On May 7, 2019 CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using its CytoSorb blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, reported financial and operational results for the quarter ending March 31, 2019 (Press release, Cytosorbents, MAY 7, 2019, View Source [SID1234535859]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

First Quarter 2019 Financial Results:

Total revenue for Q1 2019 was $5.2 million, including both product sales and grant income, compared to $4.9 million in Q1 2018
Product sales for Q1 2019 were $4.6 million, compared to $4.4 million for Q1 2018. Adjusted first quarter 2019 product sales would have been approximately $4.9 million, after reflecting changes in the Euro to dollar exchange rate between periods
Direct sales continue to expand and achieved new highs, reflecting 18% quarterly growth year-over-year, and 4% sequential growth compared to Q4 2018. Results do not yet materially reflect additions to the sales infrastructure, and new direct territories added in Q1 2019
Distributor sales were affected by anticipated short-term issues from three distributors. As disclosed previously, Fresenius Medical Care is transitioning to new exclusive sales territories (e.g. Mexico, South Korea, Czech Republic) while maintaining France and Finland, and did not order in Q1 2019 as it sells through non-transferable European product inventory. Meanwhile, two other distributors temporarily paused from ordering to rebalance inventory, but have strong and growing end user demand for CytoSorb. We expect these issues to resolve before or during the second half of 2019
Product gross margins for Q1 2019 and Q1 2018 were 74%
Strong cash position of $19.6 million at March 31, 2019
First Quarter 2019 Operational Highlights:

Exceeded 61,000 cumulative CytoSorb treatments delivered, an increase from 40,000 a year ago
Expanded partnership with Fresenius Medical Care to include an expansion of its exclusive distribution agreement to sell CytoSorb in Mexico, South Korea, and the Czech Republic, while maintaining France and Finland
Following a review of the first 50 patients, the independent Data Safety Monitoring Board (DSMB) and Scientific Advisory Board (SAB) recommended continuation of the German government-funded REMOVE endocarditis trial. The trial has now enrolled 180 patients, or nearly 75% of the targeted 250 patients, at 15 active sites
The REFRESH 2-AKI company-sponsored pivotal trial has increased enrollment to 79 patients at 23 clinical trial sites, and has attained approximately 20% of a targeted 400 patient enrollment
HemoDefend-RBC tooling delays have been resolved, parts have been manufactured, and clinical trial devices are being assembled. Meanwhile, an FDA investigational device exemption (IDE) submission is targeted for the second half of this year. A contract research organization (CRO) has been selected to manage the pivotal trial and has begun clinical site negotiations
Hosted the 6th International CytoSorb Users Meeting in Brussels, Belgium, in connection with the 39th International Symposium of Intensive Care and Emergency Medicine (ISICEM)
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents Corporation stated, "Q2 2019 product sales are expected to return to our historical growth trajectory, and are anticipated to be the highest quarterly product sales reported in our history. In addition, we continue to forecast strong revenue growth for all of 2019, despite a slow start in Q1, based on numerous growth opportunities we see."

Dr. Chan continued, "Specifically, we anticipate CytoSorb direct sales will continue strengthening and accelerate into the second half of this year, driven by organic growth, our investments in a larger direct sales team – particularly in Germany, reimbursement, contributions from new direct territories including Poland, Netherlands, and Scandinavia, new clinical data and applications, and other catalysts."

"In addition, we believe the factors that impacted Q1 indirect sales are short-term and specific to the three distributors as described above. For example, Fresenius (FMC) is selling through its European inventory of CytoSorb in France and Finland, while it begins sales in the Czech Republic and pursues registration of CytoSorb in both Mexico and South Korea. It is expected that FMC will order new CytoSorb devices for these countries once registration is achieved. We are encouraged that each of these customers has increased their commitment to selling CytoSorb, including aggressively pursuing new indications, increasing resource allocation, and working closely with our company to drive success. Importantly, we see end-user demand increasing in their territories, based on the excellent foundation they have established. Over the next several quarters, we expect a resumption of ordering from all three groups. Of special note, we do not require these orders to achieve our guidance for Q2 2019." Dr. Chan concluded, "Lastly, we reiterate our guidance on expanding our blended product gross margins to 80% on a quarterly basis this year."

