On May 4, 2018 Delcath Systems, Inc. (OTCQB:DCTHD), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported that Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath, will present at the RHK Capital 2018 Disruptive Growth and Healthcare Conference being held May 8-9, 2018 at Reed Smith, LLP in New York. Dr. Simpson’s presentation details are as follows (Press release, Delcath Systems, MAY 4, 2018, View Source;p=RssLanding&cat=news&id=2347110 [SID1234526133]):

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Panel Presentation:

Session: Disruptive Injectables & Oncology
Date and Time: Tuesday, May 8 at 1:45-2:45 p.m. EST
Location: Track 2 – Room C/D
Corporate Presentation:

Date and Time: Tuesday, May 8 at 3:25-3:45 p.m. EST
Location: Room A/B

On May 4, 2018 Cotinga Pharmaceuticals Inc. (TSX Venture:COT) (OTCQB:COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported the closing of a brokered private placement (the "Brokered Offering") and a non-brokered private placement (the "Non-Brokered Offering", and together with the Brokered Offering, the "Offering") for total proceeds of approximately CAD $2,010,000 (Press release, Cotinga, MAY 4, 2018, View Source [SID1234533155]). Pursuant to the Offering, the Company issued 5,289,900 units (the "Units") at a price of CAD $0.38 per Unit. Cotinga plans to use the net proceeds from the Offering to support the continued clinical development of COTI-2.

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"This private placement improves our balance sheet and provides the funds necessary to advance our lead asset, COTI-2, into clinical development as a combination therapy," said Alison Silva, President and CEO. "Specifically, these funds enable us to expand our ongoing Phase 1 trial to evaluate COTI-2 in combination with various standards-of-care in a wide spectrum of cancers. We expect to provide a clinical update on these efforts in the months ahead. This financing also allowed us to diversify our shareholder base as we were pleased to secure U.S.-based institutional support to lead the offering. We welcome our new investors, who comprised 65% of this round, into the Cotinga story. We remain confident advancing COTI-2 will be a meaningful value-driver for both patients and shareholders, and we thank all of our shareholders for their continued support."

Each Unit consisted of one common share of the Company (each, a "Common Share") and one Common Share purchase warrant (each, a "Warrant") of the Company. Each Warrant is exercisable for one Common Share (each, a "Warrant Share") at an exercise price of CAD $0.47 per Common Share for a period of 60 months from May 3, 2018 (the "Closing Date"). The Common Shares and Warrants issued by the Company pursuant to the Offering are subject to restrictions on resale in accordance with applicable Canadian and U.S. securities laws and the policies of the TSX Venture Exchange (the "TSXV"). Under Canadian securities laws, the Common Shares, Warrants and Warrant Shares are subject to a restriction on resale for a period of four months plus one day from the Closing Date. Certain U.S. subscribers have been granted the right to participate in an aggregate of up to 50% of any subsequent financing of the Company for a period of 12 months from the Closing Date. The Offering is subject to final acceptance of the TSXV.

Roth Capital Partners, LLC (the "Agent") acted as sole placement agent for the Brokered Offering in the United States. The Agent received: (i) a cash commission of CAD $89,775; (ii) 158,697 warrants to purchase Common Shares exercisable for a period of 60 months from the Closing Date at an exercise price of CAD $0.47 per Common Share; and (iii) a corporate finance fee of CAD $50,936.

Certain registered dealers and other persons qualified to receive a finder’s fee ("Finders") received, in relation to the Non-Brokered Offering: (i) a cash commission of CAD $10,260; and (ii) 27,000 warrants to purchase Common Shares exercisable for a period of 60 months from the Closing Date at an exercise price equal to CAD $0.47 per Common Share.

The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the U.S. registration requirements. This news release does not constitute an offer for Press Release sale of securities or a solicitation for offers to buy any securities. Any public offering of securities in the United States must be made by means of a prospectus containing detailed information about the company and management, as well as financial statements.

