On May 10, 2018 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQX:IGXT) (the "Company" or "IntelGenx") reported financial results for the first quarter ended March 31, 2018 (Press release, IntelGenx, MAY 10, 2018, View Source [SID1234526484]). All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2018 First Quarter Financial Highlights:

Total revenue was $239,000, which reflected decreases in deferred and upfront revenues of $922,000 and 408,000, respectively.
Adjusted EBITDA was ($1.8 million), compared to adjusted EBITDA of ($117,000) in the same period last year.
Cash and short-term investments totalled $2.4 million as at March 31, 2018, which did not include gross proceeds of $3.2 million raised by the Company in its May 2018 unit offering.
Recent Developments:

Presented overviews of the Company’s business at the 10th Annual Biotech Showcase in January 2018 and at the Bloom Burton & Co. Healthcare Investor Conference in May 2018.
Initiated Phase 2a proof of concept Montelukast VersaFilm clinical trial in Alzheimer’s patients, following clearance of the Clinical Trial Application by Health Canada. IntelGenx retained the services of Cogstate and JSS Medical Research as the Contract Research Organizations to support the Montelukast VersaFilm study. Patient screening is expected to begin in Q2 2018.
"With the completion of the private placement offering earlier this week, we now have sufficient financial resources to support our Montelukast Phase 2a clinical trial and to continue advancing the rest of our product pipeline toward commercialization," commented Dr. Horst G. Zerbe, President and CEO of IntelGenx.

Financial Results:

Total revenues for the three-month period ended March 31, 2018 amounted to $239,000, compared to $1.4 million for the three-month period ended March 31, 2017. The decrease for the three-month period ended March 31, 2018 compared to the last year’s corresponding period is mainly attributable to a decrease in deferred revenues on monetization of $922,000 and a decrease in upfront revenues of $408,000, partially offset by an increase in Research and Development revenues of $218,000.

Operating costs and expenses were $2.3 million for the first quarter ended March 31, 2018, versus $1.8 million for the corresponding quarter in 2017. The increase for the three-month period ended March 31, 2018 is mainly attributable to a $153,000 increase in Research and Development expenses and a $376,000 increase in mostly non-recurring Selling, General and Administrative expenses.

For the first quarter ended March 31, 2018, the Company had an operating loss of $2.0 million, compared to an operating loss of $457,000 for the comparable period of 2017.

Net comprehensive loss was $2.3 million, or $0.03 on a basic and diluted per share basis, for the three-month period ended March 31, 2018, compared to a net comprehensive loss of $468,000, or $0.01 on a basic and diluted per share basis, for the comparable period of 2017.

As of March 31, 2018, the Company’s cash and short-term investments totalled $2.4 million, which did not include gross proceeds of $3.2 million raised in its May 2018 unit offering.

Conference Call Details:

IntelGenx will host a conference call to discuss its first quarter 2018 financial results today, May 10, 2018, at 4:30 p.m. ET. The dial-in number for the conference call is (833) 231-8269. The call will be webcast live and archived for twelve months at www.intelgenx.com

On May 10, 2018 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will present at the upcoming UBS Global Healthcare Conference taking place May 21-23, 2018 in New York, NY, USA (Press release, Zymeworks, MAY 10, 2018, View Source [SID1234526500]).

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The Company will present on Monday, May 21, 2018 at 2:00 p.m. ET. Interested parties can access a live webcast of the presentation via a link from Zymeworks’ website at View Source, which will also host a recorded replay available afterwards.

On May 10, 2018 STORM Therapeutics, the drug discovery company focused on the discovery of small molecule therapies modulating RNA epigenetics, reported that it will be giving a company presentation at Bio€quity Europe 2018, Ghent, Belgium, 14 – 16 May 2018 (Press release, STORM Therapeutics, MAY 10, 2018, View Source [SID1234561044]).

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Keith Blundy, CEO of STORM Therapeutics will be presenting on Wednesday, 16 May 2016 at 9:10am CEST in Rector Gillis Suit, Level 1, Het Pand, Onderbergen 1, Ghent, Belgium.

Now celebrating its 19th meeting, Bio€quity Europe is the seminal industry event for financial dealmakers looking for investor-validated life science companies positioning themselves to attract capital, and for pharmaceutical licensing professionals to assess top prospects. Bio€quity Europe has showcased more than 700 leading European companies to thousands of investment and pharma business development professionals.

