On March 5, 2018 Kitov Pharmaceuticals (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, reported that it filed its Annual Report for 2017 on Form 20-F, including its full financial results for the year ended December 31, 2017 (Press release, Kitov Pharmaceuticals , MAR 5, 2018, View Source [SID1234524417]).

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Kitov also today released a Letter from Chief Executive Officer, Isaac Israel, regarding recent activities and plans:

"Dear Shareholders,

Following the publication of our Annual Report for 2017, I would like to share with you our major accomplishments during 2017 and our plans and expectations for 2018.

HIGHLIGHTS OF 2017:

Consensi

Our team made important progress on our lead drug candidate, Consensi (which we formerly referred to as KIT-302).

Consensi, a combination drug that simultaneously treats pain caused by osteoarthritis and treats hypertension, is comprised of two FDA approved drugs, celecoxib (Celebrex), an NSAID, for the treatment of pain caused by osteoarthritis, and amlodipine besylate (Norvasc), a drug designed to treat hypertension. Hypertension is one of the side effects of using non-steroidal anti-inflammatory drugs, or NSAIDs, including celecoxib. Approximately 50% of the patients suffering from osteoarthritis in the US also suffer from hypertension, so industry sources estimate there are millions of patients that suffer from both conditions.

We made advances in several important areas:

Regulatory: The FDA filed our New Drug Application (NDA) for Consensi, following our submission of the NDA. We are very proud of the high-quality NDA package that was filed by the FDA. The FDA has set a PDUFA date of May 31, 2018 for Consensi.

Positive Clinical Trial Results: We announced the top-line results of our Phase III/IV randomized double-blind, placebo-controlled renal function clinical trial for Consensi. These results successfully validated the primary efficacy endpoint of our earlier successfully completed Phase III clinical trial. As such, we now have additional clinical evidence that establishes that adding celecoxib to amlodipine does not impair the blood pressure lowering effects of amlodipine. The trial also increased the total number of patients treated with Consensi, which we believe could increase the probability of ultimately receiving marketing approval for Consensi from the FDA.

Moreover, the Phase III/IV study strengthened the clinical evidence of the positive effect of Consensi on kidney function, which could provide us with a significant marketing advantage in the future.

Most importantly, we have advanced towards our goal of providing a safer NSAID, with the potential to be the first and only NSAID in the market which is both effective in lowering blood pressure and reduces the risk of kidney damage.

Commercial Partnership: We signed a definitive License Agreement for Consensi with Kuhnil Pharmaceutical Co. Ltd., a leading South Korean pharmaceutical company, for the territory of South Korea. Kuhnil will bear responsibility for and the costs of seeking regulatory approval for Consensi in South Korea. Under the terms of the agreement, we are entitled to receive payments upon achievement of certain predefined regulatory milestones, as well as double-digit royalties on net sales. Our relationship with Kuhnil and preparations for commercial launch in South Korea are proceeding as planned, and we have received our first milestone payment from Kuhnil.

South Korea is an important, attractive, gateway market into Asia, and we are very pleased with our choice of Kuhnil, which has the organizational and marketing infrastructure and capabilities for a successful commercial launch, which is expected to occur in 2019.

Patent Protection: We received a Notice of Allowance from the U.S. Patent & Trademark Office (USPTO) related to claims expanding the patent coverage of Consensi to include oral dosage compositions containing both amlodipine and celecoxib. The Notice of Allowance should result in the issuance of an additional patent that would further strengthen Kitov’s proprietary position and long-term U.S. market exclusivity for Consensi.

TyrNovo: NT219 – Small molecule oncology drug

We acquired a majority stake in TyrNovo, a private oncology company, which is developing NT219, a small molecule drug that presents a new and exciting concept in cancer therapy by attempting to address a major problem whose solution has been elusive to date – tumors’ developing cancer-drug resistance. NT219 is a unique compound that is designed to prevent and reverse resistance to anti-cancer drugs through dual inhibition of STAT3 and IRS1/2, two signal pathways associated with drug resistance. Kitov’s current ownership in TyrNovo is 65% and we have a pending transaction to increase our stake in TyrNovo to approximately 92%, expected to be closed in the next few weeks.