"Please join us on our earnings conference call today, details for which are below."

Conference Call Details:
Date: Tuesday, May 7, 2019
Time: 4:45 PM Eastern Time
Participant Dial-In: 877-451-6152
Conference ID: 13690052
Live Presentation Webcast: View Source

It is recommended that participants dial in approximately 10 minutes prior to the start of the call. There will also be a simultaneous live webcast of the conference call that can be accessed through the following audio feed link: View Source

An archived recording of the conference call will be available under the Investor Relations section of the Company’s website at View Source

Results of Operations

Comparison for the three months ended March 31, 2019 and 2018:

Revenues:

Revenue from product sales was approximately $4,577,000 in the three months ended March 31, 2019, as compared to approximately $4,433,000 in the three months ended March 31, 2018 an increase of approximately $144,000, or 3%. This increase was driven by an increase in direct sales of approximately $624,000 resulting from sales to both new customers and repeat orders from existing customers, offset by a decrease in distributor sales of approximately $480,000. In addition, first quarter 2019 sales were negatively impacted by $363,000 as a result of the decrease in the average exchange rate of the Euro. For the three months ended March 31, 2019, the average exchange rate of the Euro to the U.S. dollar was $1.14 as compared to an average exchange rate of $1.23 for the three months ended March 31, 2018.

Grant income was approximately $615,000 for the three months ended March 31, 2019 as compared to approximately $491,000 for the three months ended March 31, 2018, an increase of approximately $124,000 or 25%. This increase was a result of timing of certain grant revenue and income recognized from a new grant.

Total revenues were approximately $5,192,000 for the three months ended March 31, 2019, as compared to total revenues of approximately $4,925,000 for the three months ended March 31, 2018, an increase of approximately $267,000, or 5%.

Cost of Revenues:

For the three months ended March 31, 2019 and 2018, cost of revenue was approximately $1,739,000 and $1,568,000, respectively, an increase of approximately $171,000. Product cost of revenues increased approximately $52,000 during the three months ended March 31, 2019 as compared to the three months ended March 31, 2018 due to increased sales. Product gross margins were approximately 74% for each of the three months ended March 31, 2019 and 2018.

Research and Development Expenses:

For the three months ended March 31, 2019, research and development expenses were approximately $2,419,000 as compared to research and development expenses of approximately $1,725,000 for the three months ended March 31, 2018. The increase of approximately $694,000 was due to an increase in clinical trial costs of approximately $888,000, which is primarily related to our REFRESH 2-AKI trial and an increase in non-clinical research and development salary related costs of approximately $9,000. These increases were offset by an increase in direct labor and other costs being deployed toward grant-funded activities of approximately $118,000, which had the effect of decreasing the amount of our non-reimbursable research and development costs, a decrease in new product development costs of approximately $67,000 and a decrease of other non-clinical research and development costs of approximately $18,000.

Legal, Financial and Other Consulting Expense:

Legal, financial and other consulting expenses were approximately $562,000 for the three months ended March 31, 2019, as compared to approximately $416,000 for the three months ended March 31, 2018. The increase of approximately $146,000 was due to an increase in legal fees of approximately $167,000 related to patent matters and certain corporate initiatives and an increase in consulting fees of approximately $18,000. These increases were offset by a decrease in employment agency fees of approximately $36,000 and a decrease in accounting fees of approximately $3,000.

