On May 8, 2018 Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) ("Valeant" or the "Company" or "we") reported its first-quarter 2018 financial results (Press release, Valeant, MAY 8, 2018, http://ir.valeant.com/news-releases/2018/05-08-2018-120156169 [SID1234526270]).

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"Our first-quarter 2018 results demonstrate that we are making significant progress in our turnaround. For the first time since 2015, the Company delivered overall organic revenue growth2 that tracked above expectations and was driven by our Branded Rx and Bausch + Lomb/International segments," said Joseph C. Papa, chairman and CEO, Valeant. "As a result, we are raising our full-year revenue and Adjusted EBITDA (non-GAAP) guidance ranges to reflect our strong performance in the first quarter."

Company Highlights

Executing on Core Businesses and Advancing Pipeline

Reported revenue in the Bausch + Lomb/International segment decreased by 3% compared to the first quarter of 2017 primarily due to divestitures and discontinuations; revenue in this segment grew organically2 by 2% compared to the first quarter of 2017
Grew revenue in the Global Vision Care business by 15% compared to the first quarter of 2017; revenue in this business grew organically2 by 9% compared to the first quarter of 2017
Grew revenue in the aggregate in China by 24% compared to the first quarter of 2017; revenue in this business grew organically2 by 15% compared to the first quarter of 2017
Launches underway for additional two of the "Significant Seven" products, including:
VYZULTA, a treatment option for glaucoma
LUMIFY, the only over-the-counter eye drop with low-dose brimonidine for the treatment of eye redness
Reported revenue in the Branded Rx segment decreased by 6% compared to the first quarter of 2017 primarily due to divestitures and discontinuations, and declines in the Ortho Dermatologics business; revenue in this segment grew organically2 by 8% compared to the first quarter of 2017
Grew revenue in the Salix business by 40% compared to the first quarter of 2017
XIFAXAN revenue increased by 49% compared to the first quarter of 2017
RELISTOR franchise revenue increased by 54% compared to the first quarter of 2017
APRISO revenue increased by 31% compared to the first quarter of 2017
UCERIS franchise revenue increased by 27% compared to the first quarter of 2017
The U.S. Food and Drug Administration (FDA) approved PLENVU, a 1-liter bowel cleansing preparation for colonoscopies, which is expected to be available in the third quarter of 2018
Continued to stabilize the Ortho Dermatologics business
Increased dermatology sales force by approximately 25% in January 2018
Expanded the SILIQ launch after executing REMS certifications for more than 2,500 physicians, which includes more than 50% of the target prescribers
Launched RETIN-A MICRO 0.06% topical treatment for acne in January 2018 with sales tracking above the Company’s expectations
The FDA accepted New Drug Applications for:
ALTRENO3 (IDP-121), an acne treatment in lotion form; PDUFA action date of Aug. 27, 2018
BRYHALI3 (IDP-122), a topical treatment for plaque psoriasis; PDUFA action date of Oct. 5, 2018
Pivotal efficacy and safety data for DUOBRII3 (IDP-118), a topical treatment for plaque psoriasis, was published in The Journal of the American Academy of Dermatology
Completed Phase 2 studies for IDP-120, a topical treatment for acne that contains a fixed dose combination of tretinoin and benzoyl peroxide gel; Phase 3 studies are expected to begin in the second half of 2018
Entered into an exclusive licensing agreement with Kaken Pharmaceutical Co., Ltd. to develop and commercialize products containing a new chemical entity that, if approved, would represent a novel drug with an alternate mechanism of action in the topical treatment of psoriasis
Reducing Debt and Extending Maturities

