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]).

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"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.

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

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 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.

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 has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Heat Biologics, 2018, MAR 2, 2018, View Source [SID1234524338]).

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On March 1, 2018 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a leader in less invasive medical devices for bariatric and gastrointestinal procedures, reported financial results for the fourth quarter and year ended December 31, 2017 (Press release, Lpath, MAR 1, 2018, View Source [SID1234524307]).

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Fourth Quarter 2017 Highlights
•
GAAP total revenues increased 5% over the fourth quarter of 2016
•
Non-GAAP adjusted total revenues, which excludes U.S. Orbera starter kit sales, increased 9% over the fourth quarter of 2016
•
Total Endo-bariatric sales of $9.8 million, up 29% over the fourth quarter of 2016
Full Year 2017 Highlights
•
GAAP total revenues of $64.3 million in 2017 compared to $64.7 million in 2016
•
Non-GAAP adjusted total revenues, which excludes U.S. Orbera starter kit sales, increased 5% over 2016
•
Endo-bariatric sales of $35.9 million, up 13% over 2016
Todd Newton, CEO of Apollo, said, "The fourth quarter marks our second consecutive quarter of consolidated total revenue growth on the sales of our Endo-bariatric products especially in our international markets. Demand for OverStitch was especially strong during the fourth quarter in all markets as the treatments possible with this new technology gained physician adoption. Our Endo-bariatric product sales are now 60% of our total sales and we look to build on this momentum in 2018."
Fourth Quarter 2017 Results
Total revenues in the fourth quarter of 2017 were $16.1 million, compared to $15.3 million in the fourth quarter 2016, an increase of 5%.
Total Endo-bariatric sales increased 29% to $9.8 million in the fourth quarter of 2017 compared to $7.6 million in the fourth quarter of 2016, due to a 64%, or $2.5 million, increase in Endo-bariatric product sales outside the U.S. ("OUS") as a result of higher OverStitch sales in our direct markets and the introduction of Orbera365 in Europe. OUS direct market sales were 64% of total OUS Endo-bariatric product sales in the fourth quarter of 2017, compared to 59% in the fourth quarter of 2016. In the U.S., total Endo-bariatric product sales declined 7%, or $0.3 million in the fourth quarter of 2017 compared to the same quarter of 2016. Excluding U.S. Orbera starter kit sales, U.S. Endo-bariatric product sales increased 8%, or $0.2 million for the fourth quarter of 2017 due to higher physician adoption and utilization of OverStitch products.
Total Surgical product sales in the fourth quarter 2017 were $6.2 million, a decrease of just under 20%, compared to $7.6 million in the fourth quarter of 2016. Total OUS Surgical sales decreased 12% to $2.1 million for the fourth quarter of 2017 compared to $2.3 million for the fourth quarter of 2016. In the U.S., Surgical sales decreased 23% to $4.1 million for the fourth quarter of 2017 compared to $5.3 million for the fourth quarter of 2016.
Gross margin for the fourth quarter of 2017 was 58%, compared to 62% for the fourth quarter of 2016 as a result of a greater proportion of our overall product sales coming from our Endo-bariatric products, which realize a lower gross margin than our Surgical products. Additionally, the mix of Apollo manufactured products sold increased in the fourth quarter of 2017 resulting in more overhead charged as cost of goods sold compared to the fourth quarter of 2016 when we were depleting the inventory we purchased as part of the planned transition from Allergan to Apollo. We expect gross margin to improve as we complete certain identified Endo-bariatric product gross margin improvement projects and improve capacity utilization of our manufacturing facility over the next two years.
Total operating expenses were $15.2 million in the fourth quarter of 2017, compared to $17.2 million in the fourth quarter of 2016 primarily due to decreased general and administrative expenses related to transaction costs incurred in the fourth quarter of 2016 associated with the Lpath merger.