Selling, General and Administrative Expense:

Selling, general and administrative expenses were approximately $4,758,000 for the three months ended March 31, 2019, as compared to approximately $4,317,000 for the three months ending March 31, 2018. The increase of $441,000 was due to an increase in salaries, commissions and related costs of approximately $424,000, an increase in travel and entertainment and other costs of approximately $142,000, additional sales and marketing costs, which include advertising and conferences of approximately $88,000, an increase in royalty expenses of approximately $7,000 due to the increase in product sales, an increase in rent expense of approximately $11,000 related to the expansion of manufacturing and office facilities and an increase in other general and administrative cost increases of approximately $21,000. These increases were offset by a decrease in non-cash stock compensation of approximately $252,000.

Interest Expense, net:

For the three months ended March 31, 2019, interest expense was approximately $205,000, as compared to interest expense of approximately $239,000 for the three months ended March 31, 2018. This decrease in interest expense of approximately $34,000 is due to an increase in interest earned on our cash balances during the three months ended March 31, 2019.

Gain (Loss) on Foreign Currency Transactions:

For the three months ended March 31, 2019, the loss on foreign currency transactions was approximately $(393,000) as compared to a gain of approximately $358,000 for the three months ended March 31, 2018. The 2019 loss is directly related to the decrease in the exchange rate of the Euro to the U.S. dollar at March 31, 2019 as compared to December 31, 2018. The exchange rate of the Euro to the U.S. dollar was $1.12 per Euro at March 31, 2019, as compared to $1.15 per Euro at December 31, 2018. The 2018 gain is directly related to the increase in the exchange rate of the Euro at March 31, 2018 as compared to December 31, 2017. The exchange rate of the Euro to the U.S. dollar was $1.23 per Euro at March 31, 2017 as compared to $1.07 per Euro at December 31, 2017.

History of Operating Losses:

We have experienced substantial operating losses since inception. As of March 31, 2019, we had an accumulated deficit of approximately $174,408,000, which included losses of approximately $4,884,000 and $2,982,000 for the three-month periods ended March 31, 2019 and 2018, respectively. Historically, losses have resulted principally from costs incurred in the research and development of our polymer technology, clinical studies, and general and administrative expenses.

Liquidity and Capital Resources

Since inception, our operations have been primarily financed through the issuance of debt and equity securities. At March 31, 2019, we had current assets of approximately $24,828,000 including cash on hand of approximately $19,647,000, and current liabilities of approximately $6,711,000.

We believe that we have sufficient cash to fund our operations into 2020.

2019 Second Quarter Revenue Guidance

CytoSorbents has not historically given specific financial guidance on quarterly results until the quarter has been completed. However, Q2 2019 product sales are expected to return to our historical growth trajectory, and are anticipated to be the highest quarterly product sales reported in our history.

For additional information, please see the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 filed on March 7, 2019 on View Source

On May 7, 2019 Pacira BioSciences, Inc. (NASDAQ: PCRX) reported that it will present at the following two healthcare conferences (Press release, Pacira Pharmaceuticals, MAY 7, 2019, View Source;p=RssLanding&cat=news&id=2397477 [SID1234535803]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Bank of America Merrill Lynch 2019 Healthcare Conference in Las Vegas, on Tuesday, May 14 at 3:00 PM PT (6:00 PM ET)
2019 RBC Capital Markets Global Healthcare Conference in New York, on Wednesday, May 22 at 10:30 AM ET
Live audio of the presentations can be accessed by visiting the "Events" page of the company’s website at investor.pacira.com. A replay of the webcasts will also be available for two weeks following the events.

On May 7, 2019 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 first quarter ended March 31, 2019 (Press release, Fate Therapeutics, MAY 7, 2019, View Source [SID1234535827]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"These past several months have been particularly inspiring for the Company, as we have delivered on our multi-year journey to be the first to bring iPSC-derived cell products to patients with cancer. We believe the ability to cost-effectively mass-produce cell-based cancer immunotherapies that can be safely delivered to patients ‘on demand’ in multiple doses has the potential to transform outcomes for many patients, especially when combined with therapeutic agents that have complementary mechanisms of action such as checkpoint inhibitors and monoclonal antibodies," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "We are very encouraged by the initial observations of safety and tolerability from the three patients who received multiple doses of FT500 in the first dose cohort, and we are excited with the initiation of the multi-dose checkpoint inhibitor combination arm where patients have previously progressed or failed therapy. In addition, we continue to make tremendous progress in advancing additional candidates from our off-the-shelf, iPSC-derived NK cell and T-cell product pipeline toward the clinic, and we look forward to generating initial clinical data with FT516 and FT596 in 2019."