Repaid approximately $280 million of debt with cash on hand in the first quarter of 2018
Repaid $200 million of the Company’s senior secured term loans, using cash on hand, in January 2018
Redeemed remaining $71 million aggregate principal amount of our outstanding 7.000% Senior Unsecured Notes due 2020, using cash on hand, on March 30, 2018
Issued $1.5 billion aggregate principal amount of 9.250% senior notes due 2026 on March 26, 2018
Used net proceeds, along with cash on hand, to repurchase, through cash tender offers, approximately $1.45 billion aggregate principal amount of outstanding Senior Notes due 2020 and 2021, and to pay fees and expenses
Resolving Legal Issues

Achieved dismissals or other positive outcomes in resolving and managing litigation and investigations in approximately 20 matters since Jan. 1, 2018
The UCERISarbitration was decided in favor of Valeant with the Arbitral Tribunal issuing a ruling that rejected the other party’s claims and ordering that they pay the entirety of Valeant’s legal costs
Agreed to resolve the SOLODYNantitrust litigations, with the class settlement ($58 million) being subject to final court approval
Agreed to resolve California Department of Insurance matter relating to Philidor, with no finding of admission or liability by Valeant
Summary judgment granted that upheld validity of RELISTOR Injection patent, U.S. Patent No. 8,552,025, preventing generic competition until 2024
First-Quarter 2018 Revenue Performance
Total reported revenues were $1.995 billion for the first quarter of 2018, as compared to $2.109 billion in the first quarter of 2017, a decrease of $114 million, or 5%. Excluding the impact of the 2017 divestitures and discontinuations of $214 million and the favorable impact of foreign exchange of $66 million, revenue grew organically2 by 2% compared to the first quarter of 2017, primarily driven by growth in the Salix business and the Bausch + Lomb/International segment. Organic2 revenue growth was partially offset by declines in the Ortho Dermatologics business and lower volumes in the U.S. Diversified Products segment, attributed to the previously reported loss of exclusivity for a basket of products.

Bausch + Lomb/International Segment
Bausch + Lomb/International segment revenues were $1.103 billion for the first quarter of 2018, as compared to $1.134 billion for the first quarter of 2017, a decrease of $31 million, or 3%. Excluding the impact of divestitures and discontinuations of $113 million, and the favorable impact of foreign exchange of $65 million, the Bausch + Lomb/International segment grew organically2 by approximately 2% compared to the first quarter of 2017.

Branded Rx Segment
Branded Rx segment revenues were $593 million for the first quarter of 2018, as compared to $629 million for the first quarter of 2017, a decrease of $36 million, or 6%. Excluding the impact of divestitures and discontinuations of $83 million and the favorable impact of foreign exchange of $1 million, the Branded Rx segment grew organically2 by approximately 8% compared to the first quarter of 2017. Compared to the first quarter of 2017, the Salix business grew revenue by 40%, largely driven by sales growth in XIFAXAN and other promoted products.

U.S. Diversified Products Segment
U.S. Diversified Products segment revenues were $299 million for the first quarter of 2018, as compared to $346 million for the first quarter of 2017, a decrease of $47 million, or 14%. The decline was primarily driven by decreases attributed to the previously reported loss of exclusivity for a basket of products and by the impact of the 2017 divestitures and discontinuations of $18 million.

Operating Loss
Operating loss was $2.281 billion for the first quarter of 2018, as compared to an operating income of $211 million for the first quarter of 2017, a decrease of $2.492 billion. The decrease in operating results for the first quarter of 2018 primarily reflects goodwill impairment charges of $2.213 billion related to the Salix and Ortho Dermatologics businesses. These charges were recognized when the Company adopted new accounting guidance from the Financial Accounting Standards Board in January 2018.

Net Loss
Net loss for the three months ended March 31, 2018 was $2.693 billion, as compared to net income of $628 million for the same period in 2017, a decrease of $3.321 billion. The decrease in net income is primarily attributed to a decrease in the benefit from income taxes and the goodwill impairment charges recorded in the first quarter of 2018. Net income in the first quarter of 2017 included an income tax benefit of $908 million from a non-cash internal restructuring in that quarter.