We are very pleased with this acquisition, its progress during 2017 and, most importantly, its long-term potential. NT219 has demonstrated impressive efficacy in large array of pre-clinical models with several leading targeted oncology drugs, with chemotherapy drugs and with Immuno-Oncology drugs in various cancer types, including in combination with Keytruda. Our development program is of critical importance, as we prepare for the start of human clinical trials in 2019.

Furthermore, we received the FDA’s response to NT219’s pre-IND meeting package. In its response, the FDA agreed to our preclinical and clinical development plans for NT219, and we are considering the initiation of clinical studies in combination with gemcitabine (Gemzar) for the treatment of pancreatic cancer and/or in combination with osimertinib (TagrissoTM) for the treatment of non-small cell lung cancer (NSCLC).

Our goal is to develop NT219 in combination with approved oncology drugs to increase efficacy, expand target populations and treatment duration. Our long-term strategy is to develop NT219 in combination with other oncology drugs and for additional oncology indications, on our own or in collaboration with potential strategic partners. Our preliminary partnering discussions for NT219 have yielded positive feedback, and this will be a focus area for TyrNovo throughout 2018.

OUTLOOK FOR 2018

Our major goals for 2018 are:

●To submit to the FDA our study report for the recently completed Phase III/IV renal function clinical trial for Consensi. We believe the clinical study report is of major significance in that it could strengthen the drug’s labeling and support future marketing of Consensi.

●Receive marketing approval for Consensi from the FDA.

●To successfully expand our business development efforts for Consensi by entering into additional distribution or licensing agreements in the U.S. and other target markets, with an emphasis on China and other countries in Asia.

●Make significant progress towards finalizing the submission of an IND application for NT219 to the FDA in order to pave the way for the start of clinical trials in 2019.

●Continue to strengthen our patent protection for both Consensi and NT219 through the submission of various patent applications and the expansion of our existing patent families.

I want to thank you, our shareholders, for the trust you have placed in us. Our board of directors and management team is committed to continuing to unlock the substantial value in our business by leveraging our team’s deep regulatory expertise and drug development experience, complemented by targeted business development efforts, in order to maximize the potential of our therapeutic candidates.

This past year has taught us all at Kitov a great deal about our team’s special human qualities and its determination, dedication, and commitment to face any challenge.

We look forward to providing you with further updates on our continued progress throughout 2018.

Best wishes for a successful year.

Kind regards,
Mr. Isaac Israel
Chief Executive Officer"

On March 2, 2018 Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (Reata or Company), a clinical-stage biopharmaceutical company, reported financial results for the fourth quarter and full year ended December 31, 2017, and provided an update on the Company’s business and product development programs (Press release, Reata Pharmaceuticals, MAR 2, 2018, View Source;p=RssLanding&cat=news&id=2335885 [SID1234524342]).

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"In 2017, Reata made significant strides towards our goal of building a deep pipeline of late-stage therapeutics for rare and life-threatening diseases," said Warren Huff, Chief Executive Officer. "We entered 2017 with one pivotal trial in pulmonary arterial hypertension associated with connective tissue disease and a broad portfolio of exploratory Phase 2 studies from which we produced meaningful clinical data and launched pivotal trials in two additional rare diseases, Alport syndrome and Friedreich’s ataxia. We begin 2018 with these three pivotal programs in the clinic and a highly focused Phase 2 program in four rare forms of CKD underway."

Pipeline Highlights

In 2017, we launched and completed the Phase 2 portion of the Phase 2/3 CARDINAL study for bardoxolone methyl in patients with CKD caused by Alport syndrome. In the Phase 2 clinical trial, bardoxolone methyl demonstrated a statistically significant, mean increase from baseline in kidney function, as assessed by eGFR, at the 12 week endpoint. On the basis of the Phase 2 results, we initiated the Phase 3 portion of the CARDINAL trial, which will enroll approximately 150 patients with Alport syndrome. The United States Food and Drug Administration (FDA) has provided guidance that one year data from the ongoing Phase 3 portion of the trial demonstrating an improvement in retained eGFR, which is the increase in eGFR versus placebo after the patients have been taken off drug for four weeks, may support accelerated approval for bardoxolone methyl.

We began the Phase 2 PHOENIX study in patients with autosomal dominant polycystic kidney disease, IgA nephropathy, type 1 diabetic CKD, and focal segmental glomerulosclerosis. Each cohort will enroll approximately 25 patients to evaluate the safety and efficacy of bardoxolone methyl treatment for each rare form of CKD. Enrollment has begun in the trial for each of the four rare forms of CKD.

We reported positive proof-of-concept data in the MOXIe trial of omaveloxolone in Friedreich’s ataxia, and we began the registrational portion of MOXIe in 2017. Omaveloxolone demonstrated a statistically significant improvement in modified Friedreich’s Ataxia Rating Scale (mFARS) scores of 3.8 points (p=0.0001) at the optimal dose level versus baseline, and a placebo-corrected improvement in mFARS scores of 2.3 points (p=0.06) in Part 1 of the MOXIe trial. The FDA has confirmed that mFARS is acceptable as the primary endpoint for part 2 of MOXIe and that it may consider either accelerated or full approval based upon the overall results of the trial and strength of the data.

Anticipated Clinical Milestones in 2018 and 2019

One year retained eGFR benefit data for CARDINAL Phase 2 patients in the third quarter of 2018
12 week eGFR data from one or more cohorts of PHOENIX in the second half of 2018
CATALYST Phase 3 data in the second half of 2018, pending a sample size re-calculation in the second quarter of 2018 that could change expected timing
CARDINAL Phase 3 data in the second half of 2019
Data from the registrational part 2 of MOXIe in the second half of 2019
Fourth Quarter Results

The Company incurred operating expenses of $26.5 million for the quarter ended December 31, 2017, with research and development accounting for $20.4 million. This compares to operating expenses of $16.7 million for the same period of the year prior, when research and development accounted for $11.8 million. A net loss of $16.7 million was reported by the Company for the quarter ended December 31, 2017, equating to a loss of $0.64 per share, compared to net loss of $4.1 million or $0.19 per share in the same period of the year prior.

2017 Financial Results

As of December 31, 2017, the Company had $129.8 million in cash and cash equivalents. We believe our existing cash and cash equivalents, in combination with available debt and an expected milestone from Kyowa Hakko Kirin, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements, assuming the CATALYST sample size re-calculation does not result in a sample size at the high end of the range, through registrational data from CATALYST in 2018, and both CARDINAL and MOXIe in the second half of 2019.

The Company incurred operating expenses of $95.0 million for the 12 months ended December 31, 2017, with research and development accounting for $71.3 million. This compares to operating expenses of $56.7 million for the same period of the year prior, when research and development accounted for $39.5 million. The 67% increase in operating expenses was primarily due to an 81% research and development expense increase consisting of $23.9 million in expanded clinical and manufacturing activities, primarily for CARDINAL, CATALYST, MOXIe, the extension trial for CATALYST and LARIAT and PHOENIX as well as increased costs in other clinical and preclinical programs. A net loss of $47.7 million was reported by the Company for the 12 month period ended December 31, 2017, equating to a loss of $1.99 per share, compared to net loss of $6.2 million or $0.31 per share in the year prior. The increased net loss was primarily due to the increased operating expenses and a decrease in the amount of deferred revenue recognized in 2017.

On March 2, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported that the Company’s fourth quarter 2017 financial results will be released on Thursday, March 8, 2018 (Press release, Calithera Biosciences, MAR 2, 2018, View Source [SID1234535245]). Company management will host a conference call on Thursday, March 8, 2018 at 1:30 p.m. Pacific Time/ 4:30 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.

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The press release and live audio webcast can be accessed via the Investor section of the Company’s website at www.calithera.com. The conference call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and refer to conference ID 3398144. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on Calithera’s website for 30 day

On March 2, 2018 TG Therapeutics, Inc. (NASDAQ:TGTX) reported that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will be presenting at two upcoming investor conferences (Press release, TG Therapeutics, MAR 2, 2018, View Source [SID1234524343]). Presentation details are as follows:

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The Raymond James & Associates’ 39th Annual Institutional Investors Conference, being held at the JW Marriott Orlando Grande Lakes in Orlando, Florida. The presentation is scheduled to take place on Tuesday March 6, 2018 at 2:50pm ET.
The Cowen 38th Annual Health Care Conference, being held at the Boston Marriott Copley Place in Boston, Massachusetts. The presentation is scheduled to take place on Monday March 12, 2018 at 1:30pm ET.
A live webcast of each presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com.

On March 2, 2018 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the U.S. Food and Drug Administration (FDA) has accepted for filing with standard review the company’s New Drug Application (NDA) seeking marketing approval for solriamfetol, an investigational medicine for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA) (Press release, Jazz Pharmaceuticals, MAR 2, 2018, View Source;p=RssLanding&cat=news&id=2335912 [SID1234524340]). The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is December 20, 2018.

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"We believe this medicine will provide a meaningful option for patients living with excessive sleepiness due to narcolepsy or OSA, and we look forward to working with the FDA during the review process for solriamfetol," said Karen Smith, M.D., Ph.D., executive vice president, research and development and chief medical officer at Jazz Pharmaceuticals. "Jazz continues to invest in ongoing research, education and advocacy on behalf of the sleep community, including studying solriamfetol for the treatment of excessive sleepiness in other areas of unmet need, such as Parkinson’s disease."

The solriamfetol Phase 3 clinical program includes one study evaluating excessive sleepiness in adult patients with narcolepsy (TONES 2), two studies evaluating excessive sleepiness in adult patients with OSA (TONES 3 and TONES 4), and an open-label, long-term safety and maintenance of efficacy study (TONES 5) in the treatment of excessive sleepiness in patients with narcolepsy or OSA.

About OSA and Excessive Sleepiness
OSA is a prevalent disease (as high as 14% in men and 5% in women) with excessive sleepiness being a major presenting complaint in many cases.1-2 Excessive sleepiness in OSA is associated with impairments in cognitive function, safety, productivity, interpersonal relationships, and overall quality of life. Positive Airway Pressure (PAP) therapy, with its most common form being Continuous Positive Airway Pressure (CPAP), has been shown to be an effective therapy for sleep-related airway obstruction, with frequent improvement in excessive sleepiness in many patients; however, not all patients tolerate CPAP therapy and among those who tolerate CPAP, usage is highly variable. It is estimated that excessive sleepiness persists in 13%–65% of people utilizing CPAP for OSA.3-5

About Narcolepsy
Narcolepsy is a debilitating neurological disorder characterized by excessive sleepiness, and the inability to regulate sleep-wake cycles normally.6 It affects an estimated one in 2,000 people in the United States, with symptoms typically appearing in early adulthood. It is estimated that more than 50% of patients with narcolepsy have not been diagnosed.7 Studies have shown it may take 10 years or more for people with narcolepsy to receive a correct diagnosis.8 Excessive sleepiness is the primary symptom of narcolepsy and is present in all people with the disorder.2 Excessive sleepiness is characterized by the inability to stay awake and alert during the day resulting in unplanned lapses into sleep or drowsiness.2,7,9

About Solriamfetol (JZP-110)
Solriamfetol (JZP-110) is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in development for treatment of excessive sleepiness in adult patients with narcolepsy, OSA, and Parkinson’s disease. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia. SK Biopharmaceuticals, the discoverer of the compound (also known as SKL-N05), maintains rights in 12 Asian markets, including Korea, China and Japan. Solriamfetol has orphan drug designation in the United States for narcolepsy.