Interest expense for the fourth quarter of 2017 decreased $10.3 million when compared to the fourth quarter of 2016. This decline was largely due to non-cash charges associated with convertible notes that were exchanged for common stock in connection with the Lpath merger in the fourth quarter of 2016.
Net loss for the fourth quarter 2017 was $7.3 million compared to $19.7 million for the fourth quarter 2016.
Full Year 2017 Financial Results
Total revenues for 2017 were $64.3 million, compared to $64.7 million in 2016.
Total Endo-bariatric sales increased 13% to $35.9 million in 2017, compared to $31.9 million in 2016, comprising 56% of total revenue in 2017 compared to 49% in 2016. Excluding U.S. Orbera starter kit sales, total Endo-bariatric sales increased 27% for the year. Total OUS Endo-bariatric product sales increased 32%, or $5.2 million in 2017 compared to 2016, primarily due to higher OverStitch sales in our direct markets. OUS direct market sales were 69% of total OUS Endo-bariatric product sales in 2017 compared to 65% for 2016. U.S. Endo-bariatric product sales for 2017 decreased 8%, or $1.2 million when compared to 2016. Excluding U.S. Orbera starter kit sales, U.S. Endo-bariatric product sales increased 20%, or $2.3 million in 2017 primarily due to higher OverStitch product sales and higher Orbera product sales from the first half of 2017.
Total Surgical product sales in 2017 were $27.6 million, a decrease of 15%, compared to $32.3 million in 2016. Total OUS Surgical product sales decreased 5% to $10.2 million in 2017 compared to $10.7 million in 2016. In the U.S. Surgical sales decreased 20% to $17.4 million in 2017 compared to $21.6 million in 2016.
Gross margin increased to 62% for 2017 from 61% in 2016. Cost of sales included inventory impairment charges of $0.7 million and $3.8 million for 2017 and 2016, respectively. In 2016, we recorded an inventory impairment charge related to expiring finished good inventory and excess raw materials transferred from Allergan as required under the transition services agreement. Excluding inventory impairment charges, gross margin was 63% for 2017 and 67% for 2016. This lower gross margin, excluding the impact of inventory impairment charges, is due to the ongoing shift in our product sales mix from higher margin Surgical products to Endo-bariatric products that realize lower relative gross margins and the shift in the mix of Apollo manufactured products sold as discussed above in fourth quarter results.
Total operating expenses were $62.2 million in 2017, compared to $60.2 million in 2016 primarily due to higher sales and marketing expenses associated with our Endo-bariatric product sales growth.
Interest expense decreased $13.7 million in 2017, compared to 2016 mainly due to the elimination of non-cash charges associated with the convertible notes that were exchanged for common stock.
Net loss for 2017 was $27.3 million compared to $41.2 million for 2016.
Cash, cash equivalents and restricted cash were $31.4 million as of December 31, 2017.
Capitalization Update
On December 4, 2017, we filed a registration statement on Form S-3 to offer and sell up to a maximum amount of $50.0 million of common stock and entered a sales agreement to sell up to $16.0 million of shares of those shares in an "at-the-market" program.
Conference Call
Apollo will host a conference call on Thursday, March 1, 2018 at 3:30 p.m. Central Time / 4:30 p.m. Eastern Time to discuss Apollo’s operating results for the fourth quarter and year ended December 31, 2017.
To participate in the conference call dial (888) 394-8218 for domestic callers and (323) 701-0225 for international callers. The conference ID number is 8902763. A live webcast of the conference call will be made available on the "Events and Presentations" section of our Investor Relations website: www.ir.apolloendo.com.
A replay of the webcast will remain available on Apollo’s website, www.apolloendo.com, until Apollo releases its first quarter 2018 financial results. In addition, a telephonic replay of the call will be available until March 8, 2018. The replay dial-in numbers are (844) 512-2921 for domestic callers and (412) 317-6671 for international callers. The replay conference ID number is 8902763. A transcript of the earnings call will be made available on the "Events and Presentations" section of our Investor Relations website: www.ir.apolloendo.com.

Non-GAAP Financial Measures
To supplement to our financial results we are providing a non-GAAP financial measure, adjusted total revenues which exclude U.S. Orbera starter kit sales. This supplemental measure of our performance is not required by, and is not determined in accordance with, GAAP.
Non-GAAP financial information is not a substitute for any financial measure determined in accordance with GAAP and should be read only in conjunction with Apollo’s condensed consolidated financial statements prepared in accordance with GAAP. Apollo’s management uses certain supplemental non-GAAP financial measures internally to understand, manage and evaluate Apollo’s business, and make operating decisions. Reconciliations for each non-GAAP financial measure to its most directly comparable GAAP financial measure is provided in the tables below. Management believes that making non-GAAP financial information available to investors, in addition to GAAP financial information, may facilitate more consistent comparisons between the company’s performance over time with the performance of other companies in the medical device industry, which may use similar financial measures to supplement their GAAP financial information.

On March 1, 2018 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), reported that fostamatinib data from its FIT Phase 3 extension study (FIT3) in patients with chronic immune thrombocytopenia (ITP) and preliminary data from its SOAR Phase 2 clinical study in patients with warm antibody autoimmune hemolytic anemia (AIHA) will be presented at the 4th Biennial Summit of the Thrombosis & Hemostasis Societies of North America on March 8 – 10, 2018 in San Diego, CA (Press release, Rigel, MAR 1, 2018, View Source;p=RssLanding&cat=news&id=2335578 [SID1234524328]).

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Fostamatinib disodium is an oral investigational drug candidate designed to inhibit spleen tyrosine kinase (SYK), a key signaling component of the body’s immune process that leads to platelet destruction in ITP and red blood cell destruction in AIHA. SYK inhibition by fostamatinib can affect antibody-mediated platelet destruction, an underlying cause of ITP. Fostamatinib may also impair antibody-mediated red blood cell destruction in AIHA, a rare disease for which there are no approved therapies.

Fostamatinib Oral Presentation
Date and Time: Saturday, March 10, 10:15am PT
Location: Marriott Grand Ballroom 10, Marriott Marquis, San Diego
Title: Platelet Responses in Placebo Patients with Long-Duration Chronic Immune Thrombocytopenia Initiating Fostamatinib in the 049 Open-Label Extension Study

Fostamatinib Poster Presentation
Date and Time: Thursday, March 8, 3:30-4:15pm PT
Location: Pacific Ballroom, Marriott Marquis, San Diego
Title: Fostamatinib, a Spleen Tyrosine Kinase Inhibitor, is Active in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia: Results of the SOAR Phase 2, Multicenter, Open-Label Study
ePoster #35 (Electronic poster)

About ITP
In patients with ITP, the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPOs) and splenectomy. However, not all patients are adequately treated with existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About AIHA
Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body’s own red blood cells. AIHA affects approximately 40,000 adult patients in the US and can be a severe, debilitating disease. To date, there are no FDA approved disease-targeted therapies for AIHA, despite the tremendous medical need that exists for these patients.