the Company’s biodefense business in 2016, partially offset by an increase of $0.3 million in sublease income.

Net income for the third quarter of 2019 was $3.2 million, compared to net loss of $4.6 million for the third quarter of 2019.

On September 30, 2019, XOMA had cash of $39.7 million. The Company ended December 31, 2018, with cash of $45.8 million. During the third quarter of 2019, XOMA acquired a royalty interest position on six assets from Palobiofarma, including one asset being developed by Novartis. The $10.0 million Royalty Purchase Agreement with Palobiofarma, was funded with $5.0 million from XOMA’s cash balance and $5.0 million through a drawdown of XOMA’s line of credit from Silicon Valley Bank. The Company’s current cash balance is expected to be sufficient to fund its operations for multiple years.

On November 5, 2019 KIYATEC, Inc. reported that it will present data characterizing in vitro response to checkpoint inhibitors in solid tumors, a capability that addresses an important need in preclinical development of immuno-oncology (I/O) therapies (Press release, KIYATEC, NOV 5, 2019, View Source [SID1234550366]). The data will be presented at the 2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, to be held November 6-10 in National Harbor, MD.

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Biologically relevant replication of complex interactions of human immune cells with tumor cells is an ongoing challenge using traditional preclinical models. Evidence presented by KIYATEC will highlight the utility of its in vitro 3D cell culture technology platform to characterize the tumor biology and immune activation and infiltration that precipitates response to checkpoint inhibitors across multiple solid tumor types. Data includes:

Complex 3D cultures derived from tumor cell lines or primary tumor tissue, incorporating allogeneic or autologous immune cells
High-throughput spheroid models used to detect dose-dependent response to checkpoint blockade and correlate with immune cell activation
Complex microtumor models that mirror immune cell infiltration, therapy-mediated reduction of microtumor growth and secretion of cytokines
"KIYATEC is pioneering advances in 3D cell culture technologies to address the unmet needs of biopharmaceutical companies engaged in pre-clinical testing of their I/O compounds," said Matthew Gevaert, CEO of KIYATEC. "Our emerging I/O models are currently being productively deployed across a number of pre-clinical initiatives and we anticipate that activity to increase as more drug developers become aware of our unique capabilities."

Presentation Details
Following are key details of the SITC (Free SITC Whitepaper) poster presentation:

Poster: P3
Title: Predicting patient response to checkpoint blockade therapy using in vitro 3D cultures
Date and Time: Friday, November 8, 12:30 – 2:00 pm, 6:30 – 8:00 pm, EST