On November 2, 2016 Genmad reported its interim Report for First Nine Months Ended September 30, 2016 (Press release, Genmab, NOV 2, 2016, View Source [SID1234516222]).
Highlights
Net Sales of DARZALEX (daratumumab) by Janssen for the first nine months of 2016 were USD 372 million, resulting in royalty income of USD 45 million (DKK 298 million)
Announced U.S. and European regulatory submissions for daratumumab in relapsed or refractory multiple myeloma, triggering USD 25 million in milestone payments
Daratumumab received second Breakthrough Therapy Designation from U.S. Food and Drug Administration (FDA)
Announced FDA approval of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide for relapsed chronic lymphocytic leukemia (CLL)
Entered commercial license agreement with Gilead Sciences for DuoBody Technology
2016 financial guidance improved
"Throughout the third quarter we continued to see excellent progress in our DARZALEX program with Janssen. Regulatory applications to expand the label for daratumumab to include relapsed or refractory multiple myeloma were submitted in the U.S. and Europe, triggering USD 25 million in milestone payments. Daratumumab also received its second Breakthrough Therapy Designation from the FDA. We continued to see progress with Arzerra too, with another CLL indication approved in the U.S., and we made progress with our DuoBody technology, with a new commercial agreement with Gilead Sciences," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Nine Months of 2016
Revenue was DKK 889 million in the first nine months of 2016 compared to DKK 558 million in the first nine months of 2015. The increase of DKK 331 million, or 59%, was mainly driven by higher royalty and milestone revenue under our daratumumab collaboration with Janssen.
Operating expenses were DKK 544 million in the first nine months of 2016 compared to DKK 380 million in the first nine months of 2015. The increase of DKK 164 million, or 43%, was due to the additional investment in our pipeline of products, including the advancement of tisotumab vedotin, HuMax-AXL-ADC, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and our other pre-clinical programs.
Operating income was DKK 345 million in the first nine months of 2016 compared to DKK 355 million in the first nine months of 2015. The decrease of DKK 10 million, or 3%, was driven by the one-time reversal of the ofatumumab funding liability of DKK 176 million in 2015, combined with increased operating expenses in 2016, which were partly offset by higher revenue in 2016.
On September 30, 2016, Genmab had a cash position of DKK 3,942 million compared to DKK 3,493 million at December 31, 2015. This represented a net increase of DKK 449 million, which was driven primarily by income from operations and the proceeds from the exercise of warrants of DKK 184 million, partially offset by the purchase of treasury shares for DKK 118 million.
Business Progress Third Quarter
Daratumumab
August: Regulatory submission in Europe for daratumumab (DARZALEX) in patients with multiple myeloma who have received at least one prior therapy. In addition, a regulatory application was submitted in the U.S. for the use of daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who received at least one prior therapy. The submissions triggered milestone payments of USD 10 million, and USD 15 million, respectively, to Genmab.
July: The FDA granted Breakthrough Therapy Designation for DARZALEX injection in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Ofatumumab
August: The FDA approved ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed CLL.
DuoBody
August: Entered an agreement to grant Gilead Sciences, Inc. an exclusive license and an option on a second exclusive license, to use the DuoBody technology platform to create and develop bispecific antibody candidates for a therapeutic program targeting HIV. Under the terms of the agreement, Genmab received an upfront payment of USD 5 million from Gilead Sciences.
Subsequent Event
October: The FDA granted Priority Review for the use of daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of February 17, 2017 to take a decision on daratumumab in this indication. In addition, the FDA granted a Standard Review period for the use of daratumumab in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including a proteasome inhibitor (PI) and an immunomodulatory agent. The PDUFA date for the combination of daratumumab with pomalidomide/dexamethasone is June 17, 2017.
Outlook
Genmab is improving its 2016 financial guidance published on August 9, 2016 due to increased royalty and milestone income related to the sales of DARZALEX resulting in increased operating income and cash position.
MDKK Revised Guidance Previous Guidance
Revenue 1,200 — 1,250 975 — 1,025
Operating expenses (800) — (850) (800) — (850)
Operating income 375 — 425 150 — 200
Cash position at end of year* 3,650 — 3,750 3,550 — 3,650
*Cash, cash equivalents, and marketable securities

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On November 2, 2016 Provectus Biopharmaceuticals, Inc. (OTCQB:PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), reported that researchers will present data on the treatment of pancreatic cancer with PV-10, an investigational ablative immunotherapy under development by Provectus for solid tumor cancers, at the 31st Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Provectus Pharmaceuticals, NOV 2, 2016, View Source [SID1234516169]).

