On January 7, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported anticipated 2019 milestones for IPI-549, a first-in-class, oral, immuno-oncology product candidate targeting tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition and provided financial guidance for 2019 (Press release, Infinity Pharmaceuticals, JAN 7, 2019, View Source [SID1234532501]).

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"In the year ahead, we are excited to be moving into earlier lines of therapy, new indications, and novel, potentially transformative immuno-oncology combinations to execute on our strategy to expand the depth and breadth of the development of IPI-549," said Adelene Perkins, Chief Executive Officer of Infinity Pharmaceuticals. "Importantly, we have a cash runway into the second half of 2020, which enables us to advance IPI-549 development in several innovative studies in 2019. We also have the support of tremendous collaborators BMS and Arcus for two of these potentially transformative studies."

"The IPI-549 safety and clinical activity from the MARIO-1 Phase 1b study continues to inform our strategy to expand the depth and breadth of IPI-549 development for cancer patients," said Dr. Sam Agresta, Chief Medical Officer of Infinity. "MARIO-275 is our first global, randomized study of IPI-549 in combination with Opdivo compared to Opdivo monotherapy. This study, in collaboration with BMS, is designed to address an unmet medical need for patients with advanced urothelial cancer and is an important step in advancing IPI-549 development beyond the checkpoint inhibitor refractory setting. In addition, the safety, clinical activity and mechanism of action of IPI-549 allows us to expand the breadth of the program by moving into novel combinations, including in previously treated, advanced triple negative breast cancer patients, with a novel triple therapy study in collaboration with Arcus. And I am particularly excited to initiate our first IPI-549 study in the front-line setting in 2019."

Infinity plans to initiate MARIO-275, a combination study of IPI-549 with Opdivo in I/O naïve urothelial cancer (UC) patients, in the first half of 2019. Opdivo was approved for use by the FDA as a single agent in advanced urothelial cancer based on durable response associated with treatment in CheckMate-275, a Phase 2 single arm clinical trial of Opdivo in subjects with metastatic or unresectable urothelial cancer who have progressed or recurred following treatment with a platinum agent1. Retrospective analyses of this study showed that patients with higher levels of myeloid derived suppressor cells, or MDSCs, had poor outcomes2. IPI-549 has been shown to reduce MDSCs as both a monotherapy and in combination with Opdivo in MARIO-13-6. MARIO-275 is intended to evaluate the benefit of adding IPI-549 to Opdivo in cisplatin-refractory, I/O-naive urothelial cancer patients. Clinical benefit will be assessed in the overall population as well as in subsets of patients with different baseline levels of MDSCs.

Infinity will also be advancing novel triple combination therapies with Arcus, initially evaluating IPI-549 in combination with AB928, Arcus’s dual adenosine receptor antagonist, and chemotherapy in patients with previously treated, advanced triple negative breast cancer, or TNBC. As both macrophages and high adenosine levels are believed to play critical roles in creating a highly immune-suppressive tumor microenvironment in cancer after chemotherapy, the novel immuno-oncology combination being evaluated in this setting represent a potentially promising approach to treating TNBC.

Infinity’s chair and chief executive officer, Adelene Perkins, will discuss the company’s continued execution on its corporate strategy and 2019 priorities as part of a podium presentation at the 37th Annual J.P. Morgan Healthcare Conference on Thursday, January 10, at 9:30 a.m. PST (12:30 p.m. EST). The presentation will be webcast live on Infinity’s website, www.infi.com, and an archived version of the webcast will be available on Infinity’s website for 30 days.

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

1H2019

Advance into Immuno-Oncology (I/O) Naïve Indications in Combination with Opdivo: Initiate MARIO-275 in I/O naïve UC patients with BMS
Advance into Novel Triple Combinations Beyond CPIs: Initiate Triple Therapy Combination (IPI-549+AB928+Chemo) in previously treated advanced TNBC with Arcus
2H2019

Initiate the first IPI-549 combination study in front-line advanced cancer patients
Complete enrollment of MARIO-1 seven combination expansion cohorts including:
Augmented melanoma expansion cohort (n=40)
TNBC expansion cohort (n=29)
2019 Financial Guidance

Infinity ended 2018 with approximately $58.6 million in cash and investments (unaudited) and plans to report its fourth quarter and full-year 2018 financial results in March. The company is providing the following financial guidance today:

Net loss: $30 million to $40 million
Year-end cash: $20 million to $30 million
Cash runway: Into 2H 2020
Infinity’s 2019 financial guidance is based on its current operating plans, excludes additional financing or business development activities, and includes a $2 million milestone payment from PellePharm, a private company, upon initiation of a Phase 3 study for the hedgehog inhibitor program, which Infinity licensed to PellePharm in 2013.

