On March 26, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported its financial results for the full year ended December 31, 2019 and provided a business update (Press release, Phio Pharmaceuticals, MAR 26, 2020, View Source [SID1234555871]).

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"Our progress in 2019, along with the bolstering of our balance sheet, now positions us to further unlock the value of our immuno-oncology programs based on our self-delivering RNAi (INTASYL) therapeutic platform," said Dr. Gerrit Dispersyn, President and CEO of Phio. "With new data from animal studies becoming available, we look forward to continuing our R&D momentum in 2020, including the transition towards the clinical development stage of our lead candidate PH-762. We also continue to leverage our RNAi platform to establish research collaborations with leading companies and academic institutions. We recently announced a new collaboration and option agreement with Medigene AG, further building on our previously announced research collaboration with the Helmholtz Zentrum München to design and develop novel candidates in adoptive cell therapy."

Year in Review and Recent Corporate Updates

Pipeline

·Phio has developed a product platform based on our INTASYL technology that allows easy, precise, rapid and selective non-genetically modified programming of cells. It can be used to improve immune cells used in adoptive cell transfer (ACT therapy) and to reduce immunosuppression in the tumor microenvironment (TME). The use of INTASYL to improve ACT can be done ex vivo, during cell manufacturing. The direct therapeutic use of INTASYL compounds towards the TME can be done in vivo by local delivery to the tumor in the patient. Both applications of our INTASYL technology result in improved immunotherapy.

·Lead product candidate PH-762 is designed to elicit checkpoint blockade by inhibiting PD-1 receptor expression in T cells. Recent data developed in-house and with our collaborators, has shown that PH-762 can elicit PD-1 checkpoint blockade by silencing PD-1 receptor expression resulting in enhanced T cell activation and tumor cytotoxicity, and shows the potential of PH-762 in both ACT and TME applications. The Company expects that PH-762 can be ready to enter the clinic with a partner in ACT therapy in the second half of 2020, and for direct therapeutic use towards the TME through intra-tumoral injection in 2021.

·The Company’s next pipeline product, PH-804, is designed to silence the expression of the immune exhaustion target TIGIT by NK cells and T cells resulting in them becoming "weaponized." Phio has shown that reduction of TIGIT by PH-804 leads to an increase in the cytotoxic capacity of NK cells. In addition, in recent in vivo studies by the Company it was shown that intra-tumoral injections of a mouse version of PH-804 reduced the tumor growth in colorectal carcinoma tumor bearing mice. The Company is developing PH-804 with the aim to enter the clinic with a partner in ACT therapy in 2021.

R&D Collaborations

·Entered into a new collaboration and option agreement with Medigene AG ("Medigene") in relation to the previously announced research collaboration with the Helmholtz Zentrum München for the design and development of new targets based on Phio’s INTASYL platform for use in cancer immunotherapies.

·Expanded on a collaboration with the Karolinska Institutet to further develop self-delivering RNAi immunotherapies for treating solid tumors and build on the exciting results with several compounds in both T cells and NK cells developed under the previous agreement.

·Entered into a research collaboration with the Helmholtz Zentrum München for the design and development of new targets based on Phio’s INTASYL platform for use in cancer immunotherapies.

·Entered into a research collaboration with Carisma Therapeutics to evaluate the potential of Phio’s technology to enhance the immune function of Carisma’s chimeric antigen receptor macrophages (CAR-M) as a novel adoptive cell therapy for use in cancer treatment.

·Entered into a research collaboration with Glycostem Therapeutics BV to explore the potential synergies of using our INTASYL in combination with Glycostem’s proprietary Natural Killer-cell (NK-cell) generation technology (oNKord). The goal of the collaboration is to develop cellular immunotherapies for cancer treatment with enhanced efficacy and/or safety, resulting in further improvement of Glycostem’s cellular immunotherapies for the treatment of cancer patients.

Conference Presentations and Poster Exhibits

·Presented a corporate update at the Biotech Showcase 2020 in January 2020. The presentation highlighted the Company’s in vivo study result with PH-804. The in vivo studies showed that intra-tumoral injections of a mouse version of PH-804 reduced the tumor growth in colorectal carcinoma tumor bearing mice. This was shown to be correlated with the silencing of TIGIT messenger RNA expression and an increase in cytotoxic effector cells in the tumor micro-environment.

