On May 9, 2019 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported its financial results for the first quarter ended March 31, 2019 (Press release, Synlogic, MAY 9, 2019, View Source [SID1234536066]).

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"We made significant progress on our 2019 goals in the first quarter of the year providing a strong foundation for the continued development of our Synthetic Biotic platform and clinical pipeline," said Aoife Brennan, M.B., Ch.B. Synlogic’s president and chief executive officer. "We strengthened our scientific leadership with the appointment of two experienced drug developers, Dr. Scott Plevy, as Chief Scientific Officer, and Dr. Patricia Hurter, who joined our board of directors and brings additional relevant experience in manufacturing. In addition, we have manufactured clinical trial material in-house for our IO program and made significant advances in developing processes to reliably and reproducibly manufacture solid formulations of our orally administered Synthetic Biotic medicines. The new formulation has a more patient-friendly stability profile and provides a path to longer out-patient studies and eventual commercialization."

Recent Highlights

Corporate

Appointment of Scott Plevy, M.D., as Synlogic’s Chief Scientific Officer. Dr. Plevy has responsibility for Synlogic’s research organization. He most recently served as Vice President, Gastroenterology Disease Area Leader and IL-23 Pathway Leader at Janssen Research & Development, LLC, after a successful career in academia. He has served as the lead investigator on multiple early-phase clinical trials, published on a breadth of topics from disease-specific targets to basic immunology and molecular biology, and performed translational research to advance the understanding of novel immunologic interventions in inflammatory bowel disease, other inflammatory conditions, and microbiome-related diseases.
Appointment of Patricia N. Hurter, Ph.D., to Synlogic’s board of directors. Dr. Hurter served as Senior Vice President at Vertex from 2011 to 2019, during which time her responsibilities grew to include all CMC and preclinical development activities of Vertex’s R&D portfolio, as well as the internal GMP manufacturing facility that provides drug substance and product for clinical development and commercial supply. Dr. Hurter also served as Interim Head of Global Regulatory Affairs at Vertex and played a leadership role in the development and commercialization of four transformative therapies for Vertex. Prior to joining Vertex, Dr. Hurter was Director, Formulation Design and Characterization for Merck.
Pipeline

Presentation of data at the Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) demonstrating the development of a robust and reproducible process to generate a solid oral formulation of Synlogic’s Synthetic Bioticmedicine for future studies and potential commercial use. The ASGCT (Free ASGCT Whitepaper) presentation focused on preparation and characteristics of a solid oral preparation of SYNB1618, Synlogic’s Synthetic Biotic medicine for the treatment of phenylketonuria (PKU). The data demonstrate that Synlogic has developed a robust and reproducible process to generate a solid formulation of SYNB1618 with minimal impact on cell viability and phenylalanine consuming activity compared to a liquid formulation that is currently being evaluated in an ongoing Phase 1 /2a clinical study in patients with PKU. Synlogic expects to have data from the Phase 1 /2a study in patients in the third quarter of 2019.
Publication in Science Translational Medicine of first in human clinical data and supporting preclinical data from investigational Synthetic Biotic candidate, SYNB1020. The data support the continued development of SYNB1020 which is currently being evaluated in a Phase 1b/2a clinical trial in patients with cirrhosis and elevated blood ammonia with data expected in the third quarter of 2019.
In-house manufacturing of clinical trial material for Synlogic’s first immuno-oncology program, SYNB1891, a dual innate immune activator. Synlogic expects to file an investigational new drug (IND) application for SYNB1891 in the second half of 2019.
Advancement of investigational Synthetic Biotic medicines to lead optimization stage in AbbVie collaboration. Synlogic and AbbVieare developing an oral treatment for inflammatory bowel disease (IBD).
First Quarter 2019 Financial Results

For the three months ended March 31, 2019, Synlogic reported a consolidated net loss of $12.9 million, or $0.51 per share, compared to a consolidated net loss of $11.2 million, or $0.55 per share, for the corresponding period in 2018. The increase in net loss was primarily due to increases in compensation-related expenses due to increased headcount, as well as increases in research and development expenses to support Synlogic’s advancing clinical programs.

