On May 10, 2018 Athersys, Inc. (NASDAQ:ATHX) reported its financial results for the three months ended March 31, 2018 (Press release, Athersys, MAY 10, 2018, View Source [SID1234526466]).

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Highlights of the first quarter of 2018 and recent events include:

Completed a $21.1 million equity investment and announced plans to expand the HEALIOS K.K. ("Healios") collaboration by June 1, 2018. This proposed expansion includes a $10 million license fee funded in an escrow account and a potential additional $25 million of committed payments over time, as well as additional possible payments including milestones and royalties, if the collaboration is fully expanded in accordance with the letter of intent disclosed in March 2018;
Advanced our preparations for the MASTERS-2 Phase 3 registration study for ischemic stroke to enable initiation of this important study and supported the continued enrollment of Healios’ TREASURE study;
Progressed Phase 1/2 study evaluating MultiStem therapy in acute respiratory distress syndrome (ARDS) patients;
Announced plans with The University of Texas Health Science Center at Houston to conduct a Phase 2 clinical trial evaluating MultiStem cell therapy for early treatment and prevention of complications after severe traumatic injury;
Established a new equity facility with Aspire Capital Fund LLC, as a follow-on to a prior facility, providing the Company with access to additional capital as needed to support its ongoing operations;
Recognized revenues of $1.1 million for the quarter ended March 31, 2018 and a net loss of $10.2 million, or $(0.08) per share; and
Ended the 2018 first quarter with $49.7 million of cash and cash equivalents, excluding the $10 million in escrow from Healios related to the proposed collaboration expansion.
"We finished the first quarter in a strong financial position, with approximately $50 million on the balance sheet and look forward to building on that as we work to complete the expansion of our partnership with Healios," commented Dr. Gil Van Bokkelen, Chairman & CEO at Athersys. "As we and Healios recently disclosed, we have extended the timeline to complete the agreements to expand our collaboration until the end of May, and we are working together to achieve that goal.

"We are also focused on preparing for the upcoming initiation of our MASTERS-2 trial, while we continue to support the ongoing TREASURE trial in Japan," added Dr. Van Bokkelen. "In addition, we have been advancing our other clinical programs and broadening our portfolio of new opportunities, as evidenced by the recent announcement related to a clinical study in trauma. This represents another significant area of unmet clinical need that we are now well-positioned to pursue with funding support from the Medical Technology Enterprise Consortium and our collaborator, UTHealth," concluded Dr. Van Bokkelen.

First Quarter Results

Revenues decreased to $1.1 million for the three months ended March 31, 2018 compared to $1.5 million for the three months ended March 31, 2017 . Our revenues are comprised of revenue from manufacturing-related activities for Healios, royalty and related contract revenue from our collaboration with RTI Surgical, Inc. and grant revenue. Our revenue from Healios increased during the first quarter of 2018 compared to the prior year first quarter by approximately $0.3 million as we continue to supply clinical product to Healios and provide other manufacturing-related services, and we expect these revenues will be higher for the 2018 annual period as compared to the 2017 year. Regarding our royalty revenue, excluding a $1.0 million milestone payment from RTI in the 2017 first quarter, royalty revenues increased by approximately $0.2 million in the first quarter of 2018 as a result of an increase in the royalty rate that became effective late 2017 associated with our technology license to RTI. Grant revenue varies from period-to-period with new and completed grants, and the timing of grant-funded activities. Absent new grant awards, we expect our annual grant revenue to decline in 2018 from 2017 with the expiration of certain grant-funded programs.

Research and development expenses increased to $8.9 million for the three months ended March 31, 2018 from $5.6 million in the comparable period in 2017. The $3.3 million increase is primarily comprised of an increase in preclinical and clinical development costs of $2.7 million, an increase in personnel costs of $0.3 million, and an increase in internal research supplies and other research costs of $0.3 million. The increase in our clinical and preclinical costs is primarily a result of increased process development activities to support large-scale manufacturing and clinical product manufacturing costs during the period.

General and administrative expenses increased to $2.7 million for the three months ended March 31, 2018 from $2.1 million in the comparable period in 2017. The $0.6 million increase was due primarily to an increase of $0.3 million in professional fees and increases in personnel costs, stock-based compensation costs and other administrative costs compared to the same period last year.

Net loss was $10.2 million in 2018 compared to $5.6 million in 2017. The difference of $4.6 million reflects the above variances, as well as $0.4 million in insurance proceeds that we received this quarter, which were offset by a $0.7 million non-cash gain related to the fair value of our warrant liabilities recorded in the first quarter of 2017 for warrants that expired in 2017. The warrant issued in March 2018 to Healios in connection with its equity investment was treated as equity with its value recorded as additional paid-in capital with an offset in other current assets.