·Presented three posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Annual Meeting. The presentation highlighted the Company’s proprietary INTASYL technology for "weaponizing" T cells against cancer reflecting internal work and the Company’s collaborations with Iovance Biotherapeutics and the Karolinska Institutet.

·Presented a poster "Feasibility and efficacy using self-delivering RNAi against TGFB1 to reduce TME immunosuppression" at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019.

Organizational

·Appointed Gerrit Dispersyn, Dr. Med. Sc. as the Company’s President and Chief Executive Officer.

Financial Results

Cash Position

At December 31, 2019, the Company had cash of $6.9 million as compared with $14.9 million at December 31, 2018. This does not include the $9.74 million in gross proceeds the Company raised through two equity offerings completed in February 2020. The Company expects its cash will be sufficient to fund currently planned operations for at least the next 12 months.

Research and Development Expenses

Research and development expenses were approximately $4.3 million for the years ended December 31, 2019 and 2018, respectively. Research and development expenses were consistent year over year primarily as a result of a reduction in the Company’s legacy clinical trial-related expenses which ended in 2018; offset by increased use of third-party CROs to support preclinical immuno-oncology research efforts in 2019.

General and Administrative Expenses

General and administrative expenses were $4.7 million for the year ended December 31, 2019, compared to $3.2 million for the year ended December 31, 2018. The increase was primarily due to legal professional fees, recruiting fees related to employee hiring activities and increased proxy-related fees as a result of the Company’s annual and special stockholder meetings held in 2019.

Net Loss

Net loss was $8.9 million or $19.33 per share for the year ended December 31, 2019, compared with $7.4 million or $57.46 per share for the year ended December 31, 2018. The increase was primarily attributable to an increase in operating expenses, discussed above.

On March 26, 2020 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders, reported financial results for the fourth quarter and full-year ended December 31, 2019 and provided an update on its clinical development programs (Press release, Equillium, MAR 26, 2020, View Source [SID1234555870]).

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"COVID-19 and the global response to combat this pandemic may have unprecedented consequences to the healthcare system, including the ability to conduct clinical studies," said Bruce Steel, chief executive officer of Equillium. "In an abundance of caution to protect patients, caregivers, clinical site staff, company employees and contractors at this critical juncture, we have paused enrollment in the EQUIP trial for uncontrolled asthma and the EQUALISE trial for lupus nephritis. Our decision was not based on any safety events related to itolizumab and is in alignment with the FDA’s guidance on the conduct of clinical trials during the COVID-19 pandemic issued March 20, 2020. The demands on medical institutions and the ability of clinicians to execute clinical studies during this global crisis were also considerations in our decision. As a result, we are suspending guidance on when we anticipate reporting initial data from these studies. We will continue to monitor the situation and are working closely with our partners and focusing on being operationally prepared to restart these trials when appropriate."

"We are continuing to enroll patients in the EQUATE study for patients with acute graft-versus-host disease (aGVHD) given the acute life-threatening severity of the disease. We are maintaining guidance that we anticipate reporting initial data from the EQUATE study during the second half of 2020. We also reiterate guidance that our cash on hand is sufficient to fund operations into the second half of 2021; this runway may be extended depending on the timing of restarting enrollment of the EQUIP and EQUALISE trials."

"We have made significant advances over the last year in the development of itolizumab in multiple indications. We eagerly await initial results from our aGVHD study where we believe itolizumab represents a potentially life-saving treatment for these severely ill patients. Additionally, depending on the course of COVID-19, we look forward to recommencing our studies in lupus nephritis and uncontrolled asthma to elucidate the potential of itolizumab as a novel therapeutic option for patients across a range of severe immuno-inflammatory diseases."