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The poster, "Intralesional injection with rose bengal and systemic chemotherapy induces anti-tumor immunity in a murine model of pancreatic cancer," will detail research undertaken at Moffitt Cancer Center by a team of scientists led by Shari Pilon-Thomas.

Dr. Pilon-Thomas has informed Provectus that she will be present Saturday, November 12 at both the SITC (Free SITC Whitepaper) luncheon from 11:45 a.m. to 1:00 p.m. as well as the Poster Reception from 6:45 to 8:00 p.m.

The poster presentation is number 264. The full abstract will be available on line at SITC (Free SITC Whitepaper)ancer.org on November 8 according to conference organizers.

The 31st SITC (Free SITC Whitepaper) Annual Meeting and Associated Programs will be held November 9-13 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.

On November 2, 2016 Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) reported its financial results for the third quarter ended September 30, 2016 (Press release, Momenta Pharmaceuticals, NOV 2, 2016, View Source [SID1234516200]).

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For the third quarter of 2016, the Company reported total revenues of $29.1 million, including $23.3 million in product revenues from Sandoz’s sale of Glatopa (glatiramer acetate injection). For the nine months ended September 30, 2016, the Company reported total revenues of $75.4 million, including $58.8 million of product revenues from Sandoz’s sales of Glatopa. Momenta reported a net loss of $(17.5) million, or $(0.26) per share for the third quarter of 2016 compared to a net loss of $(30.1) million, or $(0.44) per share for the same period in 2015. For the nine months ended September 30, 2016, the Company reported a net loss of $(62.5) million, or $(0.91) per share compared to a net loss of $(54.1) million, or $(0.88) per share for the same period in 2015. At September 30, 2016, the Company had cash, cash equivalents, and marketable securities of $309.0 million compared to $336.9 million at June 30, 2016.

"Our biosimilars collaboration with Mylan continues to advance. Today we announced the initiation of a Phase 1 trial for our lead candidate, M834, a biosimilar version of ORENCIA. We also recently re-gained the rights to M923, our biosimilar HUMIRA candidate, and believe this is a real opportunity for us to generate additional value from this product," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "Glatopa 20 mg sales continued to provide us with a healthy revenue stream, and we remain optimistic for the potential launch of our Glatopa 40 mg product candidate early next year."

Third Quarter Highlights and Recent Events

Complex Generics:

In the third quarter of 2016, Momenta recorded $23.3 million in product revenues from Sandoz’s Glatopa sales.
The Abbreviated New Drug Application (ANDA) submitted by Sandoz for a three-times-a-week generic COPAXONE 40 mg (glatiramer acetate injection) is under U.S. Food and Drug Administration (FDA) review. The Company expects to receive tentative regulatory approval in the next few months.
A district court trial challenging four of Teva’s five Orange Book-listed patents for COPAXONE 40 mg (glatiramer acetate injection) concluded on October 6, 2016. The Company expects a decision to be issued in the first quarter of 2017.
Biosimilars:

