On November 12, 2019 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported its financial results for the third quarter ended September 30, 2019, and provided an update on its programs and progress (Press release, Synlogic, NOV 12, 2019, View Source [SID1234550963]).

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"We are making good progress towards our goal of evaluating the breadth of therapeutic applications of our Synthetic Biotic platform. Notably, the recent initiation of the first clinical trial of a Synthetic Biotic medicine for the treatment of cancer represents a significant step for Synlogic," said Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief executive officer. "We also continue to advance our SYNB1618 program for the treatment of phenylketonuria in an ongoing bridging study to evaluate the tolerability and activity of a solid oral formulation, and we look forward to sharing those data and our plans for the next steps in this program."

Recent Highlights
Pipeline

Clearance of Investigational New Drug (IND) application and initiation of SYNB1891 immuno-oncology (IO) clinical study. Synlogic has initiated a Phase 1 open-label, multicenter, dose escalation trial of its STING-agonist producing bacterial strain, SYNB1891, for the treatment of refractory solid tumors. The study’s primary objectives are to evaluate safety and tolerability of escalating doses of intratumorally administered SYNB1891 as a monotherapy. Once a maximum tolerated dose is established, patients will receive escalating dose levels of SYNB1891 in combination with a fixed dose of the checkpoint inhibitor, Atezolizumab, to establish a recommended Phase 2 dose for the combination regimen. Synlogic expects to have data from the monotherapy arm of the study in 2020.
Presentation of positive data from Phase 1/2a Study of SYNB1618 in patients with phenylketonuria (PKU) as well as modeling work to estimate target dosing of SYNB1618. In September, clinical data from a randomized, double-blind, placebo-controlled Phase 1/2a study of SYNB1618, which is being developed for the treatment of PKU were presented at the Annual Symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM) by Jerry Vockley, M.D. Ph.D., Professor of Pediatrics and Chief of Medical Genetics, University of Pittsburgh, and a principal investigator on the trial. The study’s primary objective was to evaluate safety and tolerability and to measure biomarkers of phenylalanine-consuming activity of multiple ascending doses of a liquid formulation of SYNB1618 in healthy volunteers and a single dose level in PKU patient cohorts. SYNB1618 was well tolerated in healthy volunteers and patients with PKU and the data demonstrated equivalent phenylalanine-consumption.
Initiation of bridging study of a solid oral formulation of SYNB1618 in healthy volunteers to establish maximum tolerated dose (MTD) for efficacy study in patients with PKU. Based on data from its Phase 1/2a study of a liquid formulation of SYNB1618, Synlogic initiated a bridging study in healthy volunteers of a new solid oral formulation to establish an MTD that would potentially enable at least a 30% lowering of blood Phe levels in PKU patients based on the company’s modeling data. With supporting data from the bridging study, Synlogic expects to advance SYNB1618 into an efficacy study in patients in the first half of 2020.
Corporate

Key appointments to Synlogic’s leadership and research and development teams
Richard Riese, M.D. Ph.D., chief medical officer, joined Synlogic in September and has assumed responsibilities for all clinical and regulatory functions from current president and CEO, Aoife Brennan.
Gregg Beloff, interim chief financial officer, was appointed in October 2019. Mr. Beloff, who has more than 20 years of experience in the life sciences industry, brings significant expertise in operational management, strategic planning, corporate and business development, fundraising and mergers and acquisitions.
Third Quarter 2019 Financial Results
As of September 30, 2019, Synlogic had cash, cash equivalents, and short- and long-term investments of $138.7 million. The Company anticipates that, based on its current operating plan, its existing cash and cash equivalents will fund company operations through 2021.

For the three months ended September 30, 2019, Synlogic reported a consolidated net loss of $13.3 million, or $0.39 per share, compared to a consolidated net loss of $10.7 million, or $0.43 per share, for the corresponding period in 2018.

Research and development expenses were $10.6 million for the three months ended September 30, 2019 compared to $9.9 million for the corresponding period in 2018. The increase was primarily due to increased clinical development costs for our SYNB1618 program.

