On May 10, 2016 IntelGenx Corp. (TSX-V: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") reported its first quarter 2016 financial results for the three-month period ended March 31, 2016 (Filing, Q1, IntelGenx, 2016, MAY 10, 2016, View Source [SID:1234512491]). All amounts are in U.S. Dollars unless otherwise stated. The Company will host a conference call to provide a corporate update on Thursday, May 12th at 9:00 a.m. ET. Details of the conference call and webcast are listed below in this release.

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2016 First Quarter Financial Highlights:

• Revenues reached $818 thousand, an increase of 31% over the same period last year

• Net comprehensive loss was ($707 thousand), compared to a net comprehensive loss of ($377 thousand) over the same period last year

• Adjusted EBITDA loss was ($556 thousand), compared to adjusted EBITDA of $51 thousand over the same period last year

• Cash and cash equivalents totaled $2.1 million as at March 31, 2016
Recent Operational Highlights:

• Net sales of Forfivo XL in the first quarter of 2016 increased by 39% to $2.5 million ($4.9 million gross) compared to net sales of $1.8 million ($3.3 million gross) over the same period last year

• Submitted a patent application with the U.S. patent office for an oral film dosage form containing Loxapine for the treatment of anxiety and aggression in patients suffering from schizophrenia or bipolar 1 disorder

• Granted from the USPTO a patent protecting Rizaport, an oral thin film formulation of Rizatriptan benzoate for the treatment of acute migraines. This patent protects the composition of Rizaport and will be listed in the Orange Book upon approval of the product by the FDA

• Announced a development and commercialization term sheet with a global pharmaceutical company for up to three products. If entered into, IntelGenx expects the definitive agreement to be finalized in the second quarter of 2016

• Signed a commercialization term sheet for RizaportTM with Grupo Juste for Spain and additional potential territories. If entered into, IntelGenx expects the definitive agreement to be finalized in the second quarter of 2016

• Construction was successfully completed on the new state-of-the-art manufacturing and laboratory facilities which are expected to be fully operational by 2017. All of the new manufacturing equipment has been delivered and is being installed

"We made significant progress to start the year with the clear goal of transforming IntelGenx into a global leader of innovative pharmaceutical oral film development and manufacturing," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "Several key initiatives were successfully achieved with the completion of the construction of our state-of-the-art manufacturing facilities, the strengthening of our management team and the execution of two commercialization term sheets for a total of four products. The new team has been working hard together to build on each other’s strengths in laying out IntelGenx’ foundation for long-term growth. We very much look forward to communicating with shareholders on the future success of the organization."

Financial Results:

Total revenues for the three-month period ended March 31, 2016 amounted to $818 thousand, representing an increase of $193 thousand or 31% compared to $625 thousand for the three-month period ended March 31, 2015. The increase for the three-month period ended March 31, 2016 compared to last year’s corresponding period is mainly attributable to the attainment of milestones, totaling $3 million from which $2.67 million was recorded in the last fiscal year and $333 thousand in the first quarter of 2016.

Operating costs and expenses were $1.5 million for the three-month period ended March 31, 2016 compared to $610 thousand for the corresponding period of 2015. The increase for the three-month period ended March 31, 2016 is mainly attributable to an increase in Research and Development expenses of $364 thousand and Selling, General and Administrative of $498 thousand.

For the first quarter of 2016, the Company generated an operating loss of ($706 thousand) compared to an operating gain of $15 thousand for the comparable period of 2015.

Net comprehensive loss was ($707 thousand) or ($0.01) on a basic and diluted per share basis for the first quarter of 2016 compared to a net comprehensive loss of ($377 thousand) or ($0.00) on a basic and diluted per share basis for the comparable period of 2015.

Cash on hand as at March 31, 2016 was $2.1 million, representing a decrease of ($798 thousand) compared with the balance of $2.9 million as at December 31, 2015. The decrease in cash relates to the comprehensive loss incurred in the first quarter.

On May 10, 2016 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported company highlights and financial results for the first quarter ended March 31, 2016 (Press release, Ignyta, MAY 10, 2016, View Source [SID:1234512213]).