2019 Business Highlights:

Initiated three Phase 1b proof-of-concept clinical trials of itolizumab:

EQUATE trial in aGVHD

EQUIP trial in uncontrolled asthma

EQUALISE trial in lupus nephritis

Received fast track designation from the Food and Drug Administration (FDA) for the treatment with itolizumab in patients with aGVHD and lupus nephritis

Received orphan drug designations from the FDA for both the prevention and treatment of aGVHD

Expanded exclusive license agreement with Biocon Limited for itolizumab to include the territories of Australia and New Zealand, and obtained exclusive representation rights to third-party licensing rights to develop and commercialize itolizumab in select major markets outside of North America

Secured a term debt facility for up to $20 million with Silicon Valley Bank and Oxford Finance LLC

Upcoming Catalysts:

Initial data from the Phase 1b part of the EQUATE trial in aGVHD expected in 2H 2020

Fourth Quarter 2019 Financial Results

Research and development (R&D) expenses. Total R&D expenses for the three months ended December 31, 2019 were $5.4 million, compared with $2.5 million for the same period in 2018. The increase in R&D expenses was primarily driven by the ramp-up of clinical development activities associated with the EQUIP, EQUATE and EQUALISE clinical trials, increased headcount expenses, and preclinical research and translational science activities to support Equillium’s clinical development programs.

General and administrative (G&A) expenses. Total G&A expenses for the three months ended December 31, 2019 were $2.2 million, compared with $1.7 million for the same period in 2018. The increase in G&A expenses was primarily driven by additional costs related to increased headcount expenses, costs related to being a public company, offset by lower legal fees.

Net loss. Net loss for the three months ended December 31, 2019 was $7.6 million, or $(0.44) per basic and diluted share, compared with a net loss of $5.0 million, or $(0.31) per basic and diluted share for the same period in 2018.

Full-Year 2019 Financial Results

Research and development (R&D) expenses. Total R&D expenses for the year ended December 31, 2019 were $17.6 million, compared with $4.9 million for the year ended December 31, 2018. The increase in R&D expenses was primarily driven by the initiation and ramp-up of clinical development activities associated with the EQUIP, EQUATE and EQUALISE clinical trials, increased headcount expenses, and preclinical research and translational science activities to support Equillium’s clinical development programs.

General and administrative (G&A) expenses. Total G&A expenses for the year ended December 31, 2019 were $9.1 million, compared with $3.7 million for the year ended December 31, 2018. The increase in G&A expenses was primarily driven by additional costs related to increased headcount expenses, costs related to being a public company, and legal and other professional fees.

Net loss. Net loss for the year ended December 31, 2019 was $25.6 million, or $(1.47) per basic and diluted share, compared with a net loss of $13.3 million, or $(1.09) per basic and diluted share for the year ended December 31, 2018.

Cash, cash equivalents and short-term investments. Equillium held cash, cash equivalents and short-term investments totaling approximately $53.1 million at December 31, 2019, compared to $65.9 million at December 31, 2018.

On March 26, 2020 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology company developing next-generation antisense oligonucleotide (ASO) therapies using its scalable PATrOL platform to address genetic diseases, reported its financial results for the three month period ended December 31, 2019 (Press release, Ohr Pharmaceutical, MAR 26, 2020, View Source [SID1234555869]).

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"We continue to advance the development of our neurological and neuromuscular programs, which have not been significantly impacted by the COVID-19 pandemic. Next week, we plan to announce the results from a pharmacokinetic study in non-human primates, as well as pharmacodynamic data in patient-derived cell lines. We also expect to receive additional data from in vivo mouse pharmacokinetic studies later in the second calendar quarter of 2020 and present those results in a peer-reviewed publication or at a scientific conference in the second half of the calendar year," said Dietrich A. Stephan, Ph.D., chief executive officer of NeuBase.

"Recent FDA approvals in the RNA therapeutics industry continue to confirm the broad utility of the gene silencing approach, with neutral backbone ASOs now representing a significant portion of approved RNA-based drugs. We believe that the differentiated features of our PATrOL platform bodes well for our participation in the industry as we help fulfill the promise of scalable drug development using genetic sequence-based drugs. As previously announced, we plan to initially focus on Huntington’s disease and myotonic dystrophy to address the critical unmet needs of the patients impacted by these diseases, and then expand our development pipeline into other high value disease targets and cancer," concluded Dr. Stephan.