On May 4, 2018 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, is hosting an Investor Day in New York City today. During the event, reported that the company will provide a comprehensive business update and report financial results for the first quarter ended March 31, 2018 (Press release, Agios Pharmaceuticals, MAY 4, 2018, View Source [SID1234526111]). The presentations will highlight how Agios’ drug discovery platform and broad clinical portfolio set Agios on the path to become a sustainable, multi-product biopharmaceutical company. The event will be webcast today starting at 8:00 a.m. ET at investor.agios.com.

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"As we prepare to launch our second Agios-discovered and first wholly owned medicine later this year, we continue to invest in our productive drug discovery engine and advance a robust pipeline of first-in-class medicines," said David Schenkein, M.D., chief executive officer at Agios. "Our first quarter progress against that objective was highlighted by the NDA acceptance of TIBSOVO in IDH1m relapsed or refractory AML and multiple clinical trial initiations, including dosing the first patient with our MAT2A inhibitor AG-270 and the start of our AG-348 pivotal program in PK deficiency."

HIGHLIGHTS FROM INVESTOR DAY PRESENTATIONS

• Communicated a robust research pipeline consisting of nine advanced drug discovery programs against novel targets across oncology, rare genetic diseases and metabolic immuno-oncology with the potential to deliver multiple INDs over the next 24 months.

• Expanded rare genetic disease portfolio:

• The company disclosed active research programs in three rare genetic diseases: phenylketonuria (PKU), erythroid porphyria and Friedreich’s ataxia
LOGO

• The most advanced research program is in PKU, where Agios has developed a novel approach to stabilize the mutant phenylalanine hydroxylase (PAH) protein and has demonstrated significantly decreased blood phenylalanine levels in a severe pre-clinical model of the disease. PKU is an autosomal recessive disease caused by mutations in the PAH gene affecting approximately 16,000 patients in the U.S.1

• Updated clinical milestones to advance the development of isocitrate dehydrogenase (IDH) 1 inhibitors in solid tumors:

• Glioma pivotal development strategy expected to be finalized by year-end 2018

• Completion of enrollment of ClarIDHy, a global, registration-enabling randomized Phase 3 study for ivosidenib in IDH1m positive advanced cholangiocarcinoma, accelerated to the first half of 2019

• Announced acceptance of the following presentations at 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting:

• Updated data from the expansion phase of the ongoing Phase 1 study of ivosidenib in IDH1m relapsed or refractory (R/R) acute myeloid leukemia (AML)

• Updated data from the ongoing Phase 1/2 combination trial of enasidenib or ivosidenib with VIDAZA in patients with newly diagnosed AML with an IDH2 or IDH1 mutation ineligible for intensive chemotherapy

• First clinical data from the Phase 1 study of AG-881 in advanced IDHm positive solid tumors, including glioma

• Completed commercial infrastructure build, including the deployment of an expanded sales force, to successfully launch TIBSOVO (ivosidenib) within 48 hours of potential FDA approval.
FIRST QUARTER 2018 HIGHLIGHTS & RECENT PROGRESS

• Initiated ACTIVATE-T, a single-arm pivotal trial for AG-348, in adult pyruvate kinase (PK) deficiency patients who receive regular blood transfusions.

• Initiated PEAK, a global registry, for adult and pediatric patients with PK deficiency.

• Initiated a perioperative ‘window’ trial with ivosidenib and AG-881 in IDHm low-grade glioma to further investigate their effects on brain tumor tissue.

• Initiated a Phase 1 dose-escalation trial for AG-270, a first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor, in patients with methylthioadenosine phosphorylase (MTAP)-deleted tumors.

• Announced FDA acceptance, priority review and a Prescription Drug User Fee Act (PDUFA) action date of August 21, 2018 for the new drug application (NDA) for TIBSOVO (ivosidenib) for the treatment of patients with R/R AML with an IDH1 mutation.