General and administrative expenses for the three months ended September 30, 2019 were $3.9 million compared to $3.4 million for the corresponding period in 2018.

Revenues were $0.3 million for the three months ended September 30, 2019, compared to $1.8 million for the corresponding period in 2018. The revenue for both periods is associated with Synlogic’s collaboration with AbbVie to develop a Synthetic Biotic medicine for the treatment of inflammatory bowel disease. The decrease in revenue was primarily the result of the achievement of a $2.0 million milestone under a September 2018 amendment to the AbbVie agreement of which $1.8 million was recognized in revenue in the quarter ended September 30, 2018.

Conference Call & Webcast Information
Synlogic will host a conference call and live webcast today at 5:00 p.m. ET today, Tuesday, November 12, 2019. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Alternatively, investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or +1 (213) 660-0926 from outside the United States. The conference ID number is 3889667. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors and Media section of the Synlogic website.

On November 12, 2019 Adaptive Biotechnologies Corporation ("Adaptive Biotechnologies") (Nasdaq: ADPT) reported financial results for the quarter ended September 30, 2019 (Press release, Adaptive Biotechnologies, NOV 12, 2019, View Source [SID1234550979]).

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"During the third quarter, we continued to make strong progress across our existing products and our pipeline," said Chad Robins, chief executive officer and co-founder of Adaptive. "We are encouraged to see increasing demand for clonoSEQ as we continue developing the market and expanding our label. We were also excited to confirm our first clinical signal for immunoSEQ Dx, proving that we can read and translate how the adaptive immune system diagnoses disease."

Recent Highlights

Revenue of $26.1 million for the third quarter of 2019, an increase of 52% over the third quarter of 2018

Achieved milestone for immunoSEQ Dx with confirmation of the first clinical signal in acute Lyme disease

Entered into a partnership for use of the clonoSEQ Assay as preferred MRD test for drug development across Amgen’s hematology franchise

Entered into a partnership with Illumina to enable the development of IVD test kits for our diagnostic products

Third Quarter 2019 Financial Results

Revenue was $26.1 million for the quarter ended September 30, 2019, representing a 52% increase from the third quarter in the prior year. Sequencing revenue was $11.7 million for the quarter, representing a 38% increase from the third quarter in the prior year. Development revenue increased to $14.4 million for the quarter, representing a 65% increase from the third quarter in the prior year.

Operating expenses were $44.1 million for the third quarter of 2019, compared to $26.3 million in the third quarter of the prior year, representing an increase of 68%.

Net loss was $14.0 million for the third quarter of 2019, compared to $8.3 million for the same period in 2018.

Adjusted EBITDA (non-GAAP) was a loss of $12.7 million for the third quarter of 2019, compared to a loss of $5.1 million for the third quarter of the prior year.

Cash, cash equivalents and marketable securities was $708.7 million as of September 30, 2019.

2019 Financial Guidance

Management will provide updates to the 2019 revenue outlook on the conference call scheduled to discuss the third quarter 2019 financial results.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its third quarter 2019 financial results after market close on Tuesday, November 12, 2019 at 4:30 PM Eastern Time. The conference call can be accessed live over the phone (800) 361-2311 for U.S. callers or (409) 937-8761 for international callers (Conference ID: 3698520). The webcast can be accessed at View Source

On November 12, 2019 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, reported financial results for the quarter ended September 30, 2019, and provided an update on recent clinical developments (Press release, Scynexis, NOV 12, 2019, View Source [SID1234550997]). Ibrexafungerp (formerly SCY-078), the first representative of a novel family of compounds referred to as triterpenoids, is being developed for oral and intravenous administration and is in clinical development for the treatment of several serious fungal infections, including vulvovaginal candidiasis (VVC), invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections. If approved, ibrexafungerp would be the first agent approved for the treatment of VVC and prevention of recurrent VVC and the only oral alternative to azoles.