Clinical Programs

Landmark Clinical Trial of iPSC-derived Cell Product FT500 Clears Key Safety Hurdle. Three patients with advanced solid tumors have been treated with multiple doses of FT500, the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line, at the first dose level of 100 million cells per dose in the study’s monotherapy arm. All three patients received three once-weekly doses of FT500 in an outpatient setting in the first treatment cycle, which was well-tolerated with no dose-limiting toxicities or serious adverse events reported during the initial 28-day observation period. In accordance with the clinical protocol, all three patients advanced to a second, multi-dose treatment cycle of FT500, which has also been well-tolerated with no dose-limiting toxicities or serious adverse events reported to date. As a result of clearing the first safety hurdle, the Company has commenced patient enrollment at the second dose level of 300 million cells per dose.
FT500 Study Opened for Enrollment in Checkpoint Inhibitor Combination Arm. In April, the Company opened enrollment in the checkpoint inhibitor combination arm of the FT500 clinical trial for the treatment of advanced solid tumors. Multiple doses of FT500 will be administered in combination with either nivolumab, pembrolizumab or atezolizumab in patients whose tumors failed to respond (primary resistance), or progressed following initial response (acquired resistance), with the prior checkpoint inhibitor therapy.
Showcased GMP Manufacturing Data for FT500 Production at ASGCT (Free ASGCT Whitepaper). At the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 22nd Annual Meeting in April, the Company demonstrated its unmatched ability for cGMP mass production of cell-based cancer immunotherapies for off-the-shelf use. Starting with a single cryopreserved vial from the FT500 master iPSC bank, hundreds of cryopreserved doses of FT500 were produced in a single manufacturing campaign at a low cost per dose. The cryopreserved FT500 cell product met stringent post-thaw release specifications, including identity (100% CD45+ hematopoietic cells), purity (98% CD45+CD56+ NK cells), viability and potency, to support shipment to participating clinical sites. FT500 exhibits high levels of expression of key activating receptors (including NKG2D and NKp30/40/46), low levels of expression of checkpoint receptors (including PD-1, LAG-3 and TIGIT), and secretes high levels of cytolytic proteins (such as perforin and granzyme B) in response to challenge with cancer cell lines.
Expanded Enrollment of Phase 2 PROTECT Study of ProTmune to 80 Patients. The randomized, controlled and double-blind Phase 2 PROTECT study has enrolled over 55 patients undergoing allogeneic hematopoietic cell transplant for the treatment of hematologic malignancies. While remaining blinded, the Company has elected to increase the size of the PROTECT study to 80 patients based on strong investigator interest and with the intent to potentially seek regulatory approval of ProTmune using data from the study. The Company expects to complete enrollment of the PROTECT study in 2019 as planned, with data available in 2020 on the study’s primary and secondary endpoints.
Universal, Off-the-Shelf NK and T-cell Cancer Immunotherapy Preclinical Pipeline