Adjusted net income (non-GAAP) for the first quarter of 2018 was $312 million, as compared to $273 million for the first quarter of 2017, an increase of 14%.

Operating Cash
The Company delivered $438 million in operating cash in the first quarter of 2018, which was above expectations due to reductions in working capital and despite settlement payments of $170 million that were made in the first quarter for certain legacy legal matters, including the SOLODYN Antitrust Class Actions and Allergan Shareholder Class Actions.

Cash flow in the first quarter of 2018 decreased by $516 million, as compared to $954 million in the first quarter of 2017. The first quarter of 2017 included a one-time cash receipt attributed to our fulfillment agreement with Walgreens.

EPS
GAAP Earnings Per Share (EPS) Diluted for the first quarter of 2018 was $(7.68), as compared to $1.79 for the first quarter of 2017.

Adjusted EBITDA(non-GAAP)
Adjusted EBITDA (non-GAAP) was $832 million for the first quarter of 2018, as compared to $861 million for the first quarter of 2017, a decrease of $29 million, primarily driven by the impact of the 2017 divestitures of $75 million, offset by growth in the Salix business.

2018 Financial Outlook
Valeant has raised guidance for the full year of 2018 and has not changed anticipated dates for products losing exclusivity (LOE) later this year:

Full-Year Revenues in the range of $8.15 – $8.35 billion from $8.10 – $8.30 billion
Full-Year Adjusted EBITDA (non-GAAP) in the range of $3.15 – $3.30 billion from $3.05 – $3.20 billion
Other than with respect to GAAP Revenues, the Company only provides guidance on a non-GAAP basis. The Company does not provide a reconciliation of forward-looking Adjusted EBITDA (non-GAAP) to GAAP net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. In periods where significant acquisitions or divestitures are not expected, the Company believes it might have a basis for forecasting the GAAP equivalent for certain costs, such as amortization, which would otherwise be treated as non-GAAP to calculate projected GAAP net income (loss). However, because other deductions (such as restructuring, gain or loss on extinguishment of debt and litigation and other matters) used to calculate projected net income (loss) vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amount of these deductions may be material and, therefore, could result in projected GAAP net income (loss) being materially less than projected Adjusted EBITDA (non-GAAP). The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-looking Statements section of this news release.

Additional Highlights

Valeant’s cash and cash equivalents were $909 million at March 31, 2018
The Company’s availability under the Revolving Credit Facility was approximately $1.1 billion at March 31, 2018
Conference Call Details

Date:

Tuesday, May 8, 2018

Time:

8:00 a.m. EDT

Web cast:

http://ir.valeant.com/events-and-presentations

Participant Event Dial-in:

(844) 428-3520 (North America)

(409) 767-8386 (International)

Participant Passcode:

6185877

Replay Dial-in:

(855) 859-2056 (North America)

(404) 537-3406 (International)

Replay Passcode:

6185877 (replay available until July 8, 2018)

On May 8, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new data from its early and late-stage clinical studies, on more than 19 approved and investigational cancer medicines, will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from 1-5 June, in Chicago, IL, United States (Press release, Hoffmann-La Roche, MAY 8, 2018, View Source [SID1234526184]). More than 180 abstracts have been accepted across 13 cancer types, including two "late breakers" and 15 oral presentations.

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"New data to be presented from our industry-leading oncology portfolio, including our lung and haematology programmes, will demonstrate how our science-driven approach aims to improve outcomes for people living with cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "At ASCO (Free ASCO Whitepaper), we look forward to sharing our progress and commitment to build the future of personalised healthcare in oncology."

Further information on Roche’s contribution to the ASCO (Free ASCO Whitepaper) 2018 scientific programme, as well as Roche’s wider progress in cancer care, will be featured during the Roche Media Briefing from 09:00 – 10:45 CDT on Friday, 1 June at the Chicago Marriott Downtown Magnificent Mile, Chicago, IL, US. This event, independently organised by Roche, is open to journalists from outside the United States who have registered as media with the ASCO (Free ASCO Whitepaper) 2018 Annual Meeting. To register for the Roche Media Briefing, please follow this link: https://roche.cvent.com/d/6gq8k1/.