Momenta and its collaboration partner Mylan reported the initiation of a Phase 1 clinical trial for M834, a biosimilar ORENCIA (abatacept) candidate. Under the Mylan collaboration agreement, Momenta achieved a regulatory milestone thereby earning a $25.0 million payment from Mylan. The companies plan to report top-line data from the trial by the end of 2017.
In September, the U.S. Patent and Trademark Office held a hearing in Inter Partes Review (IPR) proceedings for the Company’s challenge of the validity of Bristol Myers Squibb’s U.S. Patent No. 8,476,239 covering formulations of ORENCIA which is set to expire in 2028. The Patent Office’s decision is due by January 15, 2017.
In September, Momenta regained global development and commercialization rights to M923, a biosimilar HUMIRA (adalimumab) candidate. Shire exercised its right to terminate the collaboration agreement for M923 following its combination with Baxalta. Under the terms of the collaboration, the agreement will terminate twelve months following the notice, and Shire is obligated to fund the M923 program until termination. The Company plans to release top-line results from the Phase 3 clinical trial for M923 in late 2016, and the first regulatory submission for marketing approval is planned for mid-2017. Subject to marketing approval and patent considerations, the Company expects first commercial launch of M923 to be as early as 2018.
Novel Drugs for Autoimmune Indications:

Momenta’s novel autoimmune portfolio includes two recombinant molecules: M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. The Company has initiated a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of M281 in healthy subjects and expects to report data in the second half of 2017. M230 is in pre-clinical development, and the Company expects to initiate a clinical trial for M230 in 2017. Momenta is also developing a hyper-sialylated IVIg (M254) as a potential high potency version of IVIg. The Company continues its efforts to identify potential collaboration opportunities for the further development and commercialization of its novel drug candidates for autoimmune indications.

Corporate:

The Company announced today the appointment of Scott M. Storer as Senior Vice President and Chief Financial Officer effective November 28, 2016. Mr. Storer will replace Momenta’s current Chief Financial Officer, Rick Shea, who will be retiring. Mr. Storer will report directly to Craig Wheeler, Momenta’s President and Chief Executive Officer, and will serve as a member of the Executive Committee. Prior to joining Momenta, Mr. Storer was Senior Vice President, Finance at Baxalta, Inc. following its spin-out from Baxter International in July 2015. He joined Baxter in 1997 and previously held several positions, most recently serving as Vice President of BioScience Finance.

Third Quarter 2016 Financial Results

Total revenues for the third quarter of 2016 were $29.1 million compared to $13.8 million for the same period in 2015. Total revenues for the third quarter of 2016 include $23.3 million in product revenue earned from net sales of Glatopa by Sandoz, compared to $8.7 million in product revenue earned from net sales of Glatopa by Sandoz for the same period in 2015. The increase in product revenue was due to a higher number of Glatopa units sold in the 2016 period.

Collaborative research and development revenue for the third quarter of 2016 was $5.8 million compared to the $5.1 million recorded in the same quarter last year. The increase of $0.7 million, or 14%, from the 2015 period to the 2016 period was primarily due to $1.8 million of revenue recognized in the third quarter of 2016 from the amortization of the $45 million upfront payment under the Mylan collaboration agreement, offset by lower reimbursable expenses for M923. Collaborative reimbursement revenues from Sandoz and Baxalta, now part of Shire, were $1.5 million for the third quarter of 2016, compared to $2.7 million for the same period in 2015.

Research and development expenses for the third quarter of 2016 were $31.6 million, compared to $31.7 million for the same period in 2015. The decrease of $0.1 million from the 2015 period to the 2016 period was due to a decrease of $7.7 million for Mylan’s 50% share of biosimilar collaboration costs, offset primarily by increases of $3.2 million in process development costs for biosimilars under the Company’s collaboration with Mylan, $1.9 million in non-clinical expenses to advance the Company’s novel autoimmune programs and $1.8 million in necuparanib Phase 2 clinical trial costs due in part to the termination of the development program.

General and administrative expenses for the quarter ended September 30, 2016 were $15.8 million, compared with $12.5 million for the same period in 2015. The increase of $3.3 million, or 26%, was primarily due to increases of $1.4 million in personnel-related expenses due to growth in headcount, $1.5 million in legal and professional fees, $0.4 million in stock-based compensation primarily due to performance-based restricted stock awards granted in 2016 and $0.4 million in facilities expenses. These increases were offset by a decrease of $0.4 million for Mylan’s 50% share of biosimilar collaboration costs.