IPI-549 is an investigational compound, and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On January 7, 2019 Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that the Company will be presenting at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, California (Press release, Dr Reddy’s, JAN 7, 2019, View Source [SID1234532500]).

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The Company’s Senior Management will present on Tuesday, January 8th, 2019 at 1:30 PM PST [3:00 AM IST on January 9 th, 2019].

The live webcast for the presentation can be accessed on company’s website www.drreddys.com. The transcript and the presentation material of the event will be available on the Company’s website as well.

On January 7, 2019 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported preliminary unaudited fourth quarter and full year 2018 financial results and provided 2019 financial guidance (Press release, AMAG Pharmaceuticals, JAN 7, 2019, View Source [SID1234532499]).

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The company will provide a portfolio update at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 9, 2019 at 7:30 a.m. PT (10:30 a.m. ET). A live audio webcast of the presentation and following breakout session will be accessible through the Investors section of AMAG’s website at www.amagpharma.com.

"In 2018, we achieved several key milestones including receiving two approvals from the U.S. Food and Drug Administration (FDA), launching both the Makena subcutaneous auto-injector and Feraheme broad label, and receiving FDA acceptance of our new drug application for VyleesiTM (bremelanotide). In addition, we bolstered our pipeline by adding two promising late-stage development assets, AMAG-423 and ciraparantag, targeting orphan patient populations," said William Heiden, AMAG’s president and chief executive officer.

"As we enter 2019, AMAG is in a unique position with a number of growing commercial products that together generate significant cash flows, allowing us to invest in the development and launch of our new pharmaceutical products. We have built an innovative and diversified portfolio that I believe positions us well for long-term growth and will deliver significant shareholder value," added Mr. Heiden.

Preliminary Fourth Quarter and Full Year 2018 Financial Results (unaudited)
Fourth Quarter 2018
AMAG expects total revenues from continuing operations for the fourth quarter of 2018 to be between $85 million and $90 million. This includes Makena (hydroxyprogesterone caproate injection) net product sales of between $46 million and $48 million, Feraheme and MuGard net product sales of between $34 million and $36 million, and Intrarosa net product sales of between $5 million and $6 million. The Makena subcutaneous auto-injector maintained market share in the fourth quarter, as compared to the third quarter, despite the entry of generic competition to the intramuscular product. In addition, Makena ex-factory sales were impacted by a reduction in channel inventory levels in the fourth quarter, as compared to third quarter, due to temporary supply constraints, which are now resolved. Fourth quarter Feraheme revenues grew approximately 34% over prior year, driven by continuing success of the product’s expanded label. Intrarosa revenues were driven by strong prescription volume and market share growth in the quarter.

For the fourth quarter of 2018, AMAG expects an operating loss of between $17 million and $27 million. Adjusted EBITDA (earnings before interest, taxes, depreciation and amortization) for the fourth quarter of 2018 is expected to be within the company’s forecasted range of between a loss of $5 million and positive adjusted EBITDA of $5 million.

Full Year 2018
AMAG expects full year 2018 revenues and adjusted EBITDA to be within the company’s most recently issued financial guidance range. Total revenues from continuing operations are expected to be between $471 million and $476 million. This includes Makena net product sales of between $321 million and $323 million, Feraheme and MuGard net product sales of between $134 million and $136 million, and Intrarosa net product sales of between $15 million and $16 million. As a result of the sale of Cord Blood Registry (CBR), which closed on August 6, 2018, CBR’s results have been excluded from the financial results.