• Completed an underwritten public offering of 8,152,986 shares of common stock at the offering price of $67.00 per share, resulting in proceeds to the company, net of underwriting discounts and commissions, of approximately $516.2 million.
LOGO

UPCOMING 2018 MILESTONES & EXPECTED DATA PRESENTATIONS

The company expects to achieve the following additional milestones in 2018:

Cancer:

Potential approval and commercialization of TIBSOVO (ivosidenib) in the United States for R/R AML with an IDH1 mutation in the third quarter of 2018.

Submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for TIBSOVO (ivosidenib) for the treatment of patients with R/R AML and an IDH1 mutation in the fourth quarter of 2018.

Support, in collaboration with Celgene, the initiation of HO150, an intergroup sponsored, global, registration-enabling Phase 3 trial combining ivosidenib or enasidenib with standard induction and consolidation chemotherapy in frontline AML patients with an IDH1 or IDH2 mutation in the fourth quarter of 2018.

Present updated data from the ongoing Phase 1 combination trial of enasidenib or ivosidenib with standard-of-care intensive chemotherapy in patients with newly diagnosed AML with an IDH2 or IDH1 mutation to the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.
Rare Genetic Diseases:

Initiate ACTIVATE, a global, placebo-controlled, pivotal trial for AG-348 in approximately 80 adults with PK deficiency who do not receive regular blood transfusions in the second quarter of 2018.

Initiate a Phase 2 proof of concept trial of AG-348 in thalassemia in the fourth quarter of 2018.
Research:

Submit an investigational new drug (IND) application for our newest development candidate, AG-636, an inhibitor of the metabolic enzyme dihydroorotate dehydrogenase (DHODH) for the treatment of hematologic malignancies in the fourth quarter of 2018.
FIRST QUARTER 2018 FINANCIAL RESULTS & CASH GUIDANCE

Revenue for the quarter ended March 31, 2018 was $8.8 million, which includes $7.4 million of collaboration revenue and $1.4 million of royalty revenue from net sales of IDHIFA. Revenue for the quarter ended March 31, 2017 was $10.5 million and consisted solely of collaboration revenue. The decrease in collaboration revenue recognized for the quarter ended March 31, 2018 compared to the comparable period in 2017 was primarily driven by adoption of the new revenue recognition standard.

Research and development (R&D) expenses were $78.2 million, including $8.6 million of stock-based compensation expense, for the quarter ended March 31, 2018, compared to $62.7 million, including $7.0 million in stock-based compensation expense, for the comparable period in 2017. The increase in R&D expense was primarily attributable to start-up costs for the AG-348 pivotal program in PK deficiency, including the initiation of the ACTIVATE-T trial. R&D expense also increased as a result of the initiation of a Phase 1 dose-escalation study of AG-270, our first-in-class MAT2A inhibitor, and IND enabling activities for AG-636, our DHODH inhibitor.

General and administrative (G&A) expenses were $24.6 million, including $5.9 million of stock-based compensation expense, for the quarter ended March 31, 2018, compared to $14.8 million, including $3.7 million of stock-based compensation expense, for the quarter ended March 31, 2017. The increase in G&A expense was primarily attributable to the growth in our U.S. commercial organization in order to support the expected launch of TIBSOVO (ivosidenib) in the third quarter of 2018.

Net loss for the quarter ended March 31, 2018 was $90.8 million, compared to a net loss of $66.2 million for the quarter ended March 31, 2017.

Cash, cash equivalents and marketable securities as of March 31, 2018 were $994.7 million, compared to $567.8 million as of December 31, 2017. The increase in cash was driven by the net proceeds of $516.2 million from the January follow on offering, $4.4 million of cost reimbursements under our collaboration agreements with Celgene and $12.3 million received from employee stock transactions. This was offset by expenditures to fund operations of $104.8 million during the quarter ended March 31, 2018.

The company expects that its cash, cash equivalents and marketable securities as of March 31, 2018, together with the anticipated product and royalty revenue, anticipated interest income, and anticipated expense reimbursements, but excluding any additional program-specific milestone payments, will enable the company to fund its anticipated operating expenses and capital expenditure requirements through at least the end of 2020.