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"We are thrilled with the positive top-line results from the VANISH-303 study and are increasingly confident in an anticipated NDA submission for the treatment of VVC next year as we work to bring ibrexafungerp, potentially the first new class of antifungals approved in over 20 years, to patients in need," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We believe the VVC market is quite large and underserved by existing agents, with only one FDA-approved oral drug in the market, which has lacked innovation since the introduction of fluconazole in the 1990s. We’re confident in the commercial potential of ibrexafungerp given its differentiated attributes as a new oral, non-azole antifungal and the eagerness of women with VVC and their treating physicians to try new therapies."

Dr. Taglietti continued: "We are also enthusiastically advancing our hospital-based development programs of ibrexafungerp as a novel treatment to fight invasive, increasingly drug-resistant and often life-threatening fungal infections, such as Candida auris. As part of this effort, we recently announced the expansion of our FURI protocol to a broader range of refractory, serious fungal infections that are potentially eligible for a limited-population FDA approval under the LPAD regulatory pathway. Given the robust evidence collected to date across all of our programs, we believe ibrexafungerp can have the same positive impact fluconazole had when it was first introduced nearly 30 years ago, leveraging ibrexafungerp’s versatility and strong attributes in many different treatment settings – from women’s health with VVC to deadly, hospital-based infections."

Ibrexafungerp Update

Positive top-line data reported for the first of two studies in the VANISH Phase 3 program evaluating the safety and efficacy of oral ibrexafungerp (300mg BID for one day) versus placebo as a treatment for women with VVC
SCYNEXIS recently announced positive results from the VANISH-303 study, a Phase 3, randomized, double-blind, placebo-controlled, study that enrolled 376 patients at 28 U.S. centers. These results were reported earlier than originally anticipated due to rapid enrollment in the study.
The primary endpoint required for registration is clinical cure, defined as complete resolution (score of 0) of all signs and symptoms (S&S) at the Day-10 test-of-cure (TOC) visit. The observed clinical cure for ibrexafungerp was 50.5%, showing highly statistically significant superiority to placebo (p=0.001). Mycological eradication (secondary endpoint) at TOC in ibrexafungerp patients was 49.5%, also showing superiority to placebo (p<0.001). Clinical improvement (S&S score of 0 or 1) at TOC, another secondary endpoint that is a clinically relevant assessment of treatment response, was achieved in 64.4% of ibrexafungerp patients (p<0.001 against placebo). The VANISH-303 ibrexafungerp efficacy results confirm results observed in the Phase 2b DOVE study and achieve the superiority versus placebo required for regulatory approval.
Oral ibrexafungerp was generally safe and well tolerated. Severe and serious adverse events (AEs) were rare, with more cases reported in the placebo group than the ibrexafungerp group, and there were no drug-related serious AEs. The majority of Treatment-Emergent AEs (TEAEs) observed at a higher frequency in the ibrexafungerp group were gastrointestinal in nature, with the three most common GI events (diarrhea/loose stool, nausea and abdominal pain) occurring at rates of 25.5%, 16.6% and 7.3%, respectively, similar to the rates seen in the Phase 2b DOVE study. These events were predominantly regarded as mild, of short duration and did not lead to discontinuation.
A second global Phase 3 study (VANISH-306), with identical design, is being conducted in the U.S. and Europe. Enrollment continues to progress rapidly, and the Company anticipates top-line data early in the second quarter of 2020. The combined results from the VANISH-303 and VANISH-306 pivotal studies are expected to provide the safety and efficacy data to support a New Drug Application (NDA) for ibrexafungerp for the treatment of VVC, with submission to the U.S. Food and Drug Administration (FDA) planned in the second half of 2020.