Follow Roche on Twitter via @Roche and keep up to date with ASCO (Free ASCO Whitepaper) 2018 congress news and updates by using the hashtag #ASCO18.

Key presentations in lung cancer
Key data to be presented at ASCO (Free ASCO Whitepaper) cover advances from Roche’s lung cancer programme, including a combination approach using the cancer immunotherapy, Tecentriq (atezolizumab) with targeted therapies and a range of different chemotherapies.

Updated OS data and new patient reported outcomes (PROs) data from the Phase III IMpower150 study of Tecentriq plus Avastin (bevacizumab) and chemotherapy (carboplatin and paclitaxel), in people with previously-untreated, advanced non-squamous non-small cell lung cancer (NSCLC), will be presented. The US Food and Drug Administration (FDA) recently granted Priority Review for this combination in the same patient population.

New PFS results from the Phase III IMpower131 study of Tecentriq plus chemotherapy (carboplatin and Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) as an initial (first-line) treatment for people with advanced squamous NSCLC will also be shared and feature as part of ASCO (Free ASCO Whitepaper)’s official press programme on Saturday, 2 June.

Additional results in lung cancer include longer follow-up results from the Phase III ALEX study of Alecensa (alectinib) versus crizotinib in people with previously untreated anaplastic lymphoma kinase (ALK)-positive NSCLC. These data build on the primary results from the ALEX study, first presented at ASCO (Free ASCO Whitepaper) 2017, which demonstrated a significant reduction in the risk of disease progression or death versus crizotinib. New data that utilise the application of a real world endpoint to identify and characterise genetic profiles of people with a poor prognosis in advanced NSCLC will also be presented at the congress.

Additional presentations with cancer immunotherapy
Additional cancer immunotherapy data presentations of note include new Tecentriq plus Avastin PROs from the Phase III IMmotion151 study in advanced renal cell carcinoma (RCC), and Phase Ib data for the combination of Tecentriq plus Avastin in first-line hepatocellular carcinoma (HCC). These studies add to the growing body of evidence that support the use of Tecentriq plus Avastin across multiple tumour types.

New tumour mutational burden (TMB) data from two studies of Tecentriq will also be presented, including blood-based TMB data from the Phase II B-F1RST study in advanced NSCLC, and tissue-based TMB data across multiple tumour types including NSCLC, metastatic urothelial carcinoma and melanoma.

Key presentations in blood cancers
Data from pivotal studies in haematology will also be presented at ASCO (Free ASCO Whitepaper). Additional analyses on minimal residual disease (MRD) rates will be shared from the Phase III MURANO study evaluating Venclexta/Venclyxto (venetoclax) plus MabThera/Rituxan (rituximab), compared to bendamustine plus MabThera/Rituxan, in people with relapsed or refractory chronic lymphocytic leukaemia (CLL). A supplemental new drug application (sNDA) based on the MURANO data was granted Priority Review by the FDA, with an action date of 28 June 2018.

Additional data will also be presented from the Phase Ib M14-358 study of Venclexta/Venclyxto plus azacitidine or decitabine in people with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. Venclexta/Venclyxto is being developed by AbbVie and Roche.

Data from the randomised Phase II study evaluating polatuzumab vedotin in combination with bendamustine chemotherapy and MabThera/Rituxan in people with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) will also be presented at the meeting.

Key presentations in breast cancer
Updates from two investigational medicines in breast cancer will be presented at ASCO (Free ASCO Whitepaper). Data includes results from the Phase III SANDPIPER study of taselisib (GDC-0332) and fulvestrant, compared to fulvestrant alone, in estrogen receptor (ER)-positive, PIK3CA-mutant, locally advanced or metastatic breast cancer, and updated OS data from the LOTUS trial of ipatasertib (GDC-0068, RG7440) and paclitaxel for previously untreated, locally advanced or metastatic, triple-negative breast cancer. The SANDPIPER data will be featured as part of ASCO (Free ASCO Whitepaper)’s official press programme on Saturday, 2 June.