WEBCAST INFORMATION

The live webcast from today’s event can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website after the event.

On May 4, 2018 DXC Technology (NYSE: DXC), the world’s leading independent, end-to-end IT services company, reported that it will release financial results for the fourth quarter and full year fiscal 2018 on Thursday, May 24, 2018, at approximately 4:15 p.m. Eastern Daylight Time (EDT) (Press release, DynPort Vaccine Company, MAY 4, 2018, View Source [SID1234526134]).

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DXC Technology senior management will host a conference call and webcast on the same day at 5 p.m. EDT. The dial-in number for domestic callers is (800) 289-0438. Callers who reside outside of the United States should dial +1 (323) 794-2423. The passcode for all participants is 6166236. The webcast audio and any presentation slides will be available on DXC Technology’s Investor Relations website.

A replay of the conference call will be available from approximately two hours after the conclusion of the call until May 31, 2018. Replay numbers can be found at the following link. The replay passcode is also 6166236.

On May 4, 2018 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported operating results for the quarter ended March 31, 2018 (Press release, ImmunoGen, MAY 4, 2018, View Source [SID1234526112]).

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"We have achieved a number of important milestones to start the year, led by the advancement of mirvetuximab soravtansine," said Mark Enyedy, ImmunoGen’s president and chief executive officer. "Our FORWARD I registration trial continues as planned following the successful outcome of the pre-specified interim futility analysis and the completion of enrollment in the trial earlier than expected. This accelerated accrual reflects the significant interest expressed by the oncology community in mirvetuximab and the need for new treatments in platinum-resistant ovarian cancer. In addition, as we look to expand the eligible patient population for this program, we were also pleased to report encouraging data for mirvetuximab in combination with Keytruda from our FORWARD II trial at SGO in March and look forward to presenting additional data from FORWARD II during 2018, with a poster presentation at ASCO (Free ASCO Whitepaper) for the mirvetuximab and Avastin expansion cohort. Finally, with our continued evolution towards a commercial-stage company, we have strengthened our management team with the addition of Blaine McKee as Chief Business Officer."

Recent Progress

Mirvetuximab Soravtansine

· In April, ImmunoGen announced the completion of patient enrollment two months ahead of schedule in its Phase 3 FORWARD I trial. FORWARD I is designed to support full approval of mirvetuximab as a single-agent therapy for platinum-resistant ovarian cancer.

· In April, ImmunoGen successfully completed a pre-specified interim analysis for futility after 80 progression-free survival (PFS) events in FORWARD I. The study will continue

as planned based on the recommendation of the Independent Data Monitoring Committee and the Company is on-track to report top-line results in first half of 2019.

·In March, ImmunoGen presented data from the dose-escalation FORWARD II cohort evaluating mirvetuximab in combination with Keytruda (pembrolizumab) at the Society of Gynecologic Oncology (SGO) Annual Meeting, demonstrating encouraging efficacy and favorable tolerability in patients with platinum-resistant ovarian cancer. Notably, in the subset of eight patients with medium or high levels of folate receptor alpha (FRα) expression, the confirmed overall response rate (ORR) was 63 percent (95% CI 25, 92), with a median PFS of 8.6 months (95% CI 1.6, upper bound not yet reached), and duration of response of 36.1 weeks. Based on these data, ImmunoGen is enrolling an additional 35 patients with medium or high FRα expression levels in an expansion cohort in the FORWARD II study and expects to present data from this cohort later this year.

Early-Stage Pipeline — Novel IGN Compounds

· IMGN779 is a CD33-targeting ADC in a Phase 1 dose-finding study in relapsed/refractory acute myeloid leukemia (AML). Dose escalation is continuing with both biweekly and weekly dosing schedules. The Food and Drug Administration (FDA) has granted orphan-drug designation to IMGN779 for the treatment of AM

IMGN632 is a CD123-targeting ADC in a Phase 1 dose-finding study for AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Research and Innovation
In April, ImmunoGen presented three posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting highlighting the Company’s ongoing innovation in ADCs, including advancements to payloads and targets for enhanced anti-tumor activity as well as insights into factors that determine the clinical efficacy of ADCs.