Ongoing enrollment in Phase 3 CANDLE study evaluating the safety and efficacy of oral ibrexafungerp versus placebo for the prevention of recurrent VVC
The CANDLE study is a global Phase 3, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of oral ibrexafungerp (300mg BID for one day, given once per month for a total of six treatment days) compared to placebo in female patients with recurrent VVC (defined as three or more episodes of VVC in the past 12 months, including the episode at screening). The study is being conducted at approximately 50 sites and is expected to enroll approximately 320 patients. Pending a positive outcome, the Company anticipates filing a supplemental NDA for the prevention of recurrent VVC with the FDA in 2021.

Continued advancement of oral ibrexafungerp for hospital-based, invasive fungal infections with two Phase 3 studies (FURI in refractory infections and CARES in Candida auris infections) and one Phase 2 study in invasive aspergillosis (SCYNERGIA)
The protocol for the FURI study, investigating the safety and efficacy of oral ibrexafungerp as a salvage treatment for patients with resistant or refractory severe fungal infections, was expanded to include a broader range of infections. Under the amended study design, patients with aspergillosis, coccidioidomycosis, histoplasmosis, blastomycosis and infections caused by other emerging fungi, including yeasts and molds, are now eligible for enrollment along with those suffering from Candida infections. Additionally, the maximum allowed duration of treatment with ibrexafungerp has been extended from 90 days to up to 180 days, as needed, for chronic conditions. Ibrexafungerp will also be available as a combination therapy with standard of care for selected patients.
Continued and expanded patient enrollment is expected to support future NDA submissions and potential approval through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). The Company anticipates reporting a second interim data review from the FURI study by an independent data review committee in the first quarter of 2020.
Enrollment is ongoing for the CARES and SCYNERGIA studies.

Data presented at 3rd International Society of Infectious Diseases in Obstetrics and Gynecology (ISIDOG), IDWeek 2019 and the 9th Congress on Trends in Medical Mycology (TIMM-9) further highlighting the scientific and clinical evidence of ibrexafungerp’s activity against multiple fungal pathogens
Post-hoc data from the Phase 2b DOVE study presented at ISIDOG 2019 highlighted ibrexafungerp’s improved trend in signs and symptoms versus fluconazole on a per patient basis.
Data presented at IDWeek 2019 highlighted a large body of evidence demonstrating the activity and efficacy of ibrexafungerp against Candida auris, both in vivo and in vitro.
In an oral presentation at TIMM-9, studies demonstrating ibrexafungerp’s broad spectrum of activity against Candida, Aspergillus, and Pneumocystis were presented, along with evidence of its activity against resistant organisms and ibrexafungerp’s potential utility for the treatment of hospital-based resistant and refractory fungal infections. Additional posters presented provided in vitro, in vivo and clinical evidence of ibrexafungerp’s broad utility against multiple fungal pathogens.
Corporate Highlight

SCYNEXIS received notification from the State of New Jersey of its available unused Net Operating Losses (NOLs) and R&D credits and expects to receive approximately $3.3 million in cash by the end of 2019.
The New Jersey Economic Development Authority’s (NJEDA) Technology Business Tax Certificate Transfer (NOL) Program allows eligible companies to sell their New Jersey NOLs and research and development tax credits up to a maximum lifetime benefit of $15 million per company. This may be the second non-dilutive NOL-related cash injection through the NJEDA for SCYNEXIS. In January 2019, SCYNEXIS announced the receipt of approximately $6.7 million of net cash proceeds through the sale of unused New Jersey NOLs.
Third Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments totaled $28.1 million as of September 30, 2019, with net working capital of $20.9 million. Based upon its existing operating plan, SCYNEXIS believes its existing cash, cash equivalents, short-term investments, and the sale of a portion of its New Jersey NOLs, may enable SCYNEXIS to fund operating requirements past an anticipated NDA submission for acute VVC in the second half of 2020.

Research and development expenses increased to $9.3 million for the quarter ended September 30, 2019, compared to $3.9 million in the third quarter of 2018. The increase of $5.3 million, or 136%, was primarily driven by an increase of $4.1 million in clinical development costs, an increase of $0.7 million in chemistry, manufacturing, and controls (CMC) costs, and a net increase in other research and development costs of $0.5 million.

