On May 6, 2019 Unum Therapeutics Inc. (Nasdaq: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies to treat cancer using its novel T cell technology platforms, reported that the company will host a conference call and live audio webcast on Monday, May 13, 2019 at 8:00 a.m. ET to discuss financial results for the first quarter of 2019 (Press release, Unum Therapeutics, MAY 6, 2019, View Sourcenews-releases/news-release-details/unum-therapeutics-host-first-quarter-2019-financial-results" target="_blank" title="View Sourcenews-releases/news-release-details/unum-therapeutics-host-first-quarter-2019-financial-results" rel="nofollow">View Source [SID1234535734]). Unum management will also provide an update on the Company’s recent progress and upcoming milestones.

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Participants may access the conference call by dialing 866-300-3411 (domestic) or 636-812-6658 (international) and refer to conference ID number 1443149. To join the live webcast, please visit the investor relations section of the Unum Therapeutics website at View Source at least 10 minutes before the event begins.

A webcast replay will be available at the same location on the Unum Therapeutics website beginning approximately two hours after the event and will be archived for 90 days.

On May 6, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) in oncology, in particular against rare or resistant cancers, reported a new milestone in the clinical development of AsiDNA with the treatment of the first patient in DRIIV-1b, a phase 1b clinical study of AsiDNA, a first-in-class tumor DNA repair inhibitor, in combination with carboplatin and with carboplatin plus paclitaxel, in patients with solid tumors eligible to such treatments (Press release, Onxeo, MAY 6, 2019, View Source [SID1234535758]).

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DRIIV-1b is an extension of the DRIIV-1 (DNA Repair Inhibitor administered IntraVenously) phase 1 study currently being completed, in which AsiDNA, administered intravenously (IV) demonstrated its intratumoral activity by inducing a significant increase in its activity biomarkers in the tumor cells of patients, with a favorable safety profile at various active doses.

At the active dose of 600 mg, among the three patients included in the cohort, two patients with relapsed, multi-treated metastatic colorectal cancer were controlled with medical imaging, which showed no further disease progression after the second treatment cycle, and continued their treatment with AsiDNA for three months. The 600 mg active dose was considered to be optimal for further development of AsiDNA in combination with chemotherapy.

DRIIV-1b aims at showing the safety and efficacy of a 600 mg dose of AsiDNA in combination with carboplatin, and carboplatin plus paclitaxel, in up to 18 patients with solid tumors eligible for such treatments (lung, breast, ovarian or head and neck cancers, …). The efficacy of the combinations will be evaluated every six to eight weeks by medical imaging in accordance with RECIST criteria (Response evaluation criteria in solid tumors). The study will take place in Belgium, and initial results are expected in the second half of 2019.

Dr Nuria Kotecki of the Institute Jules Bordet in Brussels commented: "The «DDR» (DNA Damage Response) approach represents a particularly interesting alternative in cancer treatment. Indeed, combining AsiDNA, a tumor DNA repair inhibitor, with agents such as carboplatin, that causes breaks in that same DNA, is a very promising approach in terms of synergistic efficacy. On the basis of the safety profile of AsiDNA observed in monotherapy, this combination can be considered as we are looking for greater efficacy without aggravating the toxicity observed with chemotherapy. We are thrilled to start this DRIIV-1b study, which should enable us to confirm the preclinical and clinical results already obtained."

This first combination trial represents a major milestone in the clinical development of AsiDNA. Thanks to its highly differentiated mechanism of action, confirmed by exhaustive preclinical studies, the combination of AsiDNA with various anti-cancer treatments appears especially relevant to increase their efficacy and avoid the occurrence of resistance from tumors.

DRIIV-1b is the first combination study of AsiDNA by IV administration, aimed at confirming such synergistic efficacy on tumors for which the medical needs remain immense. Positive results from this study will represent a proof of the interest of AsiDNA combined with chemotherapy and will open the door to further clinical development of AsiDNA IV in a phase 2 program in one or several indications.

Olivier de Beaumont, Onxeo’s Chief Medical Officer, concluded: "This study marks the start of the clinical development of AsiDNA in combination with chemotherapy. The results, expected by the end of the year, will enable us to confirm the potential of our flagship product in indications with strong medical needs. Other combination studies are also being prepared to further support the growing interest in AsiDNA and its broad clinical potential. We are very pleased to be continuing our collaboration with Dr Nuria Kotecki, a clinical investigator already involved in the DRIIV-1 study, and we thank her for her help and support in this promising research program."

On May 6, 2019 Gilead Sciences, Inc. (Nasdaq: GILD) reported that Robin L. Washington, Gilead’s Executive Vice President and Chief Financial Officer, and John McHutchison, AO, MD, Gilead’s Chief Scientific Officer and Head of Research & Development, will participate in a fireside chat at the Bank of America Merrill Lynch 2019 Health Care Conference in Las Vegas on Tuesday, May 14 at 10:00 a.m. Pacific Time (Press release, Gilead Sciences, MAY 6, 2019, View Source [SID1234535838]).

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The audio portion of the fireside chat will be accessible live through the company’s Investors page at View Source Please connect to the company’s website at least 15 minutes prior to the start of the presentation to ensure adequate time for any software download that may be required to listen to the webcast. The replay will be available for 14 days following the presentation.