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"During 2016, we have continued to make significant progress towards becoming a leading precision medicine company focused on the development of first-in-class and best-in-class therapies for the benefit of cancer patients, and we have steadily advanced each of our three clinical stage assets," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "For our lead program, entrectinib, we have continued to successfully execute our potentially registration-enabling Phase 2 clinical trial, STARTRK-2. We also announced at the AACR (Free AACR Whitepaper) Annual Meeting compelling results from our two Phase 1 clinical trials, highlighting entrectinib’s emerging safety and efficacy profile. For the RXDX-105 program, we selected a recommended Phase 2 dose and initiated the Phase 1b portion of our ongoing clinical trial. For the taladegib program, we reported a complete response in a patient with medulloblastoma – providing the first clinical proof of concept for taladegib in a solid tumor type outside of advanced basal cell carcinoma. Finally, we strengthened our balance sheet, enabling us to continue to move rapidly to develop meaningful new therapies for the benefit of cancer patients."

Company Highlights

Updated Entrectinib Data Presented at AACR (Free AACR Whitepaper) Annual Meeting

In April 2016, updated results of the two Phase 1 clinical trials of entrectinib, the company’s proprietary oral tyrosine kinase inhibitor targeting solid tumors harboring activating alterations to NTRK1, NTRK2, NTRK3, ROS1, or ALK, were presented in an oral plenary session at the 2016 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in New Orleans, Louisiana.

The data cut-off for the AACR (Free AACR Whitepaper) presentation was March 7, 2016. Highlights of the data included:

Safety

A total of 119 patients with a range of solid tumors had been dosed across the two Phase 1 clinical trials, with 45 patients treated at the recommended Phase 2 dose (RP2D) of 600 mg, taken orally once per day (QD).

Entrectinib was well tolerated:

Across both studies, the most frequent (>10% incidence) treatment-related adverse events were fatigue (44%), dysgeusia (41%), paresthesia (28%), nausea (24%), and myalgia (22%).
The vast majority of treatment-related adverse events were Grade 1 or 2 in severity.
The most frequent (>2% incidence) Grade 3 treatment-related adverse events were fatigue (4%) and anemia (3%).
Adverse events were reversible with dose modification.
There was no evidence of cumulative toxicity, hepatic or renal toxicity, or QTc prolongation.
Efficacy

Across the two Phase 1 clinical studies, there were 25 patients treated who met the company’s Phase 2 clinical trial eligibility criteria, which include:

Presence of NTRK1/2/3, ROS1, or ALK gene rearrangements, as opposed to other types of molecular alterations (e.g., SNPs, amplifications, deletions);
Naïve to inhibitors of the relevant target (Trk, ROS1, or ALK, respectively); and
Treatment at or above the RP2D.
Among the 25 patients treated who met the company’s Phase 2 clinical trial eligibility criteria, tumor regression was seen in 80% (20 out of 25 treated patients):

Twenty-four patients had tumors that were evaluable by RECIST criteria. The overall response rate by RECIST was 79% (19 responses, including two complete responses, out of 24 treated patients, as assessed and confirmed by the clinical sites).
One patient had an astrocytoma. Assessment by RECIST criteria demonstrated stable disease. However, since RECIST criteria are not validated for primary brain tumors, the clinical site performed three-dimensional volumetric analysis of this patient’s tumor to determine changes in tumor size, which resulted in an estimated 45% decrease in tumor size from baseline.
The responses included:
with respect to patients with NTRK1/2/3 gene rearrangements who met the company’s Phase 2 eligibility criteria, three confirmed responses out of three patients evaluable by RECIST criteria, one of whom had metastases to the central nervous system that resulted in a complete response. In addition, a patient with an astrocytoma had a response as determined by volumetric analysis. Two of these Trk patients remained on study, one of whom had been on study for longer than 12 months;
with respect to patients with ROS1 gene rearrangements who met the company’s Phase 2 eligibility criteria, 12 confirmed responses out of 14 patients, including 11 confirmed responses out of 13 patients with non-small cell lung cancer (NSCLC). Eleven of the ROS1 responders remained on study in response, with the longest at 27 months. One ROS1 NSCLC patient has met the criteria for RECIST progression but has remained on study due to clinical benefit; and
with respect to patients with ALK gene rearrangements who met the company’s Phase 2 eligibility criteria, four confirmed responses out of seven patients, with another patient having stable disease. Two of the responders remained on study in response, as did the patient with stable disease.
Many of these responses occurred rapidly, within the first four weeks of entrectinib treatment. Seventeen of the patients remained on study treatment, having received up to 27 months of treatment. Of note, three of four patients with primary or metastatic central nervous system (CNS) disease responded.