Overview of key presentations featuring Roche medicines at ASCO (Free ASCO Whitepaper) 2018

About Roche in Oncology
Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anti-cancer chemotherapy drug, fluorouracil, to patients in 1962. Roche’s commitment to developing innovative medicines and diagnostics for cancers remains steadfast.

The Roche Group’s portfolio of innovative cancer medicines includes: Alecensa (alectinib); Avastin (bevacizumab); Cotellic (cobimetinib); Erivedge (vismodegib); Gazyva/Gazyvaro (obinutuzumab); Herceptin (trastuzumab); Kadcyla (trastuzumab emtansine); MabThera/Rituxan (rituximab); Perjeta (pertuzumab); Tarceva (erlotinib); Tecentriq (atezolizumab); Venclexta/Venclyxto (venetoclax); Xeloda (capecitabine); Zelboraf (vemurafenib). Furthermore, the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies.

For more information on Roche’s approach to cancer, visit Roche.com.

On May 8, 2018 Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical- stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, reported upcoming presentations during two conferences, both to take place May 16 – 19, 2018; the 21st annual American Society of Gene and Cell Therapy 2018 conference being held in Chicago, IL, and the International Investigative Dermatology conference being held in Orlando, FL (Press release, Abeona Therapeutics, MAY 8, 2018, View Source;p=RssLanding&cat=news&id=2347659 [SID1234526221]).

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American Society of Gene and Cell Therapy
View Source

Oral Presentations:

Phase 1/2 Clinical Trial for Recessive Dystrophic Epidermolysis Bullosa Using EB-101 (COL7A1 Gene-Corrected Autologous Keratinocytes)
Presenter: Jean Yuh Tang, M.D., Ph.D., Stanford University
Thursday, May 17, 2018
Time: 8:20 AM Central Time

Update on Phase 1/2 Gene Transfer Clinical Trial of Systemic Gene Transfer of scAAV9.U1a.hSGSH for MPSIIIA (Sanfilippo Syndrome)
Presenter: Kevin Flanigan, M.D., Nationwide Children’s Hospital
Friday, May 18, 2018
Time: 8:30 AM Central Time

A Phase 1/2 Clinical Trial of Systemic Gene Transfer of rAAV9.CMV.hNAGLU for MPS IIIB: Safety, Tolerability, and Preliminary Evidence of Biopotency
Presenter: Kevin Flanigan, M.D., Nationwide Children’s Hospital
Friday, May 18, 2018
Time: 4:30 PM Central Time

Symposium and Forum:

Assessing Neurodevelopment in Neurodegenerative Disease: The Use and Interpretation of Cognitive Scales
Presenter: Maria Escolar, M.D., Children’s Hospital of Pittsburgh of UPMC
Moderator: Barry Byrne, M.D., Ph.D., University of Florida
Thursday, May 17, 2018
Time: 7:00 AM Central Time

Tools and Technologies Forum
Co-Chair: S. Kaye Spratt, Ph.D., Abeona Therapeutics Inc.
Friday, May 18, 2018
Time: 5:45 PM – 7:45 PM Central Time

Poster Presentations:

Poster 547: Development of a Multi-Domain Responder Index for Clinical Trials with Multi-Domain Diseases
Presenter: Magdalena Tyrpien, Abeona Therapeutics Inc.
Thursday, May 17, 2018
Time: 5:15 PM Central Time

Poster 399: Identification of Novel AAV Capsids for Enhanced CNS Gene Transfer
Presenter: Daphne Chen, University of North Carolina, Chapel Hill
Thursday, May 17, 2018
Time: 5:15 PM Central Time

International Investigative Dermatology

View Source

Poster Presentation:

Poster 328: 50% Wound Healing Correlates with RDEB Patient Reported Outcomes in Pain, Itch, and Skin Durability
Friday, May 18, 2018
Time: 12:00 PM Eastern Time

On May 8, 2018 Kura Oncology, Inc., (Nasdaq: KURA) a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported first quarter 2018 financial results and provided a corporate update (Press release, Kura Oncology, MAY 8, 2018, View Source [SID1234526237]).