At September 30, 2016, Momenta had $309.0 million in cash, cash equivalents and marketable securities.

Financial Guidance

Momenta provides non-GAAP operating expense guidance, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the section of this press release below entitled "Non-GAAP Financial Information and Other Disclosures" for further discussion of this subject.

Today, Momenta reiterated its non-GAAP operating expense guidance of approximately $40 – $45 million for the fourth quarter of 2016. Non-GAAP operating expense is total operating expenses (which is net of Mylan’s share of collaboration expenses), excluding stock-based compensation expense and net of collaborative reimbursement revenues from Sandoz and Baxalta, now part of Shire. The quarterly recognition of collaborative revenues under the Company’s collaboration with Mylan is expected to be $1.8 million per quarter. Under the collaboration with Baxalta, the Company expects to recognize collaborative revenues of approximately $3.7 million per quarter for the next three quarters and approximately $3.5 million in the third quarter of 2017 representing the remaining balance of deferred revenue.

On November 2, 2016 Immunomedics, Inc. (Nasdaq:IMMU) reported financial results for the first quarter ended September 30, 2016. The Company also highlighted recent key developments and planned activities for its clinical pipeline (Filing, Q3, Immunomedics, 2016, NOV 2, 2016, View Source [SID1234516285]).

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First Quarter Fiscal 2017 Results

Total revenues for the first quarter ended September 30, 2016, were $0.7 million, the same amount reported for the quarter ended September 30, 2015.

Total costs and expenses for the quarter ended September 30, 2016 were $15.7 million, compared to $14.8 million for the same quarter in fiscal 2016, an increase of $0.9 million, or approximately 6%. The increase was due primarily to a $4.9 million increase in research and development expenses related to manufacturing and Phase 2 clinical trials of the antibody-drug conjugates, including sacituzumab govitecan (IMMU-132), which was offset partially by a $3.0 million decrease in research and development expense from the early termination of the Phase 3 PANCRIT-1 clinical trial during the third quarter of fiscal 2016, and a $1.1 million decrease from adjustments for deferred unearned executive bonuses.

Interest expense related to the 4.75% Convertible Senior Notes due 2020 was $1.4 million for both quarters ended September 30, 2016 and September 30, 2015, including amortization of $0.2 million debt issuance costs in each quarter.

Net loss attributable to stockholders was $16.2 million, or $0.17 per basic and diluted share, for the first quarter of fiscal year 2017, compared with net loss attributable to stockholders of $15.4 million, or $0.16 per basic and diluted share, for the same quarter in fiscal 2016, an increase of $0.8 million, or approximately 5%. The increase was due primarily to increased research and development expenses, as described above.

Cash, cash equivalents, and marketable securities were $33.0 million as of September 30, 2016. On October 12, 2016, the Company sold 10 million shares of its common stock and warrants to purchase up to 10 million shares of common stock for net proceeds of approximately $28.5 million.

"The recent offering of stock and warrants has strengthened our balance sheet, which we believe should facilitate uninterrupted clinical and manufacturing activities for IMMU-132, while simultaneously continuing our out-licensing efforts," commented Michael R. Garone, Vice President Finance and Chief Financial Officer. "We are committed to pursuing these strategic goals to completion for the benefit of cancer patients; particularly those with metastatic triple-negative breast cancer, for whom there are no targeted therapies currently available." Mr. Garone added.

The Company’s key clinical developments and future planned activities:

Sacituzumab Govitecan (IMMU-132)

Updated Phase 2 clinical trial results of IMMU-132 in patients with metastatic triple-negative breast (TNBC) have been submitted for publication

Manufacturing of clinical materials for the Phase 3 confirmatory trial in TNBC is progressing according to plan. Large-scale batches have been produced by our Contract Manufacturing Organizations, and are moving through quality control and comparability testing requirements

Patient enrollment in the Phase 2 clinical trial in TNBC is nearing completion with the 100 assessable patients for planned accelerated approval application

On November 2, 2016 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported a corporate update and reported financial results for the third quarter ending September 30, 2016 (Press release, PTC Therapeutics, NOV 2, 2016, View Source [SID1234516313]).