In addition, the AACR (Free AACR Whitepaper) presentation included a late-breaking case study of a 20-month-old baby boy with NTRK3-rearranged infantile fibrosarcoma that had metastasized to the brain, who had exhausted all available therapies and was enrolled under a compassionate use protocol and therefore was not included in the Phase 1 cohort. The patient was first dosed in February 2016, and after five weeks of treatment experienced a decrease in his brain lesions of approximately 58%, as estimated from radiology assessment, with accompanying clinical improvement.

Expansion of RXDX-105 Clinical Trial

In March 2016, the company announced the selection of an RP2D and the initiation of the Phase 1b portion of its Phase 1/1b clinical trial of RXDX-105, the company’s orally available, small molecule multikinase inhibitor with potent activity against such targets as RET and BRAF. The Phase 1b portion of the study utilizes a basket design focusing on patients with solid tumors that contain molecular alterations of RET or BRAF. In addition, based on clinical data seen to date, the company intends to build into the Phase 1b portion of the study one or more baskets to evaluate RXDX-105 in both squamous non-small cell lung cancer and non-small cell lung adenocarcinoma.

Taladegib Complete Response Outside of Basal Cell Carcinoma

In April 2016 at the AACR (Free AACR Whitepaper) Annual Meeting, the company reported the first clinical proof of concept for taladegib in a solid tumor type outside of advanced basal cell carcinoma, in a patient with medulloblastoma who had a complete response. The company further announced that it would be exploring medulloblastoma and other solid tumor types driven by hedgehog pathway alterations in a Phase 1b basket study, which is expected to be initiated in the third quarter of 2016.

Financing Transaction

In May 2016, the company issued an aggregate of 9.2 million shares of its common stock in an underwritten public offering at a purchase price of $6.25 per share, which resulted in aggregate gross proceeds of $57.5 million.

First Quarter 2016 Financial Results

For the first quarter of 2016, net loss was $25.5 million, or $0.79 per share, compared with $23.5 million, or $1.15 per share, for the first quarter of 2015.

Ignyta did not record any revenue for the three months ended March 31, 2016, or for the three months ended March 31, 2015.

Research and development expenses for the first quarter of 2016 were $19.8 million, compared with $20.2 million for the first quarter of 2015. During the first quarter of 2015, the company recorded an in-process research and development charge representing the net value of the assets exchanged for the intellectual property assets acquired from Teva, as well as related transaction and drug product costs. Excluding these costs, research and development costs would have increased in 2016 as compared to 2015 by $12.7 million, primarily due to an $8.0 million increase in the development costs associated with the company’s entrectinib, taladegib, and other product candidates. The remaining increase in costs between periods was due to personnel expenses related to hiring and engaging additional employees and consultants to help advance the company’s product candidates.

General and administrative expenses were $5.2 million for first quarter of 2016, compared with $2.8 million for first quarter of 2015. The increase was primarily caused by increases in personnel costs, as well as higher facilities-related expenses resulting from the expansion of the company’s leased facilities space. The increase was also attributable to increases in legal and intellectual property costs, consulting fees, and depreciation expenses.

At March 31, 2016, the company had cash, cash equivalents, and available-for-sale securities totaling $151.2 million and current and long-term debt of approximately $31.0 million. This balance does not include the gross proceeds of $57.5 million from the May 2016 underwritten public offering. At December 31, 2015, the company had cash, cash equivalents, and available-for-sale securities totaling $172.1 million and current and long-term debt of $31.0 million.