Research and development expenses were $10.4 million for the three months ended March 31, 2019 compared to $8.4 million for the corresponding period in 2018. The increase was primarily due to an increase in compensation-related expenses associated with increased headcount and increased expenses associated with manufacturing and pre-clinical and clinical studies of Synlogic’s Synthetic Biotic programs.

General and administrative expenses for the three months ended March 31, 2019 were $3.7 million compared to $3.6 million for the corresponding period in 2018.

Revenue was $0.3 million for the three months ended March 31, 2019 compared to $0.4 million for the same period in 2018. Revenue for both periods is associated with services performed under Synlogic’s collaboration with AbbVie to develop a Synthetic Biotic medicine for the treatment of IBD.

As of March 31, 2019, Synlogic had cash, cash equivalents, and short-term investments of $109.8 million.

Conference Call & Webcast Information

Synlogic will host a conference call and live webcast today at 5:00 pm ET today, Thursday, May 9, 2019. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Alternatively, investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or +1 (213) 660-0926 from outside the United States. The conference ID number is 2154739. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors and Media section of the Synlogic website.

On May 9, 2019 Medigene AG (FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported that the Company’s strategic partner bluebird bio, Inc. (NASDAQ:BLUE), USA, at its analyst day presentation, will present preclinical data of the first therapeutic T cell receptor (TCR) candidate resulting from the research and development partnership with Medigene (Press release, MediGene, MAY 9, 2019, View Source [SID1234536082]). Furthermore, bluebird bio announced plans to start clinical development in 2020 with this candidate TCR targeting the tumor antigen MAGE-A4, which is expressed on a variety of solid tumor types.

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The presented preclinical data demonstrate a high antigen sensitivity of the MAGE-A4-TCR with strong recognition of tumor cell lines and durable tumor elimination in a subcutaneous in vivo melanoma model. Furthermore, the data show functional responses in both CD8+ and CD4+ T cell populations, suggesting that no co-receptor will be needed for use of the MAGE-A4-TCR in solid tumors. The high functional avidity of this TCR enables it to trigger killing by CD4+ T cells in addition to CD8+ T cells, helping to potentially overcome immune suppression that is often prevalent in solid tumor microenvironments.

bluebird bio revealed its plans to start clinical development for this TCR-T-cell therapy for solid tumors in 2020, and may potentially combine this highly active TCR with other technologies to enhance T cell function in solid tumor microenvironments in next generation programs.

Prof. Dolores Schendel, CEO/CSO of Medigene, comments: "We are excited that already the first TCR discovery project that we performed for our partner bluebird bio yielded a TCR candidate displaying such convincing preclinical data and that it has been selected for clinical development by bluebird bio. This confirms the high quality of Medigene’s TCR discovery platform and supports our confidence in our further projects with bluebird bio"

This is the first collaboration target of Medigene’s partnership with bluebird bio of a potential six TCR products that the companies have agreed to work on together.

To see the full webcast of bluebird bio’s analyst day, please follow this link: View Source

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies with the focus on T cell-receptor modified T cells (TCR-Ts) and has associated projects currently in pre-clinical and clinical development. For more information, please visit View Source

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

Contact Medigene AG
Julia Hofmann, Dr. Robert Mayer
Tel.: +49 – 89 – 20 00 33 – 33 01,
email: [email protected]

On May 9, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported first quarter 2019 financial results (Press release, CytomX Therapeutics, MAY 9, 2019, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-first-quarter-2019-financial" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-first-quarter-2019-financial" rel="nofollow">View Source [SID1234536132]).

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As of March 31, 2019, CytomX had cash, cash equivalents and short-term investments of $396.6 million.

"We continued to make excellent progress developing our differentiated technology platform and lead product candidates during the first quarter," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "Early clinical data from our PROCLAIM CX-072 and PROCLAIM-CX-2009 programs continued to emerge, pointing the way to next steps for these unique assets. Taken together, the developing clinical profiles for CX-072 and CX-2009 validate that the Probody platform has potential to give rise to best in class and first-in-class product candidates for the treatment of cancer. We look forward to providing additional details regarding the advancement of our pipeline as we progress through 2019."