Osiris Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On May 10, 2018 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported its financial results for the first quarter ended March 31, 2018 (Press release, Calithera Biosciences, MAY 10, 2018, View Source [SID1234526468]). As of March 31, 2018, cash, cash equivalents and investments totaled $171.2 million.

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"In the first quarter we continued to work towards our goal of developing CB-839 as a potential new treatment option for advanced renal cell carcinoma," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "We are currently enrolling a registration-enabling randomized double-blind placebo controlled trial of CB-839 with cabozantinib for the treatment of renal cell carcinoma and have received Fast Track designation from the FDA for this trial."

First Quarter 2018 and Recent Highlights

CB-839

Preclinical Combination Data Demonstrate Synergy of CB-839 with CDK4/6 and PARP inhibitors. In April 2018, we presented results at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrating that CB-839 has synergistic anti-proliferative activity when combined with a CDK4/6 inhibitor in colorectal carcinoma (CRC), triple negative breast cancer (TNBC), and ER+ breast cancer cell lines. CB-839 treatment in combination with PARP inhibitors has synergistic anti-proliferative activity in TNBC, CRC, non-small cell lung carcinoma, ovarian and prostate cancer cells. In vivo, the combination of CB-839 with PARP inhibitors or the CDK4/6 inhibitor each enhanced anti-tumor activity in animal models.

Initiated Randomized Phase 2 of CB-839 in Combination with Cabozantinib in Renal Cell Carcinoma. At the 2018 Genitourinary Cancer Symposium in February, we presented preliminary results of the Phase Ib trial of CB-839 in combination with cabozantinib, an oral tyrosine kinase inhibitor, showing that the combination demonstrated a 40% overall response rate in advanced clear cell RCC patients and a 100% disease control rate, with the safety profile of CB-839 plus cabozantinib generally consistent with that of cabozantinib monotherapy. On the basis of this efficacy and safety data, we initiated a randomized double-blind placebo controlled trial, known as CANTATA, comparing patients treated with cabozantinib and CB-839 to patients treated with cabozantinib alone. This trial will enroll approximately 300 clear cell renal cell carcinoma patients who have previously received one or two prior lines of therapy. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CB-839 in combination with cabozantinib for the treatment of this patient population. In parallel, the ENTRATA trial, a randomized double-blind placebo-controlled study of later line patients, is enrolling approximately 66 patients to receive either everolimus and CB-839 or everolimus alone.

Abstracts Accepted for Presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). A phase 1 Investigator sponsored clinical trial of CB-839 plus capecitabine has been accepted for poster presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).1 In addition, Calithera and clinical collaborators will present two trials-in-progress abstracts, which describe the design of ongoing studies.
INCB001158

Enrolling INCB001158 Clinical Trials. INCB001158 is being evaluated in multiple clinical trials for the treatment of patients with solid tumors both as a monotherapy, and in combination with immunotherapies and chemotherapy. INCB001158 is being developed as part of a collaboration and license agreement with Incyte.
Selected First Quarter 2018 Financial Results

Cash, cash equivalents and investments totaled $171.2 million at March 31, 2018.

Collaboration revenue for the first quarter of 2018 was $5.2 million, compared with $4.2 million for the same period in the prior year, and represents the portion of deferred revenue recognized from our collaboration and license agreement with Incyte. The increase of $1.0 million was primarily due to a full quarter of activity in 2018 verses a partial quarter in 2017, partially offset by differences in accounting due to our adoption of the accounting standard related to revenue from contracts with customers, or ASC 606, on January 1, 2018.

Research and development expenses were $15.4 million for the three months ended March 31, 2018, compared with $6.6 million for the same period in the prior year. The increase of $8.8 million was primarily due to a $7.6 million increase in our CB-839 program to support our new and ongoing clinical trials, including our three Phase 2 trials, as well as an increase of $1.0 million from investment in our early stage research programs, and an increase of $0.2 million from our INCB001158 program.

General and administrative expenses were $3.5 million for the three months ended March 31, 2018, compared with $3.3 million for the same period in the prior year. The increase of $0.2 million was primarily due to $1.0 million in higher personnel-related costs, partially offset by $0.4 million of lower costs associated with entering into the Incyte agreement and $0.4 million lower expenses due to the execution of a sublease agreement for office and laboratory space, both in the first quarter of 2017.

Net loss for the three months ended March 31, 2018 was $13.2 million, or $0.37 per share.