On May 10, 2016 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the first quarter of 2016 and updated financial guidance for 2016 (Filing, Q1, Jazz Pharmaceuticals, 2016, MAY 10, 2016, View Source [SID:1234512492]).

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"During the first quarter of 2016, we executed on our business model by delivering strong top- and bottom-line growth and commenced promotion of Defitelio in the U.S. immediately following FDA approval. Defitelio is the first and only approved treatment in the U.S. for patients who develop hepatic VOD with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation," said Bruce C. Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals plc. "For 2016, we will continue to invest in the organic growth of our key products, including new indications, and the advancement of our development pipeline. Diversification of our product portfolio through internal and corporate development efforts remains a high priority as we seek to identify and acquire differentiated and long-lived therapeutic options for patients."

Adjusted net income for the first quarter of 2016 was $141.0 million, or $2.26 per diluted share, compared to $125.1 million, or $1.99 per diluted share, for the first quarter of 2015.

GAAP net income for the first quarter of 2016 was $74.1 million, or $1.19 per diluted share, compared to $70.7 million, or $1.12 per diluted share, for the first quarter of 2015. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included in this press release.

Financial Highlights

Three Months Ended March 31,

(In thousands, except per share amounts and percentages)
2016

2015

Change
Total revenues
$
336,010

$
309,303

8.6
%
Adjusted net income
$
140,995

$
125,068

12.7
%
GAAP net income
$
74,121

$
70,700

4.8
%
Adjusted EPS
$
2.26

$
1.99

13.6
%
GAAP EPS
$
1.19

$
1.12

6.3
%

Total Revenues
Total revenues were as follows:

Three Months Ended March 31,
(In thousands)
2016

2015
Xyrem (sodium oxybate) oral solution
$
249,537

$
212,690

Erwinaze / Erwinase (asparaginase Erwinia chrysanthemi)
51,173

50,353

Defitelio (defibrotide sodium) / defibrotide
17,897

17,363

Prialt (ziconotide) intrathecal infusion
6,209

6,764

Psychiatry
7,002

9,093

Other
2,098

10,772

Product sales, net
333,916

307,035

Royalties and contract revenues
2,094

2,268

Total revenues
$
336,010

$
309,303

Net product sales increased by 9% in the first quarter of 2016 compared to the same period in 2015 primarily due to higher net product sales of Xyrem.
Erwinaze/Erwinase net product sales increased by 2% in the first quarter of 2016 compared to the same period in 2015. Although Erwinaze net product sales increased, as a consequence of constrained manufacturing capacity, the company has had a limited ability to build sufficient inventory levels that can be used to absorb supply disruptions. In the first quarter of 2016, the company experienced supply challenges that temporarily disrupted its ability to supply certain markets.
Defitelio/defibrotide product sales increased by 3% in the first quarter of 2016 compared to the same period in 2015. The increase in net product sales was partially offset by the impact of foreign exchange on sales made in euro.

Operating Expenses
Operating expenses were as follows:

Three Months Ended March 31,
(In thousands, except percentages)
2016

2015
GAAP:

Cost of product sales
$
23,439

$
28,298

Gross margin
93.0
%

90.8
%
Selling, general and administrative
$
128,765

$
112,388

% of total revenues
38.3
%

36.3
%
Research and development
$
31,252

$
27,181

% of total revenues
9.3
%

8.8
%
Acquired in-process research and development
$
8,750

$
—

Non-GAAP adjusted:

Cost of product sales
$
22,640

$
27,603

Gross margin
93.2
%

91.0
%
Selling, general and administrative
$
102,611

$
95,041

% of total revenues
30.5
%

30.7
%
Research and development
$
27,962

$
23,696

% of total revenues
8.3
%

7.7
%

Operating expenses changed over the prior year period primarily due to the following:
•
Selling, general and administrative (SG&A) expenses increased in the first quarter of 2016 compared to the same period in 2015, on a GAAP and non-GAAP adjusted basis, primarily due to higher headcount and other expenses resulting from the expansion of the company’s business.
•
Research and development (R&D) expenses increased in the first quarter of 2016 compared to the same period in 2015, on a GAAP and non-GAAP adjusted basis, primarily due to higher costs for clinical studies and outside services for the development of JZP-110 and line extensions for the company’s existing products.
•
Acquired in-process research and development (IPR&D) expense in the first quarter of 2016 related to an upfront payment of $8.8 million the company made in connection with its acquisition of intellectual property and know-how related to recombinant crisantaspase.

