On May 2, 2018 MannKind Corporation(Nasdaq:MNKD) reported that it will release its 2018 first quarter financial results on Wednesday, May 9, 2018 and its management will host a conference call to discuss the financial results and other Company developments at 5:00 PM (Eastern Time) on May 9, 2018 (Press release, Mannkind, MAY 2, 2018, View Source [SID1234525992]).

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Presenting from the Company will be its Chief Executive Officer, Michael Castagna, Chief Financial Officer, Steven Binder, Chief Commercial Officer, Pat McCauley and Chief Medical Officer, David Kendall.

To view and listen to the earnings call webcast live via the Internet, visit the Company’s website at www.mannkindcorp.com and click on the "Q1 2018 MannKind Earnings Conference Call" link in the Webcasts section of News & Events. To participate in the live call by telephone, please dial (800) 289-0438 toll-free or (323) 794-2423 toll/international and use the conference passcode: 3321662.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 toll-free or (412) 317-6671 toll/international and use the replay passcode: 3321662. A replay will also be available on MannKind’s website for 14 days.

On May 2, 2018 Acorda Therapeutics, Inc. (Nasdaq: ACOR)reported update for the quarter ended March 31, 2018 (Press release, Acorda Therapeutics, MAY 2, 2018, View Source [SID1234525937]).

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"With FDA’s acceptance of Acorda’s NDA for INBRIJA and a PDUFA date of October 5, 2018, we are focused on preparations for the potential U.S. approval and launch," said Ron Cohen, M.D., Acorda’s President and CEO. "We are also looking forward to the opportunity to argue our case for our AMPYRA patents at the U.S. Court of Appeals on June 7."

First Quarter 2018 Financial Results

AMPYRA (dalfampridine) Extended Release Tablets, 10 mg – For the quarter ended March 31, 2018, the Company reported AMPYRA net revenue of $102.8 million compared to $112.0 million for the same quarter in 2017. The quarter over quarter reduction in net revenue was primarily related to a modest expansion in customer inventories in the fourth quarter 2017 which normalized by the end of the first quarter 2018.

Research and development (R&D) expenses for the quarter ended March 31, 2018 were $30.6 million, including $1.7 million of share-based compensation compared to $46.5 million, including $2.5 million of share-based compensation for the same quarter in 2017. Quarter-over-quarter reductions in R&D expenses are primarily the result of our corporate restructuring which occurred in 2017.

Sales, general and administrative (SG&A) expenses for the quarter ended March 31, 2018 were $47.6 million, including $4.2 million of share-based compensation compared to $52.0 million, including $5.3 million of share-based compensation for the same quarter in 2017. Quarter-over-quarter reductions in SG&A expenses are primarily the result of our corporate restructuring which occurred in 2017.

Provision for income taxes for the quarter ended March 31, 2018 was $3.5 million, including $0.5 million of cash taxes, compared to a benefit from income taxes of $0.9 million, including $1.9 million of cash taxes for the same quarter in 2017.

The Company reported a GAAP net loss of $8.2 million for the quarter ended March 31, 2018, or $0.18 per diluted share. GAAP net loss in the same quarter of 2017 was $18.9 million, or $0.41 per diluted share.

Non-GAAP net income for the quarter ended March 31, 2018 was $6.8 million, or $0.14 per diluted share. Non-GAAP net loss in the same quarter of 2017 was $3.6 million, or $0.08 per diluted share. This quarterly non-GAAP net income (loss) measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, and acquisition-related expenses. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At March 31, 2018, the Company had cash, cash equivalents and short-term investments of $333.0 million.