Selling, general and administrative expenses in the third quarter of 2019 increased to $2.5 million, compared with $2.4 million in the third quarter of 2018.

Total other income decreased to $3.8 million in the third quarter of 2019, compared to $6.7 million in the third quarter of 2018. The decrease in other income is attributable to a $6.9 million non-cash gain recorded on the fair value adjustment of the warrant liabilities during the third quarter of 2018.

Net loss for the third quarter of 2019 was $7.9 million. This compares with net income for the third quarter of 2018 of $0.4 million.

About Ibrexafungerp
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species. It has demonstrated broad spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia), invasive aspergillosis (IA) and VVC (including prevention of recurrent VVC) and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

On November 12, 2019 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the third quarter ended September 30, 2019 (Press release, VolitionRX, NOV 12, 2019, View Source [SID1234551013]). Volition management will host a conference call tomorrow, November 13, at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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Cameron Reynolds, President and Chief Executive Officer of Volition, upon releasing these results, commented, "I could not be more proud of our dedicated team at Volition, and the ground-breaking work we are doing. I’m happy to say that we have made excellent progress this quarter on our platform development, Nu.Q Capture, Nu.Q Vet and our colorectal cancer and lung cancer trials, particularly in Asia, and we reported our first revenues from sales of Research Use Only kits and the provision of contract research services.

We are an epigenetics company focused on advancing the science of epigenetics and exploiting these advances in human and animal health. This has been our mission since our founding, and it is coming to fruition with our Nu.Q platform at the very heart of epigenetics. We believe the last decade of work and our extensive intellectual property portfolio puts Volition in a strong position to be a significant player in this field by launching multiple products."

Click here to view an interview with Volition’s Chief Executive Officer.

Mr. Reynolds further commented, "We aim to strengthen our product pipeline beyond colorectal cancer to cover several cancers, most notably in lung cancer, and so are especially delighted to have commenced two studies in lung cancer this quarter, firstly our large-scale study in lung cancer with the National Taiwan University and secondly our first study in China with Shanghai Fosun Long March Medical Science Co. Ltd. We have also expanded our colorectal cancer work with a first trial in China underway with Fosun.

"I am also delighted to announce that subsequent to quarter end we executed a contract with Texas A&M University to collaborate on the research and development of Nu.Q Vet products and help drive early revenue in the all-important veterinary market."

Additionally, Mr. Reynolds added, "During the third quarter 2019, we further strengthened our balance sheet with an existing investor exercising $4.8 million in aggregate amount of outstanding warrants to purchase shares of our common stock making a total of $16.5 million in warrants exercised during the first three quarters of 2019 and ended the quarter with cash and cash equivalents of $19.7 million. During the third quarter we were awarded a further $1.4 million in non-dilutive grant-funding from the Walloon Region and, subsequent to quarter end, an additional $500,000 unsecured loan from SOFINEX was approved. We also recorded our first revenues this quarter from sales of our Research Use Only kits and the provision of services."

Company Highlights

Financial

Cash and cash equivalents as of September 30, 2019 totaled $19.7 million compared to $13.4 million as of the end of 2018.
Recorded first revenues from the sales of our Research Use Only kits and from the provision of sample processing services to a third party.
Continued to manage cash carefully with an average quarterly cash burn rate over the first three quarters of 2019 of approximately $3.6 million.
Clinical Trials

Commenced our first large-scale lung cancer study in conjunction with the prestigious National Taiwan University ("NTU"). The study is being conducted under the supervision of Professor Chen Jin-Shing in the Department of Surgery of NTU and will include 1,200 subjects receiving Low-Dose Computed Tomography scans. We expect the first data from this trial in the first half of 2020.
Commenced our first studies in China for both lung and colorectal cancer with Shanghai Fosun Long March Medical Science Co. Ltd.
Organizational

