Acorda Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On May 9, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant infections, reported that its corporate presentation will be webcast live at the UBS Global Healthcare Conference on Monday, May 21 at 1:00 p.m. Eastern Time at the Grant Hyatt New York in New York City (Press release, Tetraphase, MAY 9, 2018, View Source [SID1234526321]). Live audio webcasts of the presentation will be available on the company’s website at View Source Archived presentations will be available for 30 days.

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On May 9, 2018 Immunomedics, Inc. (NASDAQ:IMMU) ("Immunomedics" or the "Company"), a science-based and innovation-focused biopharmaceutical company committed to the development and worldwide commercialization of its unique and proprietary antibody-drug conjugate (ADC) platform, reported financial results for the third quarter ended March 31, 2018 (Press release, Immunomedics, MAY 9, 2018, View Source [SID1234526371]). The Company also highlighted recent key progress and planned activities for its sacituzumab govitecan program. Please refer to the Company’s Quarterly Report on Form 10-Q filed today with the SEC for more details on the Company’s financial results.

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"We have made tremendous progress in achieving our regulatory, clinical and organizational objectives in the prior quarter. Through the outstanding work of our colleagues, we remain on track to file our first BLA with the FDA later this month for the approval of sacituzumab govitecan for the treatment of metastatic triple-negative breast cancer (mTNBC). The FDA has previously granted us Breakthrough Therapy Designation for the treatment of patients with mTNBC who received at least two prior therapies for metastatic disease," stated Michael Pehl, President and Chief Executive Officer of Immunomedics. "In addition, Rob Iannone joined us as the Head of R&D and Chief Medical Officer, and under his leadership we will continue to unlock the full potential of sacituzumab govitecan, as well as new value creation opportunities with our unique ADC platform."

Highlights of Recent Progress

In March 2018, the Phase 3 ASCENT study dosed the first patient in Europe, reflecting the encouraging progress of the confirmatory trial with sacituzumab govitecan in patients with mTNBC.

In March 2018, the Company’s abstract on the efficacy of sacituzumab govitecan for treatment-refractive, HR+, HER2- mBC was selected for oral presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

In April 2018, Immunomedics further expanded its executive leadership team with the appointment of Robert Iannone, M.D., M.S.C.E., as Head of Research & Development and Chief Medical Officer. Dr. Iannone brings more than 13 years of experience in clinical drug development, including the approval of several targeted and immuno-oncology medicines at AstraZeneca/MedImmune and Merck & Co.

In April 2018, the FDA agreed to the Company’s proposed amendments to the confirmatory ASCENT trial protocol that is under a Special Protocol Assessment (SPA). The amendments incorporated recommendations from EU National Health authorities and advice from key breast cancer experts. As a result, the sample size will be increased to 488 patients, and will ensure robust power to evaluate the key objectives in the primary population of interest. Based on strong early enrollment trends, these changes are not expected to meaningfully impact overall study timelines. Immunomedics believes that the FDA’s agreement to this SPA amendment may further increase the probability of success of the study, while leaving key study objectives and endpoints intact.
Key Upcoming Events/Anticipated Milestones

BLA submission for accelerated approval of sacituzumab govitecan in third-line mTNBC (May 2018).

Oral presentation of results with sacituzumab govitecan in patients with HR+/HER2- mBC at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting (morning of Sunday, June 3, 2018).

Investor Event at ASCO (Free ASCO Whitepaper) (evening of Sunday, June 3, 2018).
Third Quarter and Nine Months Fiscal 2018 Results

Total revenues were $0.5 million for the third fiscal quarter ended March 31, 2018 and $1.8 million for the nine months ended March 31, 2018, compared to $1.3 million in the third fiscal quarter ended March 31, 2017 and $2.4 million for the nine months ended March 31, 2017. The decreases were due primarily to lower sales volume of LeukoScan in Europe. The Company discontinued the sale of LeukoScan during the third quarter of fiscal 2018 to focus on its ADC business.

Total costs and expenses were $38.1 million for the quarter and $90.4 million for the nine months ended March 31, 2018, compared to $23.4 million in the third quarter and $54.9 million for the nine months for the prior fiscal year. The higher costs and expenses in the third quarter and nine months of fiscal 2018 were due primarily to increases in research and development expenses as well as in sales and marketing expenses. The increases in third quarter costs and expenses of fiscal 2018 were offset partially by a $3.6 million decrease in general and administrative expenses in the third quarter due primarily to higher legal and advisory fees incurred in fiscal 2017 during the Company’s proxy contest.