Guidance for 2018

The Company reiterates AMPYRA 2018 net revenue guidance of $330-$350 million. The Company expects to maintain exclusivity of AMPYRA at least through July 30, 2018; this guidance is subject to change based on the appellate court’s decision.
R&D expenses for the full year 2018 are expected to be $100-$110 million and include manufacturing expenses associated with INBRIJA. This guidance is a non-GAAP projection that excludes share-based compensation, as more fully described below under "Non-GAAP Financial Measures."
SG&A expenses for the full year 2018 are expected to be $170-$180 million. This guidance is a non-GAAP projection that excludes share-based compensation, as more fully described below under "Non-GAAP Financial Measures."
The Company expects to end 2018 with a projected year-end cash balance in excess of $300 million.
First Quarter 2018 Pipeline and Corporate Updates

INBRIJA (levodopa inhalation powder)
In February, the FDA notified the Company that it had accepted for filing the New Drug Application (NDA) for INBRIJA. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of October 5, 2018 for issuing its decision on the NDA.
In March, the Company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for INBRIJA. Acorda is seeking approval to market INBRIJA in the European Union.
In April, the Company presented new INBRIJA data from four accepted abstracts during two oral platform presentations at the American Academy of Neurology Annual Meeting in Los Angeles. A safety assessment in early morning OFF symptoms in patients with Parkinson’s disease (Study 009) was presented by Dr. Stuart H. Isaacson and Dr. Robert H. Hauser; long-term pulmonary safety and efficacy of inhaled levodopa in Parkinson’s disease (Study 005) was presented by Charles Oh, MD, VP Clinical Development at Acorda.
AMPYRA Patent Appeal
Oral argument before the U.S. Court of Appeals for the Federal Circuit has been scheduled for June 7, 2018.
rHIgM22 Update
Data from the rHIgM22 Phase 1 study in 27 people with acute relapsing multiple sclerosis showed that a single dose of rHIgM22 was not associated with any safety signals. The study’s primary endpoint was safety and tolerability of a single dose following a relapse.
The study was not powered to show efficacy and exploratory efficacy measures showed no difference between the treatment groups.
Webcast and Conference Call

The Company will host a conference call today at 8:30 a.m. ET. To participate in the conference call, please dial (833) 236-2756 (domestic) or (647) 689-4181 (international) and reference the access code 2477088. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 11:30 a.m. ET on May 2, 2018 until 11:59 p.m. ET on June 2, 2018. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 2477088.

Non-GAAP Financial Measures

This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also certain historical and forward-looking non-GAAP financial measures. In particular, Acorda has provided non-GAAP net income, adjusted to exclude the items below, and has provided 2018 guidance for R&D and SG&A expenses on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes the presentation of non-GAAP net income, when viewed in conjunction with our GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) non-cash interest charges related to the accounting for our outstanding convertible debt which are in excess of the actual interest expense owing on such convertible debt as well as non-cash interest related to the Fampyra monetization, non-cash interest charges related to our asset based loan which was terminated in 2017 and acquired Biotie debt, (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, and (iv) acquisition related expenses and related foreign currency losses and gains that pertain to a non-recurring event. The Company believes its non-GAAP net income measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding projected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

In addition to non-GAAP net income, we have provided 2018 guidance for R&D and SG&A expenses on a non-GAAP basis. Due to the forward looking nature of this information, the amount of compensation charges and benefits needed to reconcile these measures to the most directly comparable GAAP financial measures is dependent on future changes in the market price of our common stock and is not available at this time. The Company believes that these non-GAAP measures, when viewed in conjunction with our GAAP results, provide investors with a more meaningful understanding of our ongoing and projected R&D and SG&A expenses. Also, management uses these non-GAAP financial measures to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

On May 2, 2018 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) requesting approval to initiate a Phase 1 clinical trial for UCART22, Cellectis’ second wholly controlled TALEN gene-edited product candidate, for the treatment of B-cell acute lymphoblastic leukemia (B-ALL) in adult patients (Press release, Cellectis, MAY 2, 2018, View Source;utm_medium=feed&utm_campaign=Feed%3A+cellectis+%28Cellectis+RSS+Feed%29#When:20:30:00Z [SID1234525958]).

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Pending regulatory clearance, Cellectis plans to initiate a Phase I clinical trial in the third quarter of 2018. The clinical research will be led by Dr. Nitin Jain, Assistant Professor, and Prof. Hagop Kantarjian, Chairman in the Department of Leukemia and University Chair in Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston.