First Fiscal Quarter of 2020 and Recent Operating Highlights

·U.S. Patent and Trademark Office issued NeuBase a foundational patent covering proprietary DNA and RNA binding technology, which enables PATrOL-based therapies to target the secondary structures of DNA and RNA
·Cancer biologist and RNA therapeutics pioneer, Steven Dowdy, Ph.D., appointed to the NeuBase Scientific Advisory Board

Financial Results for the Fiscal Quarter Ended December 31, 2019:

·For the three month period ended December 31, 2019, the Company reported a net loss of approximately $4.5 million, or a net loss of $0.26 per share, compared with a net loss of approximately $1.5 million, or a net loss of $0.25 per share, for the same period last year.
·For the three month period ended December 31, 2019, total operating expenses were approximately $3.8 million, consisting of approximately $2.6 million in general and administrative expenses and $1.2 million of research and development expenses. This compares with total operating expenses of $1.5 million for the same period last year, which was comprised of approximately $0.4 million in general and administrative expenses and $1.1 million in research and development and research and development-licenses acquired expenses.
·At December 31, 2019, the Company had cash and cash equivalents of approximately $7.7 million, compared with cash and cash equivalents of approximately $10.3 million at September 30, 2019. The Company believes that its current cash balance will provide sufficient capital to fund operations through the end of fiscal year 2020.

On March 26, 2020 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the fourth quarter and year ended December 31, 2019 (Press release, Celldex Therapeutics, MAR 26, 2020, View Source [SID1234555867]).

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"We are pleased that Celldex entered 2020 with significant momentum, following exciting data in late 2019 from the CDX-1140 program that suggest this candidate is a best in class CD40 agonist," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We are actively recruiting patients across multiple expansion cohorts to further explore potential indications and new combination approaches. We also continue to advance the Phase 2 program of our ErbB3 inhibitor, CDX-3379, exploring a potential biomarker strategy in head and neck squamous cell carcinoma."

"Last month, we completed dosing in the Phase 1 healthy volunteer study of our KIT inhibitor, CDX-0159, which we intend to study in mast cell driven disorders. In addition to demonstrating a favorable safety profile, if CDX-0159 is able to decrease tryptase levels in healthy volunteers, a surrogate for systemic mast cell load, we believe this drug candidate could have significant potential in mast cell driven diseases. Based on the promising results observed to date, we have expanded development of CDX-0159 and are planning to initiate studies in chronic urticaria. We are also preparing to advance CDX-527, the first candidate from our bispecific platform, into the clinic."

"In closing, our mission at Celldex is focused on combatting devastating diseases. With the COVID-19 pandemic unfolding around the world, we have embraced the importance of public health guidelines while implementing operational plans aimed at minimizing disruptions to our core programs and protecting the health of our staff and the communities around us. We have observed that many medical and scientific conferences have canceled, delayed or made modifications to their format. We are following this closely and we may elect to report data outside of these settings if necessary. As always, we look forward to reporting on our progress, including updates across our clinical programs over the course of the year."

Recent Pipeline Highlights:

CDX-1140—a potent CD40 agonist that Celldex believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile.

In the Phase 1 dose-escalation study of CDX-1140 in patients with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas both the monotherapy and combination with CDX-301 dose escalation portions of the trial are complete with an identified maximum tolerated dose (MTD) and recommended Phase 2 dose of CDX-1140 at 1.5 mg/kg—one of the highest systemic dose levels in the CD40 agonist class. Expansion cohorts are actively recruiting including:

— CDX-1140 with KEYTRUDA (pembrolizumab) in patients who have progressed on checkpoint therapy; and,

— CDX-1140 with CDX-301 in patients with head and neck squamous cell carcinoma (HNSCC).

In addition, a combination of CDX-1140 with chemotherapy in first line metastatic pancreatic cancer is planned.