Completed the formation of a U.S.-based majority-owned subsidiary, Volition Veterinary Diagnostics Development LLC, to drive the development and commercialization of Nu.Q Vet products and appointed its Chief Executive Officer, Mr. Nathan Dewsbury.
Executed agreements with Texas A&M University’s College of Veterinary Medicine to collaborate on the research and development of Nu.Q Vet products.
Made strong progress in platform development, including the appointment of a Clinical Validation Expert with more than 15 years of experience in adapting assays to automated machines to greatly broaden our product platform range.
Intellectual Property

Achieved steady growth in our worldwide patent portfolio. We believe that this is a key differentiator versus many other technologies either under development or available on the market, where the patent position may be poor and/or narrow.
20 patent families related to our diagnostic tests (including both human and veterinary medicine applications).
8 patents granted in the United States.
7 patents granted in the European Union.
25 further patents granted worldwide.
106 patents pending worldwide.
Upcoming Milestones

We expect to achieve the following milestones during 2019 and through 2020:

Announce the results of multiple proof of concept cancer studies, starting in December 2019 and continuing throughout 2020.
Complete the CE Marking of IVD kits for cancer triage tests.
Advance our previously announced large-scale colorectal and lung cancer trials with a significant number of assays on the highly analytically accurate automated platform(s).
Announce preliminary results of Nu.Q’s performance in other disease conditions.
Advance the development of Nu.Q Capture by determining the level of discrimination of tumor associated nucleosomes using immunoassays and sequencing.
Through Volition Veterinary and the collaboration with Texas A&M, complete the pre-analytical and discovery studies to determine and announce the route to revenue for Nu.Q Vet products.
Submit abstracts and clinical papers for publication from our Nucleosomics work in a wide range of areas.
Mr. Reynolds concluded, "We are extremely proud of the accomplishments we have achieved thus far. I thank the dedicated Volition team for their tireless efforts. I, along with the rest of the Board and indeed the whole company, look forward to sharing our progress and the results of key studies over the remainder of 2019 and throughout 2020."

For further details please contact [email protected].

VolitionRx Limited Third Quarter 2019 Earnings
and Business Update Conference Call

Date: Wednesday, November 13, 2019
Time: 8:30 a.m. U.S. Eastern time
U.S. & Canada Dial-in: 1-877 407 9716 (toll free)
U.K. Dial-in: 0 800 756 3429 (toll free)
Toll/International: 1-201 493 6779
Conference ID: 13696533
Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with David Vanston, Chief Financial Officer and Scott Powell, Executive Vice President, Investor Relations. The call will provide an update on recent developments and Volition’s activities, including details of new and ongoing clinical trials, important events which have taken place in the third quarter of 2019, and milestones for 2019 and beyond.

On November 12, 2019 Intrexon Corporation (NASDAQ: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported its third quarter financial results for 2019 (Press release, Intrexon, NOV 12, 2019, View Source [SID1234551028]).

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Recent Business Highlights:

In Intrexon Health:

Precigen, Inc., a wholly owned subsidiary of Intrexon, continues to advance its clinical and pre-clinical portfolios. Details about Precigen accomplishments will be highlighted during a conference call and webcast today at 11:00 AM ET;
Triple-Gene LLC, a majority owned subsidiary of Intrexon, completed patient enrollment and dosing for the second cohort in its Phase 1 clinical trial of INXN-4001, an investigational new drug which is the world’s first triple effector gene drug candidate being evaluated for the treatment of heart failure, and expects to present preliminary data at the American Heart Association Scientific Sessions November 16-18th in Philadelphia;
ActoBio Therapeutics, Inc., a wholly owned subsidiary of Intrexon, received a greenlight from the independent Data and Safety Monitoring Board to open the randomized part of the adult combination cohort and the open-label part of the adolescent combination cohort in its Phase Ib/IIa clinical trial of AG019 for the treatment of early onset type 1 diabetes. ActoBio’s collaboration partner Oragenics, Inc. (NYSE American: OGEN) continues patient recruitment in the Phase 2 trial of AG013 for the treatment of severe oral mucositis and anticipates completion of enrollment by the end of the fourth quarter 2019;
Exemplar Genetics, a wholly owned subsidiary of Intrexon, formed a collaboration with Lovelace Biomedical to continue development of Exemplar’s porcine animal model for sickle cell disease with support from the National Center for Advancing Translational Sciences;
Collaborator PTC Therapeutics, Inc. (NASDAQ: PTCT) announced its intention to file an Investigational New Drug submission for its gene therapy candidate for Friedreich ataxia in mid-2020; and
With two clinical stage collaboration product candidates, collaborator Fibrocell Science, Inc. (NASDAQ: FCSC) announced it is being acquired by Castle Creek Pharmaceutical Holdings, with the transaction expected to close in Q4, 2019. Proceeds to Intrexon are due upon the closing.
In Intrexon Bioengineering:

Intrexon appointed David H. Witte, formerly of IHS Markit, as Chief Executive Officer of MBP Titan LLC, a standalone subsidiary company of Intrexon comprising Intrexon’s Methane Bioconversion Platform (MBP) with its associated technologies, personnel, and facilities. Intrexon transferred substantially all of its proprietary assets related to MBP to this new entity and, under Mr. Witte’s leadership, MBP will seek investment to fund its capital needs. Intrexon and Governor David Dewhurst, Chairman Designate of MBP Titan, have agreed that Governor Dewhurst will participate in this financing in lieu of his previous commitment;
Okanagan Specialty Fruits, a wholly owned subsidiary of Intrexon, completed the 2019 harvest of Arctic Goldens and Arctic Grannies yielding an estimated 6,800 bins (6 million pounds) of apples, a 3.5-fold increase over 2018;
Oxitec, Ltd., a wholly owned subsidiary of Intrexon, initiated a pilot project for releases of its 2nd Generation Friendly Aedes aegypti technology in Indaiatuba, Brazil. Additionally, the US Environmental Protection Agency (EPA) closed the comment period on Oxitec’s Experimental Use Permit (EUP) application to conduct pilot projects on its 2nd generation Friendly Aedes aegypti technology in Florida and Texas. Oxitec is coordinating with EPA leadership on its application and contingent upon regulatory approval, anticipates mosquito releases would commence in 2020. Oxitec also received a cash payment from the Bill & Melinda Gates Foundation for completing certain developmental milestones;
Intrexon closed its Animal Sciences Division and Cell Engineering Unit; and
Effective October 29, 2019, Intrexon entered into a stock purchase agreement with TS AquaCulture, LLC, an affiliate of Third Security, LLC, for the sale of 8,239,199 shares of AquaBounty Technologies, Inc. (NASDAQ: AQB), representing all of Intrexon’s ownership interests in AquaBounty, for an aggregate purchase price of approximately $21.6 million.
Corporate Matters:

Intrexon continues its discussions and negotiations with multiple parties concerning the sale or disposition of numerous business units and assets;
Randal J. Kirk, Chairman and Chief Executive Officer of Intrexon, has also made a non-binding offer to purchase for cash all non-healthcare assets, including Intrexon Bioengineering, although there is no certainty that any transaction with Mr. Kirk will be entered into or consummated, and any such transaction would be subject to negotiation and approval by an independent committee of Intrexon’s Board of Directors; and
Intrexon believes that the Company has options available to allow it to achieve, without the sale of equity, binding commitments with respect to its yearend cash goal of $175 million, allowing it to begin 2020 with a tighter focus on Health and especially around Precigen.
There are risks and uncertainties inherent in forecasts of this nature, including with respect to the challenges in identifying and negotiating with counterparties, transactions taking longer or generating lower proceeds than expected, changes in strategic directions, general market developments, costs and expenses being higher than anticipated, developments in clinical, market or competitive data, and other factors of the type generally applicable to the Company’s business, including those discussed under the Safe Harbor Statement below.