"This IND application for UCART22 is an important regulatory milestone for the Company," said Stephan Reynier, Chief Regulatory and Compliance Officer, Cellectis. "The first ever FDA approval for a CAR T-cell therapy, directed against CD19, for pediatric and young patients with R/R B-ALL occurred in 2017. However, further CART approaches are needed, as some limitations of the CD19-CART treatment appear to be due to the expansion of CD19-negative leukemia clones.[1] The UCART22 product candidate will be evaluated in relapsed or refractory CD22 B-ALL, including relapses after CD19 CAR-T administration."

Acute lymphoblastic leukemia (ALL) is a rapidly progressing form of leukemia that is characterized by the presence of a large number of immature white blood cells in the blood and bone marrow. In 2016, an estimated 6,590 new cases were diagnosed in the U.S., with over 1,400 deaths due to ALL.[2] Approximately 85 percent of ALL cases involve precursor B-cells (B-ALL).

UCART22 is an allogeneic, off-the-shelf gene-edited T-cell product candidate designed for the treatment of B-ALL. Like CD19, CD22 is a cell surface antigen expressed from the pre B-cell stage of development through mature B-cells and CD22 expression occurs in more than 90 percent of patients with B-ALL.[3]

"Given the high unmet medical need for patients who suffer from B-ALL, filing the IND is the first vital step to potentially creating a treatment to be manufactured on an industrial scale, allowing these patients to get the help that they need much faster," added Prof. Stéphane Depil, Senior Vice President Research & Development and Chief Medical Officer. "We are dedicated to making this a reality as soon as possible and look forward to hitting the ground running with the clinical trial once we obtain regulatory clearance."

The manufacturing process of Cellectis’ allogeneic CAR T-cell product line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, non-alloreactive engineered CAR T-cells. UCARTs are meant to be readily available CAR T-cells for a large patient population. Their production is industrialized with defined pharmaceutical release criteria.

On May 2, 2018 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported that there will be a Symposium on the Company’s lead drug Fexapotide held at the Annual Meeting of the American Urological Association on May 20 in San Francisco (Press release, Nymox, MAY 2, 2018, View Source [SID1234525975]). The Symposium is entitled:

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"Phase 3 Clinical Studies and Biology of Fexapotide Triflutate Office Injectable for BPH"

and will feature a presentation reviewing therapeutic highlights from the Company’s extensive Phase III trials involving more than 970 patients in the United States. The presentation is chaired by Dr. Ronald Tutrone of Chesapeake Urology Research Associates, Baltimore MD and a panel discussion with panel members including Dr. Mohamed Bidair, San Diego CA; Dr. Ivan Grunberger, New York NY; Dr. Alan Hay, Salem OR; Dr. Susan Kalota, Tucson AZ and Dr. Jeffrey Snyder, Denver CO.

The Annual Meeting of the AUA is the largest urology meeting held annually in the US and brings together over a 4 day period urologists and health care providers, industry and interested parties from across the world with an expected attendance of over 16,000 visitors.

Nymox’s fexapotide has been shown to produce long-term improvements in lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH), a problem that afflicts an estimated 100 million or more men in the world. Fexapotide does not cause the annoying side effects and risks found with available treatments for BPH and has also been shown to lower the occurrence of surgery for BPH. Fexapotide is also in development for low grade prostate cancer.

For more information please contact [email protected] or 800-936-9669.

Forward Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding Nymox, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the need for new options to treat BPH and prostate cancer, the potential of Fexapotide to treat BPH and prostate cancer and the estimated timing of further developments for Fexapotide. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of Nymox’s regulatory filings, Nymox’s substantial dependence on Fexapotide, Nymox’s commercialization plans and efforts and other matters that could affect the availability or commercial potential of Fexapotide. Nymox undertakes no obligation to update or revise any forward looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Nymox in general, see Nymox’s current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F for the year ended December 31, 2017, and its Quarterly Reports

On May 2, 2018 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the 2018 Bank of America Merrill Lynch Health Care Conference on Wednesday, May 16, 2018 (Press release, Incyte, MAY 2, 2018, View Source [SID1234525938]). Richard A. Gonzalez, chairman and chief executive officer, will present at 6:20 p.m. Central time.

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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.