Interim data from the dose escalation portion of the Phase 1 study were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting in November 2019. CDX-1140 achieved one of the highest systemic dose levels (1.5 mg/kg) in the CD40 agonist class. Clinical activity in both the monotherapy arm and the combination arm with CDX-301 was observed, including tumor necrosis in two patients with head and neck cancer, a RECIST partial response in gastroesophageal cancer and stable disease. CDX-1140 was associated with manageable immune-related adverse events.
CDX-3379—a differentiated human monoclonal antibody designed to block the activity of ErbB3 (HER3). ErbB3 is expressed in many cancers, including HNSCC and is believed to be an important receptor regulating cancer cell growth and survival as well as resistance to targeted therapies.

Enrollment continues in the Phase 2 study of CDX-3379 in advanced HNSCC in combination with Erbitux (cetuximab) in Erbitux-resistant patients who have been previously treated with or are ineligible for checkpoint therapy.

Data presented at the 2019 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2019 suggested that observed antitumor activity with CDX-3379 might be associated with somatic mutations in the FAT1 and NOTCH1, NOTCH2 or NOTCH3 (NOTCH1-3) genes—genes associated with tumor suppression. Based on these biomarker observations and the clinical activity observed in the ongoing Phase 2 study, the study was expanded (n= ~45 patients, including at least 15 patients with FAT1 mutations) to allow for an evaluation of the utility of biomarkers for patient selection.
CDX-0159—a monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells. In certain inflammatory diseases, such as chronic urticarias, mast cell degranulation plays a central role in the onset and progression of the disease.

Dosing was recently completed in the ongoing Phase 1 single ascending dose escalation study of CDX-0159 in healthy subjects. This study is designed to evaluate the safety profile, pharmacokinetics and pharmacodynamics of CDX-0159 and to select a dose for further study in mast cell driven diseases. The Phase 1 study also evaluates plasma tryptase levels in healthy subjects. Tryptase is an enzyme synthesized and secreted by mast cells and decreases in plasma tryptase levels reflect a systemic reduction in mast cell burden, even in healthy volunteers. If CDX-0159 is able to decrease systemic mast cell load in healthy volunteers, Celldex believes the drug candidate could have significant potential in mast cell driven diseases. Based on promising results observed to date, Celldex has expanded development of CDX-0159.

— The Company intends to further study CDX-0159 in chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CINDU), both mast cell-related diseases, and plans to initiate studies by year end. CSU presents as itchy hives, angioedema or both for at least six weeks without a specific trigger; multiple episodes can play out over years or even decades. About 50% of patients with CSU achieve symptomatic control with antihistamines or leukotriene receptor antagonists. Omalizumab, an IgE inhibitor, provides relief for roughly half of the remaining antihistamine/leukotriene refractory patients. Consequently, there is a need for more effective later line therapies. CINDUs are forms of urticaria that have an attributable cause or trigger associated with them, typically resulting in hives or wheals. Celldex is exploring cold-induced and dermographism-induced (scratching the skin) urticarias.

— A review of the CDX-0159 early development program was presented at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting in November 2019 in the Distinguished Industry Oral Abstract Session.
Celldex continues to advance a robust preclinical portfolio and data from the Company’s CDX-527 bispecific candidate were presented in November at SITC (Free SITC Whitepaper) 2019. CDX-527 uses Celldex’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway. The data presented at SITC (Free SITC Whitepaper) demonstrate that CDX-527 is more potent at T cell activation and anti-tumor immunity than the combination of parental monoclonal antibodies. Celldex plans to initiate a Phase 1 study in the second half of 2020.

Fourth Quarter and Twelve Months 2019 Financial Highlights and 2020 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2019 were $64.4 million compared to $72.9 million as of September 30, 2019. The decrease was primarily driven by fourth quarter cash used in operating activities of $11.0 million, partially offset by $2.4 million in net proceeds from sales of common stock under the Cantor agreement. At December 31, 2019, Celldex had 17.0 million shares outstanding.

Revenues: Total revenue was $0.9 million in the fourth quarter of 2019 and $3.6 million for the year ended December 31, 2019, compared to $1.8 million and $9.5 million for the comparable periods in 2018. The decrease in revenue was primarily due to lower revenue from the collaboration agreement with Bristol-Myers Squibb Company and the contract manufacturing and research and development agreements with the International AIDS Vaccine Initiative and Rockefeller University.