Business Highlights and Recent Developments

PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical Program

CX-072 is a Probody therapeutic targeting PD-L1, a clinically and commercially validated anti-cancer target.
CytomX has previously presented Phase 1 clinical data from PROCLAIM-CX-072 evaluating the safety and activity of CX-072 as monotherapy and in combination with YERVOY (ipilimumab).
• The PROCLAIM-CX-072 Monotherapy dose escalation phase is complete (Parts A and A2). Of 24 efficacy evaluable patients, all with generally weakly immunogenic tumors, and treated with doses greater than or equal to 3 mg/kg of CX-072, 12 (50%) demonstrated tumor shrinkage including four partial responses (one confirmed, 2 unconfirmed, one confirmation pending) as of the February 6, 2019 data cutoff. CX-072 as monotherapy was generally well tolerated. A maximum tolerated dose (MTD) for CX-072 monotherapy was not reached.
• The PROCLAIM-CX-072 combination dose escalation of CX-072 with ipilimumab (Part B1) is complete with the MTD defined as 3 mg/kg of ipilimumab and 10 mg/kg of CX-072. Of 19 patients evaluable for efficacy, four (21%) patients experienced confirmed responses as of the February 6, 2019 data cutoff including one complete response. Among 27 patients treated with CX-072 in combination with ipilimumab at 3 mg/kg or above, the combination was generally well tolerated. Seven (26%) patients reported a Grade 3/4 treatment-related adverse event (TRAE) and 3 (11%) patients reported a Grade 3/4 immune-related adverse event (irAE). These data compare well to historical controls and strongly support the further clinical advancement of this combination.
Updated clinical data from monotherapy expansion cohorts (Part D) of the PROCLAIM-CX-072 program, evaluating the safety and efficacy of CX-072 in multiple tumor types at 10mg/kg, will be presented in a poster and as part of the Poster Discussion Session on Saturday, June 1 at the 2019 Annual Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
• Abstract 2513 – CX-072, a PD-L1 Probody Therapeutic, as Monotherapy in Patients with Advanced Solid Tumors: Preliminary Results of PROCLAIM-CX-072
Next steps in the further advancement of CX-072 are under development.
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program

CX-2009 is a first in class Probody drug conjugate (PDC) that targets CD166, a novel antigen that is broadly and highly expressed in many types of cancer.
During the first quarter, CytomX presented preliminary clinical findings from PROCLAIM-CX-2009 studying CX-2009 as monotherapy in a subset of CD166 expressing cancer types, including certain patients selected for high level CD166 expression (Parts A and A2).
• As of a February 26, 2019 data snapshot, 71 patients at all doses tested were evaluable for efficacy. For patients who received ≥4 mg/kg of CX-2009 and had at least one post-baseline, on-study tumor assessment, 15/39 (38%) achieved tumor shrinkage, including seven unconfirmed partial responses observed in breast cancer, ovarian cancer and head and neck cancer. 29/39 patients (74%) achieved stable disease or better at the time of the first on-treatment scan.
• CX-2009 was generally well tolerated. The MTD was not reached at the highest dose level tested of 10 mg/kg. The most common TRAEs were grade 1 and 2 and included nausea (32%), fatigue (24%) and decreased appetite (23%). The most common grade 3/4 TRAE was keratitis (8%).
Next steps in the further advancement of CX-2009 are under development.
CX-2029 (CD71 Probody Drug Conjugate) Clinical Program

CD71, also known as the Transferrin Receptor, is a highly efficient cellular mechanism for the internalization of antibody drug conjugates in preclinical models.
Given the widespread expression of CD71 on normal tissues, however, it is widely considered to be an undruggable target for clinical purposes using conventional antibody drug conjugate technology.
CytomX discovered and is developing, in collaboration with AbbVie, CX-2029, a CD71-directed Probody Drug Conjugate which has the potential to turn CD71 into a druggable target.
CytomX continues to enroll patients in PROCLAIM-CX-2029, a Phase 1/2 clinical trial evaluating CX-2029 as monotherapy in patients with solid tumors or lymphomas.
BMS-986249 (CTLA-4 Probody Therapeutic) Clinical Program

Bristol-Myers Squibb (BMS), continues enrollment in a Phase 1/2 clinical trial evaluating BMS-986249 alone and in combination with OPDIVO (nivolumab) in solid tumors that are advanced and have spread.
Technology Acquisition from Agensys, Inc.