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"I am very pleased with the progress we made over the past quarter, highlighted by a successful end of Phase 2 meeting with the FDA," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We are working diligently to initiate AIM-HN, our registration-directed trial of tipifarnib in HRAS mutant HNSCC, as well as SEQ-HN, our concurrent screening and outcomes study. We believe that tipifarnib has the potential to become an important treatment option for patients with HRAS mutant HNSCC, and we are committed to executing the clinical and regulatory strategy that best positions it for success."

"We are also excited about the potential to expand the clinical utility of tipifarnib to other solid tumor and hematologic indications," continued Dr. Wilson. "We are evaluating tipifarnib in multiple biomarker-guided Phase 2 clinical trials, and our goal is to generate proof-of-concept data in one or more of these additional indications by year end. We believe we have the cash runway to advance tipifarnib and our emerging pipeline of drug candidates through a series of upcoming potential data catalysts, and we look forward to providing further updates on our progress in the months ahead."

Corporate Update

Registration-directed trial of tipifarnib in HRAS mutant HNSCC – Following a positive Phase 2 trial in HRAS mutant HNSCC and a successful end of Phase 2 meeting with the FDA, Kura is planning to conduct a global, registration-directed trial of its lead drug candidate tipifarnib in at least 59 recurrent or metastatic patients with HRAS mutant HNSCC. The primary endpoint of the trial will be objective response rate. Based on feedback from the FDA, Kura believes that the single-arm trial, if positive, could support an application for accelerated approval. Kura anticipates that the trial, called AIM-HN, will require fewer than 100 clinical sites worldwide and take approximately two years to enroll. Kura expects to initiate the AIM-HN trial in the second half of 2018.

Screening and outcomes study in HRAS mutant HNSCC – Concurrent with the AIM-HN trial, Kura is also planning to conduct a non-interventional, case-control study in HNSCC, called SEQ-HN. The study is expected to facilitate the identification of patients with HRAS mutations for potential enrollment into the AIM-HN trial. In addition, SEQ-HN is designed to characterize the natural history of patients with HRAS mutant HNSCC, which may support any future discussions with regulatory agencies concerning the appropriateness and nature of a potential approval.

Tipifarnib in HRAS mutant lung squamous cell carcinoma (LSCC) – Kura recently presented new preclinical data showing that tipifarnib is highly active in HRAS mutant LSCC tumor models. The data, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2018, illustrate the potential for tipifarnib in the treatment of HRAS mutant LSCC. Kura is collaborating with the Spanish Lung Cancer Group, a cooperative group consisting of more than 150 public and private oncology centers in Spain, on a proof-of-concept trial of tipifarnib in HRAS mutant LSCC. Kura anticipates this investigator-sponsored trial to initiate later this year.

Patent protection for tipifarnib in hematologic malignancies – Kura recently announced the issuance of U.S. patent 9,956,215, "Methods of Treating Cancer Patients with Farnesyltransferase Inhibitors." The newly issued patent includes multiple claims directed to the use of tipifarnib as a method of treating patients with CXCL12-expressing peripheral T-cell lymphoma (PTCL) and acute myeloid leukemia (AML) and has an expiration date of November 2037, excluding any possible patent term extension. This patent comes less than one year after the U.S. Patent and Trademark Office issued a similar patent for tipifarnib in HRAS mutant HNSCC, reinforcing the potential of Kura’s broader strategy to generate intellectual property related to its drug candidates and their use in treating genetically defined patient populations.