The increases in research and development expenses were due primarily to increases in clinical trial costs as well as increases in labor related costs in connection with preparations for the regulatory submission and launch of sacituzumab govitecan in the United States for patients with mTNBC. The increases in sales and marketing expenses were due primarily to commercial launch preparation activities.

The Company recognized $9.8 million in non-cash income for the quarter and $49.8 million in non-cash expense for the nine months ended March 31, 2018, compared to $28.3 million in non-cash expense for the third quarter and $35.6 million for the nine months for the prior fiscal year. The changes in non-cash cost were due to the change in the fair value of warrant liabilities.

Net loss attributable to stockholders was $35.5 million, or $0.21 per share, for the quarter ended March 31, 2018, compared to net loss attributable to stockholders of $59.3 million, or $0.55 per share, for the same quarter in fiscal 2017. Net loss attributable to stockholders was $156.8 million, or $1.08 per share, for the nine months ended March 31, 2018, compared to net loss attributable to stockholders of $99.9 million, or $0.97 per share, for the same period in fiscal 2017.

As of March 31, 2018, the Company had $358.8 million in cash, cash equivalents, and marketable securities which it believes is sufficient to support its next phase of growth and continue operations into 2020.

Conference Call
The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss financial results for the third quarter of fiscal year 2018, and review key clinical developments and planned activities. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 9679918. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.

On May 9, 2018 Protagonist Therapeutics, Inc. (Nasdaq: PTGX) reported its financial results for the first quarter ended March 31, 2018 (Press release, Protagonist, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348218 [SID1234526387]).

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"Protagonist is continuing to build a broad and diverse pipeline of potentially transformative drug candidates discovered through its innovative peptide technology platform," said Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "PTG-200, the IL-23 receptor antagonist being developed in collaboration with Janssen Biotech, Inc., is currently in a Phase 1 study, and we expect a U.S. IND filing by the end of 2018 to support a Phase 2 global study in Crohn’s disease. With our hepcidin mimetic PTG-300, we plan to commence a Phase 2 study in beta-thalassemia patients in the fourth quarter of 2018."

"In addition to developing PTG-200 and PTG-300, we are conducting a comprehensive review of the PTG-100 dataset from the Phase 2b PROPEL study and expect to report our findings in the third quarter of 2018. As previously announced, we discontinued the trial based on a planned interim analysis by an independent Data Monitoring Committee and noted that it also showed an unexpectedly high placebo response rate," continued Dr. Patel.

Product Development Update:

PTG-100

A planned interim analysis was conducted during the first quarter for the Phase 2b PROPEL study of PTG-100, the company’s investigational oral GI-restricted alpha-4-beta-7 integrin antagonist peptide, in patients with moderate to severe ulcerative colitis. The Data Monitoring Committee reported that the interim analysis met prespecified futility criteria on the primary endpoint of clinical remission, and as a result the study was discontinued. It was also noted that the study experienced an unusually high placebo response rate.
Protagonist is now conducting an extensive review of the complete dataset from all patients enrolled in the Phase 2b trial. The Company will determine next steps for PTG-100 and for the general therapeutic approach of oral, GI-restricted alpha-4-beta-7-integrin antagonists after completing this review which is expected to be in the third quarter of 2018.
PTG-200

Dosing has been completed for all cohorts in the Phase 1 study of PTG-200, a first-in-class oral, GI restricted, IL-23 receptor antagonist peptide, which is partnered with Janssen Biotech, Inc. (Janssen). The Phase 1 study in normal healthy volunteers was initiated in Australia in November 2017 and involves single-ascending doses and multiple ascending doses of PTG-200.
In the second half of 2018 we expect a U.S. IND filing and other regulatory filings for a global Phase 2 study of PTG-200 in Crohn’s disease to be conducted in collaboration with Janssen.
PTG-300

PTG-300, an injectable hepcidin mimetic, is in development for the potential treatment of anemia and iron overload related to rare blood disorders. We have completed discussions with U.S. and global regulatory agencies, and the Company plans to file a U.S. IND and other regulatory filings in the third quarter of 2018 with the intent to commence a global Phase 2 trial in Q4 2018 in patients with beta-thalassemia. Furthermore, treatment of anemia and transfusion-dependence in myelodysplastic syndromes and exaggerated erythropoiesis in polycythemia vera represent additional opportunities for further development of PTG-300.
The U.S. Food and Drug Administration granted Orphan Drug Designation to PTG-300 for the treatment of beta-thalassemia in March of 2018.
Preclinical programs