In January, CytomX announced the acquisition of drug conjugate linker-toxin and CD3-based bispecific technologies from Agensys, Inc., an affiliate of Astellas Pharma Inc. CytomX aims to utilize this technology in the ongoing discovery and development of novel Probody therapeutic candidates.
Appointment of New Director

In April, CytomX announced the appointment of Elaine V. Jones, Ph.D. to the Board of Directors, effective May 1, 2019.
First Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments totaled $396.6 million as of March 31, 2019, compared to $436.1 million as of December 31, 2018.

Revenue was $29.5 million for the three months ended March 31, 2019, compared to $14.2 million for the three months ended March 31, 2018. The increase in revenue of $15.3 million for the current period compared to the corresponding period in 2018 was primarily due to the accelerated recognition of revenue of $17.4 million related to the cessation of research on certain targets under the BMS Agreement in 2019.

Research and development expenses increased by $13.9 million during the three months ended March 31, 2019 compared to the corresponding period in 2018. The increase was attributable to a $5.0 million charge for acquired technical know-how related to drug conjugate linker-toxin and CD3-based bispecific technologies during the current period, an increase of $2.5 million expenses related to laboratory contracts and services and laboratory supplies and equipment, an increase of $2.1 million clinical related expenses resulting from increased clinical trial activities and an increase of $3.4 million in personnel-related expenses due to an increase in headcount.

General and administrative expenses increased by $2.3 million during the three months ended March 31, 2019 compared to the corresponding period in 2018. The increase was attributable to increased personnel-related expense due to an increase in headcount, and increased consulting and professional services primarily due to an increase in tax and accounting compliance activities.

Teleconference Scheduled Today at 5:00 p.m. ET
Conference Call/Webcast Information

CytomX management will host a conference call today at 5:00 p.m. ET. Interested parties may access the live audio webcast of the teleconference through the "Investor & News" section of CytomX’s website at View Source or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) and using the passcode 9496795. An archive of the webcast will be available on the CytomX website from May 9, 2019, until May 16, 2019.

On May 9, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that a conference call will be held, Friday, May 10, 2019 at 8:00 AM ET to discuss results for the first quarter of 2019 and provide a business outlook for the remainder of the year (Press release, TG Therapeutics, MAY 9, 2019, http://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-host-conference-call-first-quarter-2019 [SID1234536009]). Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer will host the call.

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In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics First Quarter 2019 Business Update Call. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for replay on the Company’s website, for a period of 30 days after the call.

TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.

On May 9, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2019 (Press release, Puma Biotechnology, MAY 9, 2019, View Source [SID1234536050]). Unless otherwise stated, all comparisons are for the first quarter 2019 compared to the first quarter of 2018.

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Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Net NERLYNX revenue in the first quarter of 2019 was $45.6 million, compared to net NERLYNX revenue of $36.0 million in the first quarter of 2018.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $10.1 million, or $0.26 per share, for the first quarter of 2019, compared to a net loss of $24.3 million, or $0.65 per share, for the first quarter of 2018.