Cash Flow and Balance Sheet
As of March 31, 2016, cash, cash equivalents and investments were $980.5 million, and the outstanding principal balance of the company’s long-term debt was $1.3 billion. Cash, cash equivalents and investments decreased during the quarter primarily due to repurchases under the company’s share repurchase program, partially offset by cash generated by the business. During the first quarter of 2016, the company repurchased 1.1 million ordinary shares for $134.4 million, at an average cost of $123.77 per ordinary share.
In March 2016, the company recorded a $150.0 million milestone owed to Sigma-Tau Pharmaceuticals, Inc., which was triggered by the U.S. Food and Drug Administration approval of Defitelio on March 30, 2016. The milestone was capitalized as an intangible asset and was paid by the company in April 2016.

2016 Financial Guidance
Jazz Pharmaceuticals is updating its full year 2016 financial guidance, which is as follows (in millions, except per share amounts and percentage):
Revenues
$1,490-$1,550
Total net product sales
$1,482-$1,542
-Xyrem net sales
$1,095-$1,130
-Erwinaze/Erwinase net sales
$200-$225
-Defitelio/defibrotide net sales
$100-$125
Adjusted gross margin %1,4
93%
Adjusted SG&A expenses2,4
$390-$410
Adjusted R&D expenses3,4
$115-$130
GAAP net income per diluted share
$6.76-$7.41
Non-GAAP adjusted net income per diluted share*,4
$11.10-$11.50
_____________________________
*
Updated May 10, 2016 to reflect a decrease in weighted-average shares to 62 million.
1.
Excludes $6 million of share-based compensation expense from estimated GAAP gross margin of 93%.
2.
Excludes $87-$95 million of share-based compensation expense and $6 million of expenses related to certain legal proceedings and restructuring from estimated GAAP SG&A expenses of $483-$511 million.
3.
Excludes $17-$19 million of share-based compensation expense from estimated GAAP R&D expenses of $132-$149 million.
4.
See "Non-GAAP Financial Measures" below. Reconciliations of non-GAAP adjusted guidance measures are included above and in the tables accompanying this press release.

Tokalas’ first lead product candidate, TK-216, is a novel, first-in-class ets-family transcription factor inhibitor that targets the EWS-FLI1 fusion protein (Company Web Page, Tokalas, MAY 10, 2016, View Source [SID:1234512166]). Oncogenic fusion proteins involving ets-family gene translocations are known to cause Ewing sarcoma, the company’s first targeted therapy for high unmet need cancers.

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TK-216 is based on technology developed under the direction of Jeffrey Toretsky, M.D. at Georgetown University and licensed to Tokalas through an academic-private development partnership. IND enabling non-clinical studies of TK-216 have been completed, and Tokalas will initiate Phase 1 clinical testing in patients with advanced Ewing sarcoma in early 2016 at MD Anderson, Memorial Sloan Kettering, and UCLA. Tokalas is exploring expedited registration strategies with both US and European regulatory agencies.
Tokalas is also evaluating the unmet medical need in other cancers that sometimes carry overexpressed or translocated ets-family oncogenes, including prostate cancer, AML, and glioblastoma.

On May 10, 2016 Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, reported results for its second quarter ended March 31, 2016 (Press release, Ohr Pharmaceutical, MAY 10, 2016, View Source [SID:1234512219]).