Net cash used in operating activities was $5.7 million for the three months ended March 31, 2018 and $5.4 million for the three months ended March 31, 2017, reflecting the increased net loss in the first quarter of 2018 (i.e., cash used to fund preclinical and clinical development activities) compared to the prior year period, as offset in part by proceeds received from Healios for our cost-share arrangement for clinical product supply and an increase in accounts payable due to service providers, such as contract manufacturers, under longer-term contracts. As of March 31, 2018, we had $49.7 million in cash and cash equivalents, compared to $29.3 million at December 31, 2017, which includes, among other things, the investment made by Healios in March 2018 and excludes the $10 million that Healios has funded into an escrow account to be released to us upon execution of the expansion agreements.

Conference Call

Gil Van Bokkelen, Chairman and Chief Executive Officer, and William (BJ) Lehmann, President and Chief Operating Officer, will host a conference call today to review the results as follows:

Date Thursday, May 10, 2018
Time 4:30 p.m. (Eastern Time)
Telephone access: U.S. and Canada 800-273-1254
Telephone access: International 973-638-3440
Access code 1189915
Live webcast www.athersys.com, under the Investors section
A replay will be available for on-demand listening shortly after the completion of the call until 11:59 PM Eastern Time on May 24, 2018 at the aforementioned URL, or by dialing (800) 585-8367 or (855) 859-2056 in the U.S. and Canada, or from abroad (404) 537-3406, and entering access code 1189915.

About MultiStem

MultiStem cell therapy is a patented regenerative medicine product in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors produced in response to signals of inflammation and tissue damage. MultiStem therapy’s potential for multidimensional therapeutic impact distinguishes it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. The therapy represents a unique "off-the-shelf" stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. Based upon its efficacy profile, its novel mechanisms of action, and a favorable and consistent safety profile demonstrated in clinical studies, MultiStem therapy could provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need.

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 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.

On May 10, 2018 Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported its first quarter financial results for 2018 (Press release, Intrexon, MAY 10, 2018, View Source [SID1234526485]).

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Intrexon Corporation logo. (PRNewsFoto/Intrexon Corporation)

First Quarter 2018 Business HighlightsPrecigen, Inc., and ActoBio Therapeutics, Inc., began operating as standalone entities effective January 1, 2018 and are now wholly owned subsidiaries of Intrexon;
Intrexon’s Energy team demonstrated successful third party catalytic conversion of 2,3 BDO to 1,3 butadiene. The conversion efficiency exceeded both the Company’s financial model and synthetic rubber industry product quality expectations;
ActoBio Therapeutics and collaborator Intrexon T1D Partners, LLC, have been granted allowance by the U.S. Food & Drug Administration (FDA) for their Investigational New Drug (IND) application to initiate a Phase Ib/IIa study for the treatment of early onset type 1 diabetes with AG019, an innovative disease-modifying approach to induce immune tolerance;
Exemplar Genetics, a wholly owned subsidiary of Intrexon, announced the FDA exercised enforcement discretion clearing for commercial use as a research model the ExeGen ATM MiniSwine, which is genetically engineered to model ataxia telangiectasia (AT), a rare, inherited, predominantly neurological human disease. Following Exemplar’s previous approval of its ExeGen LDLR MiniSwine model for use in cardiovascular disease research, the ExeGen ATM model is the second engineered MiniSwine model reviewed and cleared by the FDA;
Okanagan Specialty Fruits (OSF), a wholly owned subsidiary of Intrexon, launched the sales of dried Arctic Goldens – Arctic ApBitz apple snacks – via Amazon;
Intrexon’s Industrial Products Division has demonstrated microbial production of cannabinoids that has potential to provide >20-fold reduction in Cost Of Goods with reduced environmental impacts for THC and CBD versus current synthetic and extraction-based routes;
Collaborator Fibrocell Science, Inc. (NASDAQ: FCSC) obtained allowance from the FDA to begin clinical trials for FCX-013, its gene therapy candidate for the treatment of moderate to severe localized scleroderma; and
In January, Intrexon sold 6,900,000 shares of its common stock in an underwritten public offering at a public offering price of $12.50 per share, including the exercise in full by the underwriters of their option to purchase an additional 900,000 shares of common stock. Gross proceeds to Intrexon from the offering were approximately $86.3 million before deducting the underwriting discount and other offering expenses payable by Intrexon.
Recent Developments:

2,3 BDO yields are up 25% since last reported and the rate of yield improvement is in line with Intrexon’s expectations and supports the Company’s plans to break ground on a 40,000 ton/year facility by year end;
Isobutanol yields are again improving and are up about 40% since last reported. This return to yield improvements for isobutanol was the result of the re-design of a promiscuous enzyme that was degrading product and making further optimization of the production pathway challenging;
Partnering activity concerning Intrexon’s methane bioconversion platform is robust with multiple parties engaged. Potential partners include both strategic and financial companies;
Xogenex, a majority-owned subsidiary of Precigen, has opened and is actively recruiting patients its Phase 1 trial of the gene therapy INXN-4001, which the company believes is the world’s first multigene cardiac therapeutic candidate expressing proteins from three effector genes for the treatment of heart disease;
OSF has completed the planting of 520,000 of the 600,000 Arctic apple trees planned for the year; and
AquaBounty Technologies, Inc. (NASDAQ: AQB), a majority-owned subsidiary of Intrexon, received FDA approval of its recirculating aquaculture system (RAS) salmon production facility in Indiana and is ready to commence U.S. production, pending final adoption of the recently released labeling standards issued by the United States Department of Agriculture.
First Quarter 2018 Financial Highlights:

Total revenues of $43.8 million, a decrease of 18% from the first quarter of 2017;
Net loss of $42.0 million attributable to Intrexon, or $(0.33) per basic share, including non-cash charges of $26.3 million;
Adjusted EBITDA of $(19.7) million, or $(0.15) per basic share;
The net change in deferred revenue related to upfront and milestone payments, which represents the cash and stock received from collaborators less the amount of revenue recognized during the period, was a decrease of $13.6 million compared to a decrease of $10.2 million in the first quarter of 2017; and
Cash, cash equivalents, and short-term investments totaled $120.2 million, the value of preferred shares totaled $166.1 million, and the value of common equity securities totaled $14.0 million at March 31, 2018.
"It was a solid quarter of execution throughout our company," commented Randal J. Kirk, Chairman and Chief Executive Officer of Intrexon. "Our partnering activities, now focusing on larger transactions with major players on our more mature programs and platforms, are gaining traction and momentum so the balance of the year is coming into focus for us in a satisfying way. Simultaneously, we saw that the Arctic ApBitz snacks of Okanagan Specialty Fruits genuinely delight customers as we had hoped, while the future availability of AquaBounty’s AquAdvantage salmon in U.S. markets took a major step forward."

Mr. Kirk concluded, "While getting products from our mature programs and platforms into commerce remains a great focus of our senior team, I must say that my gratitude and respect goes out especially to our scientific teams, several of which recently have been responsible for a number of ‘world first instance’ matters of true significance. This is especially so for our Energy team who seem to have solved a tremendously baffling technical issue that had been impeding further progress on isobutanol for several months."

First Quarter 2018 Financial Results Compared to Prior Year Period

Total revenues decreased $9.9 million, or 18%, from the quarter ended March 31, 2017. Collaboration and licensing revenues decreased $9.0 million from the quarter ended March 31, 2017 primarily due to the decrease in research and development services for certain of the Company’s exclusive channel collaborations, or ECCs, as the Company redeployed certain resources towards supporting prospective new platforms and partnering opportunities and began to focus more on the further development of relationships and structures that provide the Company with more control and ownership over the development process and commercialization path. This decrease was partially offset by the accelerated recognition of the remaining balance of previously deferred revenue related to the Company’s ECC with OvaScience, Inc., or OvaScience, which was mutually terminated in March 2018. Product revenues decreased $1.0 million, or 12%, primarily due to lower customer demand for cows and live calves combined with lower sales prices on cows. Gross margin on products declined in the current period as a result of increased operating costs associated with new product offerings.

Research and development expenses increased $3.1 million, or 9%, due primarily to increases in (i) salaries, benefits and other personnel costs for research and development employees and (ii) depreciation and amortization. Salaries, benefits and other personnel costs increased $1.5 million due to an increase in research and development headcount necessary to invest in current or expanding platforms and increased compensation expenses related to performance and retention incentives for research and development employees. Depreciation and amortization increased $1.2 million primarily as a result of (i) the amortization of developed technology acquired from GenVec, Inc., in June 2017, and (ii) additional research and development assets placed in service in 2017 at Oxitec. Selling, general and administrative (SG&A) expenses increased $4.6 million, or 13%. Salaries, benefits and other personnel costs increased $6.2 million primarily due to (i) increased headcount to support the Company’s expanding operations, (ii) increased compensation expenses related to performance and retention incentives for SG&A employees, and (iii) higher stock-based compensation expense due to the inclusion in the quarter ended March 31, 2017, of the reversal of previously recognized stock-based compensation expense for stock options granted to the Company’s former President who resigned in March 2017 as well as incremental stock-based compensation expenses associated with new equity grants issued in 2018. Legal and professional fees decreased $2.3 million primarily due to (i) decreased legal fees associated with ongoing litigation and (ii) decreased fees incurred for regulatory and other consultants.

The decrease in equity in net loss of affiliates of $2.5 million, or 50%, was directly related to the decrease in collaboration revenues from collaborators in which Intrexon owns an equity-method interest.

Conference Call and Webcast

The Company will host a conference call today Thursday, May 10th, at 5:30 PM ET to discuss the first quarter 2018 financial results and provide a general business update. The conference call may be accessed by dialing 1‑888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1-412-317-6061 (International) and providing the number 3130312 to join the Intrexon Corporation Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source