Non-GAAP adjusted net income was $8.1 million, or $0.21 per basic share and $0.20 per diluted share, for the first quarter of 2019, compared to non-GAAP adjusted net income of $1.1 million, or $0.03 per basic share and $0.02 per diluted share, for the first quarter of 2018. Non-GAAP adjusted net income excludes stock-based compensation expense, which represents a significant portion of overall expense. For a reconciliation of GAAP net loss to non-GAAP adjusted net income and GAAP net loss per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the first quarter of 2019 was $16.1 million, compared to $6.3 million in the first quarter of 2018. At March 31, 2019, Puma had cash and cash equivalents of $48.8 million and marketable securities of $101.6 million, compared to cash and cash equivalents of $108.4 million and marketable securities of $57.0 million at December 31, 2018. Puma’s cash and cash equivalents at March 31, 2019 did not include a $60.0 million upfront license payment that was received in April 2019. At March 31, 2019, the $60.0 million upfront license payment was recorded in accounts receivable.

"Puma experienced lower than expected net product revenue in the first quarter of 2019," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "This reduction in net revenues was the result of an increase in expenses charged against gross revenue for the quarter. Additionally, net product revenue declined in the quarter as a result of an increase in patients discontinuing treatment with NERLYNX."

Mr. Auerbach added, "During 2019, we anticipate the following key milestones for Puma: (i) presenting data from the Phase III trial of neratinib in third-line metastatic breast cancer patients in the second quarter of 2019; (ii) filing a new drug application for neratinib based on the results of the Phase III trial in third-line metastatic breast cancer in the summer of 2019; (iii) meeting with the FDA to discuss the clinical development and regulatory strategy for the SUMMIT trial in the summer of 2019; (iv) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in other countries in the second half of 2019; (v) reporting additional data from the Phase II CONTROL trial in the second quarter of 2019; and (vi) reporting Phase II data from the SUMMIT basket trial in patients with HER2 mutations in the second half of 2019."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, and license revenue. For the first quarter ended March 31, 2019, total revenue was $99.1 million, of which $45.6 million was net NERLYNX revenue and $53.5 million was license revenue received from Puma’s sub-licensees. This compares to total revenue of $66.5 million in the first quarter of 2018, of which $36.0 million was net NERLYNX revenue and $30.5 million was license revenue.

Operating Costs and Expenses

Total operating costs and expenses were $89.2 million for the first quarter of 2019, compared to $89.9 million for the first quarter of 2018.

Cost of Sales:

Cost of sales was $8.0 million for the first quarter of 2019, compared to $6.4 million for the first quarter of 2018.

Selling, General and Administrative Expenses:

Selling, general and administrative expenses were $45.5 million for the first quarter of 2019, compared to $36.6 million for the first quarter of 2018. The $8.9 million increase resulted primarily from increases of approximately $6.8 million for professional fees such as legal fees and marketing and commercial support, approximately $0.9 million related to employee stock-based compensation expense, approximately $0.7 million in payroll and payroll related expenses, and approximately $0.4 million in travel and meeting-related expenses.

Research and Development Expenses:

Research and development (R&D) expenses were $35.7 million for the first quarter of 2019, compared to $46.9 million for the first quarter of 2018. The $11.2 million decrease resulted primarily from decreases of approximately $8.1 million of stock-based compensation, $2.1 million in internal R&D primarily related to payroll and payroll related expenses, $1.5 million in clinical trial expenses primarily due to external clinical service, external manufacturing, testing and logistics, partially offset by increases in CRO-related expenses, grant expenditures and comparator drug expenses.

Total Other Income (Expenses)

Total other expenses were $20.0 million for the first quarter of 2019, compared to total other expenses of $0.9 million for the first quarter of 2018. Other expense recorded in the first quarter of 2019 includes $16.4 million related to a March 2019 jury verdict against Puma in a defamation lawsuit, Eshelman v. Puma Biotechnology, Inc., et al., and represents $22.4 million in damages awarded to the plaintiff, net of a $6.0 million anticipated insurance receivable. Puma intends to appeal the verdict and has filed a motion for a new trial or, in the alternative, a reduced damages award. The plaintiff has also filed motions seeking attorneys’ fees and pre-judgment interest. The total amount of damages to be paid by Puma remains subject to the exhaustion of post-trial motions and appeals.

Conference Call

Puma Biotechnology will host a conference call to report its first quarter 2019 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 9, 2019. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international) at least 10 minutes prior to the start of the call and referencing the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on the company’s website for 90 days.