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"We achieved a number of important milestones in advancing our lead drug candidate, Squalamine, during the first few months of 2016," said Jason S. Slakter, MD, Chief Executive Officer of Ohr. "In commencing the enrollment of patients in our Phase 3 clinical program, we move closer to potentially providing a much-needed, safe and efficacious new treatment for patients with neovascular age-related macular degeneration or wet AMD. Importantly, we are conducting the Phase 3 trials under an agreed upon Special Protocol Assessment (SPA) with the United States Food and Drug Administration. The trials are designed to generate data to support regulatory approval of Squalamine in the United States and other major ophthalmic markets worldwide."

Second Quarter and Recent 2016 Clinical and Pre-Clinical Highlights

Enrolled the first patient in the Phase 3 clinical development program to investigate Squalamine lactate ophthalmic solution, 0.2% ("Squalamine," also known as OHR-102), when administered as part of a combination therapy, as a treatment to improve visual function for patients with wet AMD.
The Phase 3 program includes two clinical trials designed as double-masked, placebo-controlled, multicenter, international studies of Squalamine administered twice a day in patients with newly diagnosed wet AMD, in combination with Lucentis injections.
The first of the two randomized trials will include approximately 165 centers in the United States and Canada and has a target enrollment of 650 treatment naïve subjects with wet AMD.
The primary endpoint in both studies will be a measurement of visual acuity gains at nine months, which is the most clinically meaningful endpoint for wet AMD patients. Subjects will be followed to two years for safety.
Reached an agreement on a Special Protocol Assessment (SPA) with the United States Food and Drug Administration on the design of the Phase 3 trials for Squalamine.
Presented two posters at the Association for Research in Vision and Ophthalmology (ARVO) Conference, which took place May 1 through May 5 in Seattle, Washington.
CNV Lesion Characteristics as a Predictor of Visual Outcomes in Wet AMD Patients Receiving Combination Therapy with Ranibuzimab (Lucentis) and topical Squalamine Lactate Ophthalmic Solution (David M. Brown et al). Included detailed analysis of lesion characteristics as predictors of visual outcome in the previously conducted Phase 2 IMPACT trial, and demonstrated that combination therapy with Squalamine was most effective in those patients whose occult component was less than 10mm2. These new data support the choice of the target population in the ongoing Phase 3 registration program.
Sustained Retinal Concentrations of OHR3031 Achieved with Intravitreal Injection of a Biodegradable Microparticle Formulation to Rabbits (Modi et al). This poster discussed the use of Ohr’s proprietary sustained release technology to successfully deliver supratherapeutic concentrations of OHR3031, a novel small molecule anti-angiogenic compound, to target tissues in the back of the eye.
Financial Results for Second Quarter ended March 31, 2016

For the second quarter ended March 31, 2016, the Company reported a net loss of approximately $5.3 million, or ($0.17) per share, compared to a net loss of approximately $3.4 million, or ($0.12) per share in the same period of 2015.
For the second quarter ended March 31, 2016, total operating expenses were approximately $6.6 million, consisting of approximately $3.0 million in general and administrative expenses, $4.0 million in research and development expenses, $0.3 million in depreciation and amortization, and $0.7 million in gain on settlement of accounts payable. This compares to total operating expenses in the same period of 2015 of approximately $6.8 million, consisting of $3.3 million in general and administrative expenses, $3.2 million in research and development expenses, and $0.3 million in depreciation and amortization.
At March 31, 2016, the Company had cash and cash equivalents of approximately $21.9 million. This compares to cash and equivalents of approximately $28.7 million at September 30, 2015.
Financial Results for the Six-Months ended March 31, 2016

For the six months ended March 31, 2016, the Company reported a net loss of approximately $11.4 million, or ($0.37) per share, compared to a net loss of approximately $7.9 million, or ($0.30) per share in the same period of 2015.
For the six months ended March 31, 2016, total operating expenses were approximately $10.2 million, consisting of $4.2 million in general and administrative expenses, $6.1 million of research and development expenses, $0.6 million in depreciation and amortization, and $0.7 million in gain on settlement of accounts payable. This compares to total operating expenses of $10.7 million in the same period of 2015, comprised of approximately $4.2 million in general and administrative expenses, $5.9 million in research and development expenses, and $0.6 million in depreciation and amortization.