For the full year of 2018, AMAG expects an operating loss of between $45 million and $55 million and adjusted EBITDA of between $115 million and $125 million.2

The company ended 2018 with approximately $394 million in cash and investments, $21.4 million of short-term debt and $320 million of 2022 convertible notes (principal amount outstanding).

The company expects to report final financial results for the fourth quarter and audited results for the full year of 2018 in February.

2019 Overview
The company has a number of goals and key milestones upcoming in 2019:

Expand use of Makena subcutaneous auto-injector

Drive Feraheme growth

Continue successful Intrarosa direct-to-consumer campaign

Submit Vyleesi frequent-dosing study results prior to updated PDUFA date of June 23, 2019; prepare for commercial launch in 2H-2019

Target full enrollment in AMAG-423 Phase 2b/3a study by year end

Initiate ciraparantag Phase 3a clinical study

Pursue in/out-licensing opportunities

Meet/exceed financial guidance

The company is providing the following financial guidance for 2019:
$ in millions
2019 Financial Guidance
Total revenue
$365 – $415
Operating loss
($131) – ($101)
Adjusted EBITDA
($65) – ($35)

"During 2018, we increased our financial guidance three times and reported that we achieved our financial objectives for the full year of 2018," said Ted Myles, AMAG’s chief financial officer. "We also completed the transformation of our balance sheet, and with nearly $400 million of cash on hand and approximately $20 million in near-term debt, we are well positioned to advance our portfolio of novel products."

"2019 will be a year of investment and we are in the fortunate position that our cash flow generating products and our balance sheet can support the development of our future products; each of which has significant revenue and growth prospects because they provide innovative therapeutic solutions to patients with unmet medical needs," added Mr. Myles.

Webcast Information
A live audio webcast of the company’s presentation and the following breakout session, along with the accompanying slide presentation at the 37th Annual J.P. Morgan Healthcare Conference, will be accessible through the Investors section of the company’s website at www.amagpharma.com on January 9, 2019 at 7:30 a.m. PT (10:30 a.m. ET). Following the conference, the webcast will be archived on the company’s website until February 9, 2019.

Use of Non-GAAP Financial Measures
AMAG has presented certain non-GAAP financial measures, including non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization). These non-GAAP financial measures exclude certain amounts, expenses or income, from the corresponding financial measures determined in accordance with accounting principles generally accepted in the U.S. (GAAP). Management believes this non-GAAP information is useful for investors, taken in conjunction with AMAG’s GAAP financial statements, because it provides greater transparency regarding AMAG’s operating performance. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of AMAG’s operating results as reported under GAAP, not as a substitute for GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures are included in the tables accompanying this press release

On January 7, 2019 Aduro Biotech, Inc presented the corporate presentation (Presentation, Aduro Biotech, JAN 7, 2019, View Source [SID1234532498]).

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On January 6, 2019 The University of Texas MD Anderson Cancer Center and 4D pharma reported a strategic collaboration to evaluate 4D’s live biotherapeutic oncology pipeline across a range of cancer settings (Press release, MD Anderson, JAN 6, 2019, View Source [SID1234553989]).

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The alliance brings together MD Anderson’s translational medicine and clinical research capabilities with 4D’s expertise in the discovery and development of live biotherapeutics. The collaboration will initially assess the 4D’s lead oncology candidate, MRx0518, as a potential treatment for solid tumors.

The first clinical trial, an open label Phase I study of MRx0518 in combination with Keytruda and conducted in collaboration with Merck & Co., Inc., Kenilworth, N.J., has been initiated and is due to open shortly. The study will enroll up to 132 patients with metastatic cancer across multiple histologies who progressed on prior anti-PD-1 therapy.

Subsequent studies are also being planned under the collaboration, including using MRx0518 in combination with stereotactic body radiotherapy (SBRT) for the treatment of pancreatic cancer.

"This alliance, with one of the leading oncology research centers in the world, will provide a strong and long-term foundation for the development of 4D’s live biotherapeutics in cancer," said Duncan Peyton, 4D’s chief executive officer. "The current study, which is one of the first live biotherapeutic programs to reach the clinic in the immuno-oncology space, represents an important step forward in the development of MRx0518 and 4D’s broader oncology franchise. We look forward to continuing to work with our partners at MD Anderson to progress this study and help bring this therapy to patients."