Anticipated Upcoming Events

Report updated data from the FORWARD II mirvetuximab plus Avastin (bevacizumab) combination expansion cohort in approximately 50 patients at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting;

· Anticipate partner Takeda to begin clinical testing of TAK-164 in 2Q 2018;

· Report initial findings from the FORWARD II mirvetuximab plus pembrolizumab combination expansion cohort in 35 patients in the second half of the year;

· Report additional data from IMGN779 Phase 1 dose finding study in 4Q 2018 and identify the recommended Phase 2 dose before the end of the year;

· Report initial data from IMGN632 Phase 1 dose finding study in 4Q 2018; and

· Advance ADAM9 program into IND-enabling activities before year-end.

Financial Results

Revenues for the quarter ended March 31, 2018 were $19.8 million, compared to $28.5 million for the quarter ended March 31, 2017. License and milestone fees of $11.5 million for the first quarter of 2018 included $10.9 million and $0.5 million of recognized upfront fees previously received from Takeda and Debiopharm, respectively, compared to recognition of $12.7 million

of a non-cash fee related to the Company’s license agreement with CytomX and $6 million in partner milestone payments received in the first quarter of 2017. Revenues in the first quarter of 2018 included $7.2 million in non-cash royalty revenues, compared with $7.6 million for the same quarter in 2017, reflecting a change in accounting standards for recognizing royalty revenue. Revenues for the first quarter of 2018 also included $0.4 million of research and development (R&D) support fees and $0.7 million of clinical materials revenue, compared with $1.5 million and $0.7 million, respectively, for the same quarter in 2017.

Operating expenses, including R&D and G&A expenses, for the first quarter of 2018 were $56.6 million, compared to $41.4 million for the same quarter in 2017. R&D expenses for the first quarter of 2018 increased to $44.8 million, compared to $32.9 million for the first quarter of 2017, primarily due to increased clinical trial and drug supply costs driven largely by the accelerated timing of completing patient enrollment in the FORWARD I Phase 3 clinical trial. General and administrative expenses increased in the first quarter of 2018 to $10.0 million, compared to $8.1 million in the same quarter of 2017, primarily due to increased third-party service fees and stock-based compensation. Operating expenses for the first quarter of 2018 also included a $1.7 million restructuring charge due to the workforce reduction related to the decommissioning of our Norwood facility as previously announced by the Company, compared to a $0.4 million charge in the same quarter of 2017 related to losses recorded on leased office space in Waltham.

ImmunoGen reported a net loss of $38.6 million, or $0.30 per basic and diluted share, for the first quarter of 2018, compared to a net loss of $17.3 million, or $0.20 per basic and diluted share, for the same quarter last year.

ImmunoGen had $218.4 million in cash and cash equivalents as of March 31, 2018, compared with $267.1 million as of December 31, 2017, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $50.0 million for the first quarter of 2018, compared with $33.0 million for the first quarter of 2017. Capital expenditures were $1.0 million and $0.4 million for the first quarter of 2018 and 2017, respectively.

Financial Guidance

ImmunoGen has updated its operating expenses guidance for 2018. ImmunoGen now expects:

operating expenses between $200 million and $205 million.

Guidance for revenues and cash remains unchanged:

revenues between $60 million and $65 million; and

cash and cash equivalents at December 31, 2018 between $115 million and $120 million.

ImmunoGen expects that its current cash combined with the expected cash revenues from partners and collaborators will enable the Company to fund its operations into the fourth quarter of 2019.

Conference Call Information
ImmunoGen will hold a conference call today at 8:00 am ET to discuss these results. To access the live call by phone, dial 719-325-4799; the conference ID is 2070974. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through May 18, 2018.