Third Quarter 2019 Financial Highlights:

Total revenues of $23.0 million;
Net loss of $53.6 million attributable to Intrexon, or $(0.35) per basic share, including non-cash charges of $19.5 million; and
Cash, cash equivalents, and short-term investments totaled $89.7 million and the value of common equity securities totaled $22.8 million at September 30, 2019.
Year-to-Date 2019 Financial Highlights:

Total revenues of $82.4 million;
Net loss of $153.1 million attributable to Intrexon, or $(1.00) per basic share, including non-cash charges of $47.7 million.
"Intrexon’s longstanding focus on Health and, in particular, in cancer therapeutics may be vindicated as Precigen’s clinical programs further develop," commented Mr. Kirk.

Mr. Kirk concluded, "When I became CEO in 2009, when the company entered into its first collaboration in 2011, when it IPO’d in 2013 and through last year’s reacquisition of the vast majority of its commercial rights pertaining to its cancer therapeutics programs, healthcare has been our greatest area of investment and potential. When Helen Sabzevari joined us in 2017 as President of Precigen, truly the repository of the original Intrexon technology as well as its most substantial technology acquisitions, we saw great potential if these technologies could be unlocked by a great drug development team. Today we begin to share with the world what Helen and her team have accomplished and, equally importantly, to let you hear this formidable pharmaceutical executive tell you this in her own words."

Third Quarter 2019 Financial Results Compared to Prior Year Period

Total revenues decreased $9.4 million from the quarter ended September 30, 2018. Collaboration and licensing revenues decreased $8.1 million, or 57%, from the quarter ended September 30, 2018 primarily due to the reacquisition of rights previously licensed to some of Intrexon’s most significant collaborators in the second half of 2018 and the result of which eliminated or substantially reduced revenues previously generated from those collaborations. Additionally, collaboration and licensing revenues from collaborations with other collaborators decreased due to lower demand for research and development services in the current year period.

Research and development expenses decreased $13.4 million, or 30%. The 2018 amounts include an $8.7 million expense related to in-process research and development reacquired as part of an asset acquisition in September 2018. Additionally, depreciation and amortization decreased $2.2 million primarily due to intangible assets that were impaired or abandoned in 2018. Selling, general and administrative (SG&A) expenses decreased $14.0 million, or 36%, and of this amount, $11.2 million was primarily attributable to (i) decreased compensation expenses related to performance and retention incentives for SG&A employees and (ii) decreased share-based compensation expense which arose primarily from the departure of former employees during the first half of the current year.

Year-to-Date 2019 Financial Results Compared to Prior Year Period

Total revenues decreased $35.0 million from the nine months ended September 30, 2018. Collaboration and licensing revenues decreased $30.4 million, or 59%, from the nine months ended September 30, 2018 primarily due to the reacquisition of rights previously licensed to some of Intrexon’s most significant collaborators in the second half of 2018 and the result of which eliminated or substantially reduced revenues previously generated from those collaborations. Product revenues decreased $5.0 million, or 21%, primarily due to lower customer demand. Gross margin on products also declined in the current period for the same reason.

Research and development expenses decreased $25.0 million, or 20%. The 2018 amounts include (i) an $8.7 million expense related to in-process research and development reacquired as part of an asset acquisition in September 2018 and (ii) $5.3 million of one-time costs associated with closing one of Oxitec’s research and development facilities as the Company decentralized operations previously conducted in this facility. Additionally, depreciation and amortization decreased $6.5 million primarily due to intangible assets that were impaired or abandoned in 2018. SG&A expenses decreased $33.1 million, or 29%, and of this amount, $26.7 million was primarily attributable to (i) decreased share-based compensation expense which arose primarily from the departure of former employees as well as a result of certain stock option grants becoming fully vested in 2018 and (ii) decreased compensation expenses related to performance and retention incentives for SG&A employees.

Conference Call and Webcast

Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients and a wholly owned subsidiary of Intrexon, will host a conference call today Tuesday, November 12th at 11:00 AM ET to provide Precigen business and pipeline updates. 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 4454504 to join the Precigen Business and Pipeline Update Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source or Precigen’s website in the Presentations section at View Source