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"For the past 18 years, we have focused significant effort towards developing Translarna for those affected by Duchenne," stated Stuart W. Peltz, Ph.D. Chief Executive Officer, PTC Therapeutics, Inc. "Over 400 Duchenne patients have participated in our clinical trials dating back to 2005 and the vast majority continue to remain on Translarna including approximately 130 boys in the United States. With this high compliance rate, we believe these actions speak to the benefit Translarna is providing to patients in the U.S. and around the world. In the E.U., regulatory discussions continue and we anticipate an opinion from the CHMP before the end of the year. With respect to the U.S., we will continue to escalate our appeal so that we may have the opportunity to have the Translarna NDA submission reviewed by the FDA. Our goal remains to deliver this novel therapy to nonsense mutation Duchenne patients globally."

Key Third Quarter and Other Corporate Highlights:

Translarna net sales of $22M in the third quarter represents 125% year-over-year growth. Commercial access to Translarna continued to expand during the quarter with a significant number of new patients coming from England. While pricing and reimbursement discussions with a number of European countries are ongoing, PTC has now successfully concluded pricing and reimbursement negotiations in both Italy and Romania. PTC anticipates growth from both additional penetration into existing markets as well as expanding access in new geographies across Central and Eastern Europe, the Middle East and Latin America.
EMA regulatory discussions regarding Translarna’s marketing authorization are ongoing. PTC continues to interact with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in connection with the company’s ongoing request for annual renewal of its marketing authorization for Translarna. Following the company’s CHMP meeting in October, the committee requested additional information regarding the risk-benefit profile of Translarna, its efficacy and the design of a potential trial that would provide comprehensive clinical data. While we have provided information in response to the CHMP’s requests and expect to continue to engage in further interactions, recent dialogue has introduced a higher degree of uncertainty as to the outcome. PTC anticipates that an opinion regarding its marketing authorization renewal request will be adopted by the CHMP before the end of 2016. The current marketing authorization remains valid while the EMA assessment is ongoing and until a decision is made by the European Commission.
Appeal process of FDA’s Refuse to File regarding Translarna for DMD continues. As PTC previously stated, the RTF appeal could be an iterative process requiring multiple rounds before a conclusion. Having had its appeal denied, the company intends to continue the appeal to higher levels of the FDA. PTC continues to believe that the FDA can only accomplish a proper assessment of the data and analyses based on the results of the company’s extensive clinical research and experience in more than 400 boys in the context of a full and fair review. This would include an advisory committee meeting that allows DMD clinical experts and representatives of the patient community to express their views on Translarna for the treatment of nmDMD. PTC intends to provide an update following a final conclusion of the appeal process or, alternatively, following a determination by the company to pursue an alternate regulatory strategy for advancing the potential approval of Translarna for the treatment of nmDMD in the U.S.
ACT CF Phase 3 clinical trial results expected late first quarter 2017. PTC’s confirmatory Phase 3 ACT CF clinical trial, a 48-week placebo-controlled trial designed to evaluate the efficacy of Translarna in patients six years of age or older with nonsense mutation cystic fibrosis, is ongoing. Following feedback from the FDA and the company’s CHMP rapporteurs during the third quarter, PTC modified the protocol for ACT CF. In-line with clinical trials for other approved CF therapies, the primary endpoint of lung function as measured by FEV1 was updated from relative change to absolute change in percent predicted FEV1. Pulmonary exacerbations will be an important secondary endpoint.
SMA program advancing with Phase 2 SUNFISH trial initiated in Type 2/3 patients. PTC’s joint development program in Spinal Muscular Atrophy (SMA) with Roche and the SMA Foundation initiated a Phase 2 study in pediatric and adult Type 2/3 SMA patients. SUNFISH, is a two-part study investigating the safety, tolerability and efficacy of RG7916, an oral small molecule survival motor neuron 2 (SMN2) splicing modifier. The first part of the study will evaluate safety and tolerability through escalating doses of RG7916. After dose selection, the study will transition into the pivotal second part evaluating the efficacy of RG7916. Initiation of the pivotal second part of the study is expected to begin in 2017 and will trigger a $20 million milestone payment to PTC from Roche. A similarly designed two-part study to evaluate RG7916 in Type 1 SMA patients is expected to begin in the coming months.
PTC596 cancer stem cell program to advance in clinical development in 2017.
Phase 1 safety data from PTC’s clinical oncology program were recently presented at the European Society for Medical Oncology Congress. The ongoing Phase 1 dose-escalation study is evaluating the safety, tolerability and pharmacokinetics of PTC596 in patients with advanced solid tumors as a monotherapy. Preliminary results demonstrate that PTC596 is generally well tolerated at doses associated with exposures that achieved or exceeded efficacious target plasma concentrations in preclinical studies. Escalating doses are being evaluated for safety, pharmacodynamics, and to determine a target dose for subsequent studies. PTC596 is a novel, oral investigational drug that reduces the levels of BMI1, a protein that is required for cancer stem cell survival. Based on its proposed mechanism of action, PTC596 is expected to be most efficacious when used as part of combination therapy. Continued clinical development of PTC596 is being planned for 2017.
Third Quarter Financial Highlights:

Translarna net product sales were $22.0 million for the third quarter of 2016, representing a 125% increase versus $9.8 million in the third quarter of 2015. Net sales increased in conjunction with continued expansion of commercial access to Translarna for nonsense mutation DMD boys outside of the U.S.
Total revenues for the third quarter of 2016 were $23.0 million, an increase of $13.2 million or 135% compared to $9.8 million in the same period of 2015. The change in total revenue was primarily a result of the expanded commercial launch of Translarna.
GAAP R&D expenses were relatively flat at $31.4 million for the third quarter of 2016 compared to $30.6 million for the same period in 2015. Non-GAAP R&D expenses were $27.1 million for the third quarter of 2016, excluding $4.3 million in non-cash, stock-based compensation expense, compared to $26.8 million for the same period in 2015, excluding $3.8 million in non-cash, stock-based compensation expense.
GAAP SG&A expenses were $23.7 million for the third quarter of 2016 compared to $21.4 million for the same period in 2015. Non-GAAP SG&A expenses were $19.0 million for the third quarter of 2016, excluding $4.6 million in non-cash, stock-based compensation expense, compared to $17.1 million for the same period in 2015, excluding $4.2 million in non-cash, stock-based compensation expense. The increase in SG&A expense for the third quarter 2016 as compared to the prior year period primarily resulted from additional costs associated with commercial activities in support of Translarna across Europe and other regions.
Net interest expense for the third quarter of 2016 was $2.1 million compared to net interest expense of $0.9 million in the same period in 2015. The increase in interest expense is primarily a result of the $150 million convertible debt offering completed during mid-third quarter 2015. The debt was recorded on PTC’s balance sheet at a discount, which will be amortized over the life of the bond.
Net loss for the third quarter of 2016 was $35.2 million, a decrease of $8.1 million compared to a net loss of $43.2 million for the same period in 2015.
Cash, cash equivalents, and marketable securities totaled approximately $248.3 million at September 30, 2016 compared to approximately $338.9 million at December 31, 2015.
Shares issued and outstanding as of September 30, 2016 were 34.3 million, which includes 0.2 million shares of unvested restricted stock.
2016 Guidance:

PTC expects to achieve total ex-US nmDMD Translarna net sales in the middle of our guidance of $65 to $85 million for 2016.
Operating expenses for the full year 2016 are now anticipated to be between $180 million and $190 million, excluding expected non-cash stock-based compensation expense of approximately $35 million, for total operating expenses of approximately $215 million to $225 million. These expenses are in support of our ongoing clinical trials for Translarna in nmDMD and nmCF, commercial launch activities for Translarna outside of the U.S., and the continued research and clinical development of other product pipeline candidates.
PTC expects to end 2016 with cash and cash equivalents of approximately $220 million.