Received FDA Clearance of IND Application for First-ever Engineered iPSC-derived Cell Product FT516. In February 2019, the Company announced that the FDA allowed its IND application for FT516, a universal, off-the-shelf NK cell product candidate derived from a clonal master iPSC line engineered to express a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor. FT516 is the first-ever cell product derived from a genetically engineered pluripotent stem cell to be cleared for clinical testing worldwide. A cGMP production run for FT516 has been completed, and final product release testing is ongoing. The Company intends to clinically investigate FT516 for the treatment of relapsed / refractory hematologic malignancies including in combination with certain FDA-approved monoclonal antibody therapies.
Generated Clonal Master Engineered iPSC Bank for FT596 Dual Antigen-targeted CAR NK Cell. FT596 is the Company’s universal, off-the-shelf chimeric antigen receptor (CAR) NK cell product candidate that expresses a proprietary CD19-targeted CAR, a novel hnCD16 Fc receptor for augmented antibody-dependent cellular cytotoxicity (ADCC) and a unique IL-15 receptor fusion for enhanced NK cell activity. The FT596 clonal master iPSC bank was derived from a single iPSC, which was specifically selected based on a series of critical attributes including characterization of the genomic integration sites of the engineered elements, confirmation of genomic stability, demonstration of highly efficient and reproducible production of the product candidate, and robust post-cryopreservation viability and multi-purpose functional activity of the product candidate. The Company expects to submit an IND application to the FDA in mid-2019 for clinical investigation of FT596.
Corporate Highlights

Expanded Board of Directors. In March 2019, the Company appointed Karin Jooss, Ph.D. to its Board of Directors. Dr. Jooss has more than 20 years of experience in oncology and immunology research and development and is currently the Executive Vice President of Research and Chief Scientific Officer of Gritstone Oncology, Inc., a clinical-stage biotechnology company developing next-generation cancer immunotherapies targeting tumor-specific neoantigens.
Expanded Clinical Development and Translation Leadership Team.Sarah Cooley, M.D., M.S. joined the Company in February 2019 as Senior Vice President, Clinical Translation, and Yu-Waye (Wayne) Chu, M.D. joined the Company in April 2019 as Vice President, Clinical Development. Dr. Cooley brings to Fate Therapeutics more than 12 years of leadership in the field of NK cell clinical research and development, having most recently served as Associate Professor of Medicine in the Division of Hematology, Oncology and Transplantation at the University of Minnesota. Dr. Chu brings extensive experience in the development of cancer immunotherapies from Genentech, where he most recently served in Product Development Oncology as global development leader of mosunetuzumab, a full-length T cell-dependent bispecific CD20/CD3 antibody.
First Quarter 2019 Financial Results

Cash & Short-term Investment Position: Cash, cash equivalents and short-term investments as of March 31, 2019 were $183.0 million, compared to $201.0 million as of December 31, 2018. The decrease was primarily driven by the Company’s use of cash to fund operating activities.
Total Revenue: Revenue was $2.6 million for the first quarter of 2019, compared to $1.0 million for the same period in 2018. Revenue was derived from the Company’s collaborations with Ono Pharmaceutical and Juno Therapeutics.
R&D Expenses: Research and development expenses were $17.7 million for the first quarter of 2019, compared to $11.5 million for the same period in 2018. The increase in R&D expenses was primarily attributable to an increase in expenses associated with the preclinical and clinical development of the Company’s product pipeline and in employee compensation, including share-based compensation, associated with growth in headcount.
G&A Expenses: General and administrative expenses were $5.4 million for the first quarter of 2019, compared to $3.6 million for the same period in 2018. The increase in G&A expenses was primarily attributable to an increase in employee compensation, including share-based compensation.
Shares Outstanding: Common shares outstanding were 65.1 million as of March 31, 2019 and 64.7 million as of December 31, 2018. Preferred shares outstanding as of March 31, 2019 and December 31, 2018 were 2.8 million, each of which is convertible into five shares of common stock.
Today’s Conference Call and Webcast
The Company will conduct a conference call today, Tuesday, May 7, 2019 at 5:00 p.m. ET to review financial and operating results for the quarter ended March 31, 2019. In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 6444079. 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 Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (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. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is fraught with batch-to-batch and cell-to-cell variability that can affect safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 100 issued patents and 100 pending patent applications.