The Company’s oral peptide agonist targeting the mu/delta opioid receptors will be discussed in a podium presentation at the Digestive Diseases Week conference, on Saturday, June 2, from 5:00 PM to 5:15 PM ET at the Walter E. Washington Convention Center, Room 140 in Washington, D.C.
The company will present preclinical data supporting the superiority of mu/delta dual agonist activities when compared to eluxadoline in treating diarrhea or abdominal pain.
Financial Results

Protagonist reported a net loss of $7.7 million for the first quarter of 2018, as compared to a net loss of $14.1 million for the same period of 2017. The decrease in net loss was driven primarily by license and collaboration revenue recognized during the first quarter of 2018, which partially offset increased research and development (R&D) expenses and increased general and administrative (G&A) expenses. The net loss for the first quarter of 2018 includes non-cash stock-based compensation of $1.2 million, as compared to $0.8 million for the same period of 2017.

License and collaboration revenue was $10.8 million for the first quarter of 2018 and consisted of revenue from activities performed under the Janssen Collaboration Agreement. Protagonist did not recognize any license and collaboration revenue for the first quarter of 2017.

R&D expenses for the first quarter of 2018 were $15.4 million, as compared to $11.3 million for the same period of the prior year. The increase in R&D expenses was primarily due to costs related to contract manufacturing, and the preparation for and conduct of PTG-100, PTG-200 and PTG-300 clinical trials. R&D expenses for the quarter also included an increase in salaries and employee-related expenses due to an increase in R&D personnel.

G&A expenses for the first quarter of 2018 were $3.6 million, as compared to $3.0 million for the same period in the prior year. The increase in G&A expense was due primarily to increases in salaries and employee-related expenses primarily due to an increase in headcount to support the growth of our operations, franchise and business related taxes and other administrative expenses.

Protagonist ended the first quarter of 2018 with $140.5 million in cash, cash equivalents and investments. The company expects current capital resources to be sufficient to fund its operations through 2019.

On May 9, 2018 Novavax, Inc., (Nasdaq:NVAX) reported its financial results for the first quarter ended March 31, 2018 (Press release, Novavax, MAY 9, 2018, View Source [SID1234526407]).

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First Quarter and Subsequent Achievements:

RSV F Vaccine

In May 2018, Novavax reached enrollment of approximately 4,600 pregnant women in its Prepare Phase 3 clinical trial of its RSV F Vaccine for infants via maternal immunization. This milestone enables Novavax to initiate a prespecified interim efficacy analysis after approximately six months of follow-up of the last infant born to the approximately 4,600 women enrolled (including 3,000 actively vaccinated women). Completion of this analysis is expected in the first quarter of 2019. Since 2015, the Prepare trial is supported by an $89 million grant from the Bill & Melinda Gates Foundation (BMGF).

In April 2018, Novavax presented at the World Vaccine Congress on the status of its Phase 3 clinical trial of its RSV F Vaccine.
NanoFlu

In April 2018, Novavax presented clinical data at the World Vaccine Congress from the Phase 1/2 clinical trial in older adults comparing trivalent formulations of NanoFlu to the market-leading licensed egg-based, high-dose influenza vaccine for older adults.

In February 2018, Novavax reported positive top-line results from its Phase 1/2 clinical trial of its trivalent NanoFlu.
Corporate

In April 2018, Novavax completed an underwritten public offering of approximately 34.8 million shares of its common stock, including 4.5 million shares pursuant to the underwriters’ option to purchase additional shares. The shares resulted in net proceeds of $54 million.

Effective on March 14, 2018, John J. Trizzino, former Senior Vice President, Commercial Operations since 2014, was promoted to Senior Vice President, Chief Business Officer and Chief Financial Officer.
Anticipated Events:

Initiation of the Phase 2 clinical trial of quadrivalent formulations of NanoFlu scheduled to begin in the third quarter of 2018.

Top-line data from the Phase 2 NanoFlu trial and End of Phase 2 meeting with the FDA expected in the first quarter of 2019.