Potential biomarker for KO-947 in squamous cell carcinomas – At the AACR (Free AACR Whitepaper) Annual Meeting in April 2018, Kura presented new preclinical data for its ERK inhibitor, KO-947, including the identification of 11q13 amplification as a potential biomarker of activity in squamous cell carcinomas. Amplification of chromosomal region 11q13 is a common genetic alteration in squamous cell carcinomas, comprising approximately 20% of HNSCC and 50% of esophageal squamous cell carcinoma.

Upcoming Milestones

Initiation of AIM-HN, a registration-directed trial of tipifarnib in HRAS mutant HNSCC, and SEQ-HN, a non-interventional, case-control study in HRAS mutant HNSCC, in the second half of 2018

Additional data from RUN-HN, an ongoing Phase 2 trial of tipifarnib in HRAS mutant HNSCC, in the second half of 2018

Biomarker-enriched data from ongoing Phase 2 trials of tipifarnib in hematologic malignancies in the second half of 2018

Initiation of a proof-of-concept study of tipifarnib in HRAS mutant LSCC sponsored by the Spanish Lung Cancer Group in 2018

Data from a Phase 1 dose-escalation trial of KO-947 in solid tumors in the second half of 2018

Submission of an investigational new drug application for KO-539, a potent and selective inhibitor of the menin-MLL interaction, in late 2018 or early 2019

Financial Results

Research and development expenses for the first quarter of 2018 were $11.6 million, compared to $5.5 million for the first quarter of 2017.

General and administrative expenses for the first quarter of 2018 were $3.4 million, compared to $2.1 million for the first quarter of 2017.

Net loss for the first quarter of 2018 was $14.6 million, compared to $7.5 million for the first quarter of 2017.

Cash, cash equivalents and short-term investments totaled $138.2 million as of March 31, 2018, which included $57.7 million in net proceeds under an ATM facility in January 2018, compared with $93.1 million as of December 31, 2017.

Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund its current operations into the first half of 2020.

Conference Call and Webcast

Kura’s management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT today, May 8, 2018, to discuss the financial results for the first quarter of 2018 and provide a corporate update. The live call may be accessed by dialing (877)

516-3514 for domestic callers and (281) 973-6129 for international callers and using conference ID #7199738. A live webcast of the call will be available from the Investors and Media section of the company website at www.kuraoncology.com, and will be archived there for 30 days.

On May 8, 2018 OncoMed Pharmaceuticals, Inc. (NASDAQ: OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported first quarter 2018 financial results and provided a corporate update (Press release, OncoMed, MAY 8, 2018, View Source [SID1234526253]). As of March 31, 2018, cash, cash equivalents, and short-term investments totaled $88.4 million.

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"The Company is encouraged by ongoing clinical progress on its two most advanced immuno-oncology programs, anti-TIGIT and GITRL-Fc, and preclinical data on these programs were recently highlighted in multiple poster presentations at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. We also continue to dose patients in two Phase 1b studies of navicixizumab, our anti-DLL4/VEGF bispecific antibody. We look forward to delivering on numerous near-term catalysts, including the initiation of the Phase 1b portion of the anti-TIGIT study in combination with anti-PD1 in the second quarter of this year, the publication of the navicixizumab Phase 1a manuscript and the presentation of the navicixizumab Phase 1b ovarian cancer data in the second half of 2018, and the planned presentation of the anti-TIGIT Phase 1a data in the fourth quarter of 2018," stated John Lewicki, Ph.D., President and CEO of OncoMed.

Pipeline Highlights

Anti-TIGIT (OMP-313M32)

OncoMed plans to initiate dosing of the Phase 1b portion of its Phase 1a/b anti-TIGIT (OMP-313M32) trial, in combination with anti-PD1, in the second quarter of 2018. The Phase 1b portion of the open-label clinical trial is designed to assess the safety, tolerability, preliminary efficacy, and pharmacodynamic biomarkers of escalating doses of OMP-313M32 in combination with anti-PD1 for the treatment of patients with solid tumors who have progressed after prior treatment with anti-PD1 or anti-PD-L1.