About FT500
FT500 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line. Despite the clinical benefit conferred by approved checkpoint inhibitor therapy against a variety of tumor types, these therapies are not curative and, in most cases, patients either fail to respond or progress on these agents. One common mechanism of resistance to checkpoint inhibitor therapy is associated with loss-of-function mutations in genes critical for antigen presentation. A potential strategy to overcome resistance is through the administration of allogeneic NK cells, which have the inherent capability to recognize and directly kill tumor cells with these mutations. FT500 is being investigated in an open-label, multi-dose Phase 1 clinical trial for the treatment of advanced solid tumors (clinicaltrials.gov ID number NCT03841110). The study is designed to assess the safety and activity of three once-weekly doses of FT500 as a monotherapy and in combination with one of three FDA-approved checkpoint inhibitor therapies – nivolumab, pembrolizumab or atezolizumab – in patients that have failed prior checkpoint inhibitor therapy. Patients who are clinically stable following the first cycle of FT500 treatment are eligible to receive a second treatment cycle of three additional once-weekly doses of FT500.

About FT516
FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity (158V), non-cleavable CD16 (hnCD16) Fc receptor. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. CD16 occurs in two variants, either with high (158V) or low (158F) affinity for the Fc domain of IgG1 antibodies. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the CD16 high-affinity variant (approximately 15% of patients) have improved clinical outcomes. In addition, ADCC is dependent on NK cells maintaining active levels of CD16 expression, and the expression of CD16 on NK cells has been shown to undergo considerable down-regulation in cancer patients, which can significantly inhibit anti-tumor activity. FT516 incorporates a novel CD16 Fc receptor, which has been modified to prevent its down-regulation and augment its binding to tumor-targeting antibodies for enhanced ADCC.

About ProTmune
ProTmune is an investigational, first-in-class, allogeneic hematopoietic cell graft for the prevention of acute graft-versus-host disease (GvHD) in patients undergoing hematopoietic cell transplantation (HCT) for the treatment of hematologic malignancies. 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-blind Phase 2 clinical trial in adult subjects with hematologic malignancies undergoing matched unrelated donor HCT.

On May 7, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the Bank of America Merrill Lynch Healthcare Conference on Wednesday, May 15, 2019 (Press release, AbbVie, MAY 7, 2019, View Source [SID1234535844]). Michael Severino, vice chairman and president, will present at 3:00 p.m. Central time.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On May 7, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its first quarter 2019 financial results and provided an update on the company, including its progress in expanding the breadth and depth of the development of IPI-549 in over 500 patients (Press release, Infinity Pharmaceuticals, MAY 7, 2019, View Source [SID1234535860]). IPI-549 is a first-in-class oral immuno-oncology product candidate that targets immune-suppressive tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition. In the first quarter of 2019, Infinity entered into a clinical collaboration with Roche/Genentech moving into front-line triple negative breast cancer (TNBC) and renal cell cancer (RCC) with MARIO-3. In the first quarter of 2019, Infinity also closed the Copiktra royalty monetization for $20.9M in net proceeds and earned a $2M milestone from PellePharm, providing non-dilutive capital to fund the expanded development of IPI-549, including MARIO-3.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Shareholder value creation will be driven by the generation of compelling clinical data with IPI-549, funded with dilution-sensitive capital, and we are pleased to have made important progress on both of these fronts in the first quarter of this year. We continue to advance IPI-549 and remain focused on achieving our key clinical milestones for 2019," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "We are studying IPI-549 in earlier lines of therapy, new indications and novel, potentially transformative immuno-oncology combinations in 2019."