R&D Expenses: Research and development (R&D) expenses were $10.3 million in the fourth quarter of 2019 and $42.7 million for the year ended December 31, 2019, compared to $11.2 million and $66.4 million for the comparable periods in 2018. The decrease in R&D expenses was primarily due to lower clinical trial, personnel and contract manufacturing costs.

G&A Expenses: General and administrative (G&A) expenses were $3.2 million in the fourth quarter of 2019 and $15.4 million for the year ended December 31, 2019, compared to $4.3 million and $19.3 million for the comparable periods in 2018. The decrease in G&A expenses was primarily due to lower personnel and commercial planning costs and lower lease restructuring expense.

Intangible Asset and Goodwill Impairments: During the first quarter of 2018, the Company recorded $18.7 million in non-cash impairment charges related to fully impaired glembatumumab vedotin-related intangible assets and $91.0 million in goodwill impairment charges as the carrying value of the Company’s net assets exceeded the Company’s fair value by an amount in excess of the goodwill asset.

Changes in Fair Value Remeasurement of Contingent Consideration: During the year ended December 31, 2019, the Company recorded a $1.3 million gain on the fair value remeasurement of contingent consideration primarily due to changes in discount rates, the passage of time and updated assumptions for the varlilumab program.

Net Loss: Net loss was $10.4 million, or ($0.64) per share, for the fourth quarter of 2019 and $50.9 million, or ($3.51) per share, for the year ended December 31, 2019, compared to a net loss of $9.4 million, or ($0.81) per share, and $151.2 million, or ($14.48) per share, for the comparable periods in 2018.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2019 are sufficient to meet estimated working capital requirements and fund planned operations into the first quarter of 2021. This guidance excludes anticipated proceeds from future sales of common stock under the Cantor agreement or other potential fundraising.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA. Erbitux is a registered trademark of Eli Lilly & Co.

On March 26, 2020 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, reported financial results for the fourth quarter and year ended December 31, 2019 (Press release, Apollo Endosurgery, MAR 26, 2020, View Source [SID1234555866]). The Company will hold a conference call today at 3:30 p.m. CT / 4:30 p.m. ET to discuss its results.

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Highlights
•Fourth quarter U.S. OverStitch Endoscopic Suturing System ("ESS") sales increased 33% to $4.4 million
•Fourth quarter U.S. Endoscopy sales increased 31% to $5.6 million
•Worldwide ESS sales for the full year 2019 increased 21% (23% in constant currency) to $28.3 million, representing 63% of our Endoscopy sales
•Fourth quarter Orbera Intragastric Balloon System ("IGB") sales increased 23% in the U.S. and 11% (13% in constant currency) worldwide
Todd Newton, CEO of Apollo, said, "The Endoscopic Suturing market developed rapidly in 2019 as evidenced by Apollo’s 36% revenue growth for ESS products in the U.S. and 21% growth worldwide. Clinical publications providing evidence of the many applications for our ESS technology continued to expand during 2019, and Apollo’s new single channel OverStitch device introduced in November 2018 is taking our technology to a broader group of physicians and locations. Our strategy in the near term is to withstand the unprecedented challenges presented by the COVID-19 pandemic, and then return our focus as swiftly as possible to increasing the user base of our technology and to improve our operating efficiency as we continue to scale the business."
Due to unprecedented global economic conditions and uncertainty resulting from the COVID-19 pandemic, the Company will not be providing an outlook for 2020 at this time. We are closely monitoring the global impact to the health systems where we conduct business and the slowdown in business activity related to COVID-19, and hope to provide better clarity about our outlook for 2020 on our first quarter results call. In response to the rapidly changing conditions resulting from the COVID-19 pandemic, we have taken steps to limit business activities, to limit spending and maintain only key business functions in order to continue to fulfill product orders and support our customers while also taking proactive measures to protect the health and safety of our employees and their families consistent with local guidelines.
U.S. ESS product sales increased 33% to $4.4 million in the fourth quarter of 2019 and 36% to $14.9 million in the full year of 2019. Outside the U.S. ("OUS") ESS product sales decreased 15% (13% in constant currency) to $3.0 million for the fourth quarter of 2019 due primarily to the timing of distributor orders, while increasing 8% (13% in constant currency) to $13.4 million in the full year of 2019. Worldwide, ESS product sales increased 8% (9% in constant currency) and 21% (23% in constant currency) for the fourth quarter and full year of 2019, respectively.
U.S. IGB sales increased 23% to $1.2 million for the fourth quarter of 2019 and decreased 4% to $5.2 million for the full year of 2019. OUS IGB product sales increased 7% (9% in constant currency) to $3.1 million and decreased 5% (2% in constant currency) to $11.7 million for the fourth quarter and full year of 2019, respectively. Our efforts to expand IGB therapy in the U.S. market and advance twelve-month therapy OUS improved in the fourth quarter leading to reported growth in both regions and lifting our full year results close to break even with the prior year. Worldwide, IGB sales increased 11% (13% in constant currency) and decreased 5% (3% in constant currency) for the fourth quarter and full year of 2019, respectively.
Worldwide Endoscopy product sales increased 9% (10% in constant currency) and 10% (12% in constant currency) for the fourth quarter and full year of 2019, respectively. ESS product sales represented 64% and 63% of total Endoscopy sales for the fourth quarter and full year of 2019, respectively. In the U.S., Endoscopy sales increased 31% to $5.6 million and 22% to $20.1 million for the fourth quarter and full year of 2019, respectively.
The divestiture of our Surgical products in December of 2018 reduced total revenues by $4.1 million and $13.7 million for the fourth quarter and full year of 2019, respectively. We divested the Surgical products line in order to strengthen Apollo’s focus on our Endoscopy products, which we believe have high growth potential.
Gross margin for the fourth quarter of 2019 was 49%, compared to 47% for the fourth quarter of 2018. Gross margin for the full year of 2019 decreased to 51% compared to 55% for the full year of 2018 as a result of a greater proportion of our overall product sales coming from our ESS products, which realize a lower gross margin than our other products. Management has previously discussed its ongoing gross margin improvement initiative.