On may 6, 2019 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported financial results for the first quarter ended March 31, 2019 (Press release, Adaptimmune, MAY 6, 2019, View Source [SID1234535735]). Adaptimmune shared a clinical update in a separate release (https://bit.ly/2IJpltR).

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Financial Results for the three-month period ended March 31, 2019

·Cash / liquidity position: As of March 31, 2019, Adaptimmune had cash and cash equivalents of $49.9 million and Total Liquidity(1) of $168.2 million.

·Revenue: Revenue for the three-month period ended March 31, 2019 was nil, compared to $8.2 million for the same period in 2018. No revenue has been recognised for the three months ended March 31, 2019 as the NY-ESO SPEAR T-cell transition program and the PRAME pre-clinical development program were completed in 2018, and work has not commenced on the third target nominated by GSK under the Collaboration and License Agreement.

·Research and development ("R&D") expenses: R&D expenses for the three-month period ended March 31, 2019 were $22.0 million, compared to $25.7 million for the same period of 2018; this decrease being primarily due to a reduction in expenditure associated with NY-ESO, which was transferred to GSK on July 23, 2018.

· General and administrative ("G&A") expenses: G&A expenses for the three-month period ended March 31, 2019 were $11.8 million, compared to $11.2 million for the same period of 2018.

· Other income, net: Other income for the three-month period ended March 31, 2019 was $5.4 million, compared to $7.1 million for the same period of 2018. Other income primarily comprises unrealized foreign exchange gains, which fluctuate depending on exchange rate movements and the amount of foreign currency assets and liabilities.

· Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three-month period ended March 31, 2019 was a loss of $27.4 million, ($(0.04) per ordinary share) compared to a loss of $21.1 million ($(0.04) per ordinary share) in the same period of 2018.

Financial guidance

The Company believes that its existing cash, cash equivalents and marketable securities will fund the Company’s current operations into the third quarter of 2020.

(1) Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below.

On May 6, 2019 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported its financial results for the three months ended March 31, 2019 and provided a corporate update (Press release, Protalix, MAY 6, 2019, View Source;p=RssLanding&cat=news&id=2397172 [SID1234535759]).

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"In the first three months of 2019, we have continued to execute on enrollment in our PRX-102 studies and have worked to prepare ourselves for a potential accelerated approval path," said Mr. Moshe Manor, Protalix’s President and Chief Executive Officer. "In addition, we are encouraged by the initial pharmacokinetic (PK) data from our BRIGHT study, which were presented at the 15th Annual WORLDSymposiumTM 2019 in February 2019, that demonstrate the potential for PRX-102 to be infused once-monthly, compared to the current treatment regimen of every two weeks."

First Quarter 2019 and Recent Clinical and Corporate Highlights

The Company’s BRIGHT phase III clinical trial of pegunigalsidase alfa, or PRX-102, for the treatment of Fabry disease is currently one patient away from completion of enrollment.

The Company’s BALANCE phase III clinical trial of pegunigalsidase alfa for the treatment of Fabry disease is currently eleven patients away from completion of enrollment.

The Company presented results from the BRIGHT Study at the 15th Annual WORLD Symposium showing that infusion of pegunigalsidase alfa every 4 weeks results in the presence of continuous active enzyme throughout the entire infusion interval.

The Company is scheduled to present three posters during the 6th Update on Fabry Disease international conference being held in Prague, Czech Republic, on May 26-28, 2019.

To date, more than 40 patients are being treated in the Company’s various extension studies after opting to continue treatment with pegunigalsidase alfa after they completed an initial study.

The Company plans to meet with the U.S. Food and Drug Administration (FDA) for a follow up meeting during the second quarter of 2019 in connection with the potential accelerated approval filing path for pegunigalsidase alfa.
First Quarter 2019 Financial Results

The Company recorded total revenues of $10.4 million during the three months ended March 31, 2019, compared to $6.7 million for the same period of 2018. The increase is primary attributable to the recognition of $6.9 million of license revenues in the three months ended on March 31, 2019 compared to the recognition of $2.2 million in the same period of 2018.

Research and development expenses for the three months ended March 31, 2019, were $11.7 million, compared to $7.3 million for the same period in 2018. Selling, general and administrative expenses for the three months ended March 31, 2019 were $2.2 million, compared to $2.5 million incurred during the same period in 2018.

Net loss for the three months ended March 31, 2019 was $7.3 million compared to $7.2 million for the three months ended March 31, 2018.
On March 31, 2019, the Company had $30.4 million of cash and cash equivalents, compared to $37.8 million at March 31, 2018, which is currently projected to fund operations into mid-2020. As of March 31, 2019, the Company had outstanding $57.9 million of its 7.50% convertible promissory notes due November 2021.
Conference Call and Webcast Information

The Company will host a conference call on Monday, May 6, 2019, at 8:30 am ET to review the clinical, corporate and financial highlights.

To participate in the conference call, please dial the following numbers prior to the start of the call: United States: +1-844-358-6760; International: +1-478-219-0004. Conference ID number 6169584.

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.