Anticipated Milestones in 2019: Expanding Depth and Breadth of IPI-549 Development

2Q2019

Initiate MARIO-275, a Phase 2 study of IPI-549 in combination with Opdivo, in second-line immuno-oncology (I/O) naïve urothelial cancer patients, in collaboration with BMS
2H2019

Initiate MARIO-3, a Phase 2 study of novel triple combination front-line therapy, in clinical collaboration with Roche/Genentech:
IPI-549 in combination with Tecentriq and Abraxane in TNBC
IPI-549 in combination with Tecentriq and Avastin in RCC
Complete enrollment of MARIO-1 combination expansion cohorts including:
Augmented melanoma expansion cohort (n=40)
TNBC expansion cohort (n=29)
Advance into novel triple combination therapies beyond checkpoint inhibitors: initiate triple therapy (IPI-549+AB928+Abraxane) in previously treated advanced TNBC in collaboration with Arcus Biosciences
First Quarter 2019 Financial Results

At March 31, 2019, Infinity had total cash, cash equivalents and available-for-sale securities of $70.5 million, compared to $58.6 million at December 31, 2018.
Infinity recognized the $30 million gross proceeds from the Copiktra royalty monetization as a liability, net of transaction costs, as of March 31, 2019. We are amortizing the liability to non-cash interest expense, and we will continue to recognize the royalty revenue that Verastem pays to HealthCare Royalty Partners III, L.P. (HCR) as non-cash royalty revenue. We shared 25% of the proceeds, net of expenses, under the HCR agreement with Takeda. In addition, we will pay to Takeda 25% of royalties that, but for the HCR agreement, would have been payable to us by Verastem during the term of the HCR agreement.
Revenue during the first quarter of 2019 was $2.1 million, which primarily relates to the achievement of a $2.0 million milestone from PellePharm for the initiation of a Phase 3 study investigating patidegib (a hedgehog pathway inhibitor) in patients with Gorlin Syndrome. We did not have any revenue for the same period in 2018.
R&D expense for the first quarter of 2019 was $5.8 million, compared to $5.9 million for the same period in 2018.
General and administrative expense was $3.4 million for the first quarter 2019, compared to $3.6 million for the same period in 2018.
Royalty expense for the first quarter of 2019 was $6.8 million, which primarily relates to our payment to Takeda in relation to the monetization of Copiktra royalties.
Net loss for the first quarter of 2019 was $13.7 million, or a basic and diluted loss per common share of $0.24, compared to a net loss of $9.5 million, or a basic and diluted loss per common share of $0.18 for the same period in 2018.
2019 Updated Financial Guidance

Net Loss: Infinity expects net loss for 2019 to range from $40 million to $50 million including the Copiktra royalty monetization.
Cash and Investments: Infinity expects to end 2019 with a year-end cash, cash equivalents and available-for-sale securities balance ranging from $40 million to $50 million including the Copiktra royalty monetization.
Cash Runway: Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities will be adequate to satisfy the company’s capital needs into 2H 2020. Infinity’s financial guidance excludes additional funding or business development activities and excludes the potential monetization of future milestones and/or royalties payments from PellePharm, a private company, to whom Infinity licensed patidegib in 2013.
Conference Call Information

Infinity will host a conference call today, May 7, 2019, at 4:30 p.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) and 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 5779562. An archived version of the webcast will be available on Infinity’s website for 30 days.

About Infinity and IPI-549

Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is advancing IPI-549, a first-in-class, oral immuno-oncology development candidate that selectively inhibits PI3K-gamma, in multiple clinical studies. MARIO-1 is an ongoing Phase 1/1b study evaluating IPI-549 as a monotherapy and in combination with Opdivo (nivolumab) in approximately 220 patients with advanced solid tumors including patients refractory to anti-PD-1 therapy. Infinity intends to initiate MARIO-275, a global, randomized, combination study of IPI-549 combined with Opdivo in I/O naïve urothelial cancer patients in 2Q19, as well as to initiate MARIO-3, the first IPI-549 combination study in front-line advanced cancer patients in 2H19. MARIO-3 will evaluate IPI-549 in combination with Tecentriq and Abraxane in front-line TNBC and in combination with Tecentriq and Avastin in front-line RCC. With the addition of MARIO-275 and MARIO-3 to the ongoing MARIO-1 study, Infinity will be evaluating IPI-549 in the anti-PD-1 refractory, I/O-naïve and front-line settings in a total of ~500 patients. For more information on Infinity, please refer to Infinity’s website at www.infi.com.