Results of the Prepare Phase 3 interim efficacy analysis for our RSV F Vaccine expected in the first quarter of 2019.
Summary

"We had an extremely productive first quarter, including making important advances in our two lead clinical vaccine programs. We are pleased to have reached the enrollment target for our Prepare Phase 3 RSV F Vaccine trial, which clears the path for following these most recent participants and their babies, and subsequently announcing top-line results of our planned interim efficacy analysis in the first quarter of 2019," said Stanley C. Erck, President and CEO of Novavax, Inc. "We also continue to make significant progress on NanoFlu and plan to initiate a Phase 2 clinical trial in the third quarter of 2018."

Financial Results for the First Quarter Ended March 31, 2018

Novavax reported a net loss of $46.4 million, or $0.14 per share, for the first quarter of 2018, compared to a net loss of $43.9 million, or $0.16 per share, for the first quarter of 2017.

Novavax revenue in the first quarter of 2018 was $9.7 million, compared to $5.7 million in the same period in 2017. This 70% increase was driven by higher revenue recorded under the BMGF grant corresponding to the increased enrollment in the Prepare trial.

Research and development expenses increased 18% to $44.5 million in the first quarter of 2018, compared to $37.7 million for the same period in 2017. The increase was primarily due to increased development activities of the RSV F Vaccine for infants via maternal immunization.

Interest income (expense), net for the first quarter of 2018 was ($2.9) million, compared to ($3.0) million for the same period of 2017.

As of March 31, 2018, Novavax had $164.2 million in cash, cash equivalents, marketable securities and restricted cash, compared to $186.4 million as of December 31, 2017. Net cash used in operating activities for the first quarter of 2018 was $66.1 million, compared to $44.5 million for same period in 2017. The increase in cash usage was primarily due to approximately $16 million of one-time payments, as well as the adoption of a new accounting standard that requires restricted cash to be included in the beginning and ending balances on the statements of cash flows, thus increasing Novavax’ cash usage in the first quarter of 2018 and 2017 by approximately $9 million and $6 million, respectively. We expect our cash used in operating activities to significantly decrease for the subsequent quarters of 2018 as compared to the first quarter of 2018.

Conference Call

Novavax management will host its quarterly conference call today at 4:30 p.m. ET. The dial-in number for the conference call is (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 3687883. A replay of the conference call will be available starting at 7:30 p.m. ET on May 9, 2018 until 7:30 p.m. ET on May 16, 2018. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 3687883.

A webcast of the conference call can also be accessed via a link on the home page of the Novavax website at www.novavax.com or through the "Investor Info"/"Events" tab on the Novavax website. A replay of the webcast will be available on the Novavax website until August 9, 2018.

About RSV

RSV is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide, with estimated annual infection and mortality rates of 64 million and 160,000, respectively.1 In the U.S., RSV is the leading cause of hospitalization of infants.2 Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common.3 Currently, there is no approved RSV vaccine available.

About RSV F Vaccine for Infants via Maternal Immunization

Novavax is developing a vaccine that targets the fusion protein, or F protein, of the RSV virus. The F protein has highly conserved amino acid sequences, called antigenic sites, which are the target of neutralizing antibodies and are believed to be ideal vaccine targets. Novavax’ genetically engineered novel F protein antigen exposes a range of these antigenic sites, and can evoke immune responses to them in human vaccine recipients. In a previous Phase 2 clinical trial of the RSV F Vaccine, which assessed the transplacental transfer of maternal antibodies induced by the vaccine, immunized women demonstrated meaningful fold rises in anti-F IgG, palivizumab-competing antibodies and microneutralization titers. In addition, infants’ antibody levels at delivery averaged 90-100% of the mothers’ levels, indicating efficient transplacental transfer of antibodies from mother to infant.

About Influenza

Influenza is a world-wide infectious disease that causes illness in humans with symptoms ranging from mild to life-threatening or even death. Serious illness occurs not only in susceptible populations such as infants, young children and older adults, but also in the general population largely because of infection by continuously evolving strains of influenza which can evade the existing protective antibodies in humans. An estimated one million deaths each year are attributed to influenza.4 Current estimates for seasonal influenza vaccine growth in the top seven markets (U.S., Japan, France, Germany, Italy, Spain and UK), show a potential increase from approximately $3.2 billion in 2015 to $5.3 billion by 2025.5

About NanoFlu

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine candidate produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant, which has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes.