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Celldex to Report Fourth Quarter and Year-End 2017 Business/Financial Results and Present at Upcoming Investor Conference

On March 2, 2018 Celldex Therapeutics, Inc. (Nasdaq:CLDX) reported that upcoming investor events in March (Press release, Celldex Therapeutics, MAR 2, 2018, View Source [SID1234524337]).

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2017 Year-End Results and Conference Call/Webcast

Celldex will release fourth quarter and year-end 2017 financial results on Wednesday, March 7, 2018 after the U.S. financial markets close. Celldex executives will host a conference call at 4:30 p.m. EST on the same day to discuss 2017 financial and business results and to provide an update on upcoming milestones for 2018.

The conference call and presentation will be webcast live over the internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 8296067.

A replay of the call will be available approximately two hours after the live call concludes through March 15, 2018. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 8296067. The webcast will also be archived on the Company’s website.

Upcoming Investor Conference

Anthony Marucci, Co-founder, President and Chief Executive Officer, will present a corporate overview at Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today upcoming investor events in March.

2017 Year-End Results and Conference Call/Webcast

Upcoming Investor Conference

Anthony Marucci, Co-founder, President and Chief Executive Officer, will present a corporate overview at the Cowen and Company 38th Annual Health Care Conference in Boston on Monday, March 12, 2018 at 2:10 p.m. EDT.

A live webcast of the presentation will be available on the "Events & Presentations" page of the "Investors & Media" section of the Celldex website. A replay will be available for seven days following the event.

Heat Biologics Reports Fiscal Year 2017 Financial Results

On March 2, 2018 Heat Biologics, Inc. ("Heat") (Nasdaq: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported financial results for the fiscal year ended December 31, 2017 (Press release, Heat Biologics, MAR 2, 2018, View Source [SID1234524339]).

"2017 was a significant year for Heat, as we gained traction on our pipeline developments for both Heat and our subsidiary, Pelican Therapeutics," said Jeff Wolf, CEO of Heat. "Our focus for 2018 will be to continue to generate and report on data to progress HS-110 into registrational trials, advance our PTX-35 into clinical trials, and secure partnerships to enhance our efforts. We look forward to continued progress as we continue to build a leading immunotherapy company."

Fiscal Year 2017 Corporate Highlights

On December 7, 2017, we received written responses from the FDA following a Type C meeting regarding the planned registrational HS-110 clinical trial design for the treatment of non-small cell lung cancer (NSCLC). The response focused on proposed Phase 3 trial designs, both single-arm and controlled, which the FDA agreed would be appropriate to support a registrational trial of HS-110. Clinical endpoints and post-marketing commitments were also discussed in the context of accelerated approval.

On October 30, 2017, Heat subsidiary Pelican Therapeutics ("Pelican") received the second tranche in the amount of $6.5 million of its $15.2 million CPRIT grant award. The CPRIT award supports the pre-clinical development, manufacturing and clinical development of a 70-patient Phase 1 clinical trial for PTX-35.

On September 27, 2017, we announced a manufacturing agreement with KBI Biopharma, Inc. a global biopharmaceutical contract development and manufacturing organization, for cGMP production of Pelican’s PTX-35 antibody and PTX-15 fusion protein.

On May 1, 2017, we announced the completion of the acquisition of an 80 percent controlling interest in Pelican.

On March 21, 2017, we reported promising interim results for the Phase 1b portion of the trial evaluating HS-110 in combination with Bristol-Myers Squibb’s checkpoint inhibitor, nivolumab (Opdivo), for the treatment of advanced NSCLC.

2018 Additional Development

On February 27, 2018, at the 2018 Keystone Symposia Conference, Immunological Memory: Innate, Adaptive and Beyond (X1), we presented interim results from our Phase 2 study investigating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced NSCLC, whose cancers have progressed after treatment with one or more lines of therapy. Data are consistent with HS-110 mechanism-of-action, with tumor shrinkage and disease control demonstrated in a majority of evaluable patients. The HS-110 and nivolumab combination also shows durable responses in both difficult-to-treat, low TIL "cold tumor" patients, as well as low PD-L1 patients who typically do not respond to checkpoint inhibitors.

Fiscal Year 2017 Financial Highlights

Total operating expenses increased 10.4% to $14.9 million, compared to $13.5 million for the year ended December 31, 2016. For the year ended December 31, 2017, operating expenses are primarily comprised of research and development, general and administrative expenses, as well as change in the fair value of contingent consideration due to the Company’s acquisition of 80% controlling interest in Pelican during the year.

Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea

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.

"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.

TG Therapeutics, Inc. to Present at Upcoming Investor Conferences

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:

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.

Reata Pharmaceuticals, Inc. Announces Fourth Quarter and Full Year 2017 Financial and Operating Results

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]).

"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.