Total operating expenses decreased $11.2 million to $12.7 million for the fourth quarter of 2019 and decreased $24.1 million to $49.2 million for the full year of 2019 compared to the same periods of 2018. Excluding the one-time $7.8 million loss on divestiture of our Surgical products in December of 2018, the subsequent reduction in intangible asset amortization expense of $1.2 million and $5.0 million for the fourth quarter and full year of 2019, respectively resulting from this divestiture and a one-time $5.6 million settlement gain reported in the first quarter of 2019, total operating expenses decreased $2.3 million and $5.7 million for the fourth quarter and full year of 2019, respectively. This reduction in recurring operating expenses was the result of lower U.S. direct to consumer advertising and lower clinical trial costs as enrollment or other milestones were reached on the clinical studies that the Company is funding.
Net loss for the fourth quarter of 2019 was $7.2 million compared to $18.4 million for the fourth quarter 2018. For the full year, net loss was $27.4 million in 2019 compared to $45.8 million in 2018.
Cash, cash equivalents and restricted cash were $30.9 million as of December 31, 2019.
Conference Call
Apollo will host a conference call on March 26, 2020 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, 2019.
To participate in the conference call dial 844-369-8770 for domestic callers and +1-862-298-0840 for international callers. A live webcast of the conference call will be made available on the "Events and Presentations" section of our Investor Relations website: ir.apolloendo.com.
A replay of the webcast will remain available on Apollo’s website, www.apolloendo.com, following the call.
Non-GAAP Financial Measures
To supplement our financial results, we are providing a non-GAAP financial measure, percentage revenue change in constant currency, which removes the impact of changes in foreign currency exchange rates that affect the comparability and trend of revenues compared to the same period of the prior year. Percentage revenue change in constant currency is calculated by translating current foreign currency sales at last year’s exchange rate. This supplemental measure of our performance is not required by, and is not determined in accordance with GAAP.
We believe the non-GAAP financial measure included herein is helpful in understanding our current financial performance. We use this supplemental non-GAAP financial measure internally to understand, manage and evaluate our business, and make operating decisions. We believe 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. However, our non-GAAP financial measure is not meant to be considered in isolation or as a substitute for the comparable GAAP metric.