OncoMed continues enrollment in the Phase 1a single-agent study of anti-TIGIT in patients with advanced or metastatic solid tumors. The Phase 1a study is designed to assess safety and tolerability of escalating doses of anti-TIGIT. Biomarkers will be assessed in this study which includes a single-agent dose expansion cohort.

The company currently expects to present data from the Phase 1a portion of the Phase 1a/b study in the fourth quarter of 2018.

Navicixizumab (anti-DLL4/VEGF bispecific; OMP-305B83)

Enrollment continues in two Phase 1b multi-center, open-label, dose escalation and expansion studies of OncoMed’s anti-DLL4/VEGF bispecific antibody in combination with standard-of-care chemotherapies: one in patients with platinum-resistant ovarian cancer who have failed more than two prior therapies or prior bevacizumab and a second in patients with 2nd line metastatic colorectal cancer.

To date, OncoMed has enrolled approximately 100 patients across the Phase 1a and Phase 1b trials of navicixizumab.

The Phase 1a data are expected to be published in the second half of 2018, and interim data from the ongoing Phase 1b ovarian cancer study are also expected to be reported in the second half of 2018.

GITRL-Fc (OMP-336B11)

Robust enrollment continues in the Phase 1a single-agent study of its wholly-owned GITRL-Fc in patients with advanced or metastatic solid tumors. GITRL-Fc is a fusion protein with an Fc-linked fully human trimer ligand and is designed to activate the co-stimulatory receptor GITR (glucocorticoid-induced tumor necrosis factor receptor-related protein) to enhance T-cell modulated immune responses. The Phase 1a study is designed to assess safety and tolerability of escalating doses.

The Phase 1a data are expected to be presented in 2019.

New product discovery

OncoMed continues to make strong progress in its pursuit of novel immune-oncology agents, including emerging opportunities from the TNF superfamily of ligands, using the company’s proprietary linkerless fully human trimer technology.

First Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments totaled $88.4 million as of March 31, 2018, compared to $103.1 million as of December 31, 2017.

Revenues were $7.8 million for the first quarter of 2018, an increase of $1.6 million, compared to $6.2 million for the same period in 2017. The change in revenue was due to the effect of the adoption of the new revenue recognition standard in the first quarter of 2018. For further discussion regarding our adoption of the new revenue recognition standard and its effects, see page 12 of our Quarterly Report on Form 10-Q for the first quarter ended March 31, 2018, filed with the Securities and Exchange Commission on May 8, 2018.

Research and development (R&D) expenses were $8.4 million for the first quarter of 2018, a decrease of $15.6 million, compared to $24.0 million for the same period in 2017. The decrease in R&D expenses was due to decreases in clinical development costs and reduced headcount following the restructuring actions in April 2017.

General and administrative (G&A) expenses were $5.4 million for the first quarter of 2018, an increase of $0.4 million, compared to $5.0 million for the same period in 2017. The increase in G&A expenses was primarily due to an increase in personnel cost, including retention bonus and severance expenses in the first quarter of 2018, offset by a decrease in headcount as a result of restructuring actions in April 2017.

Net loss for the first quarter of 2018 was $5.6 million ($0.15 per share), compared to $22.6 million ($0.61 per share) for the same period of 2017. The change in year-over-year net loss was primarily due to lower operating expenses in the first quarter of 2018.

2018 Financial Guidance

OncoMed’s current cash is estimated to be sufficient to fund operations through at least the third quarter of 2019, without taking into account future potential milestone or opt-in payments from its partners. OncoMed estimates 2018 operating cash burn to be approximately $55 million, before considering potential milestone or opt-in payments.