On November 8, 2018 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, reported financial results for the third quarter ended September 30, 2018 and provided a summary of recent events (Press release, Regulus, NOV 8, 2018, View Source [SID1234531200]).

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Third Quarter 2018 Corporate Highlights and Recent Updates

Amended and restructured its Collaboration and License Agreement with Sanofi: In November, Regulus and Sanofi agreed to restructure their Collaboration and License Agreement and immediately transfer development responsibilities of RG-012 for the treatment of Alport syndrome to Sanofi. Sanofi will assume all future costs and development activities associated with the advancement of RG-012, currently in Phase 2 for the treatment of Alport syndrome. Under the terms of the Amendment, Regulus is eligible to receive approximately $7 million in upfront and material transfer payments. Regulus is also eligible to receive up to $40 million in development milestone payments, including a $10 million payment for an interim enrollment milestone. In addition, Sanofi will reimburse Regulus for certain out-of-pocket expenses associated with transition activities and assume Regulus’ upstream license royalty obligations.

Initiated new chronic mouse toxicity study for RGLS4326; data anticipated in Q1 2019: In September 2018, and in consultation with the FDA, the Company initiated a new 27-week chronic mouse toxicity study for RGLS4326 for the treatment of autosomal dominant polycystic kidney disease (ADPKD), incorporating several changes believed to address the unexpected findings in the earlier terminated chronic mouse toxicity study. This study is ongoing, and data are anticipated in Q1 2019. The Company anticipates the advancement of the RGLS4326 clinical program upon successful resolution of the unexpected findings.

Completed reverse stock split and regained compliance with NASDAQ listing requirements: In a special meeting of stockholders, held September 28, 2018, stockholders voted to approve a proposal authorizing the Board of Directors of the Company to amend the Company’s certificate of incorporation to affect a reverse stock split of Regulus’ outstanding common shares. Following the special meeting of stockholders, the Board of Directors approved a 1-for-12 reverse stock split. The Company’s shares began trading on a split-adjusted basis on October 4, 2018. On October 18, 2018, The Nasdaq Stock Market notified Regulus that it had regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Global Market.

"The recently announced Sanofi restructuring represents a significant achievement for Regulus, bringing non-dilutive capital and eliminating future spend for this partnered program. Importantly, we are eligible to receive approximately $17 million in upfront and milestone payments anticipated over the next twelve months," said Jay Hagan, President and Chief Executive Officer of Regulus. "In July, we established several near-term key objectives, including reducing our cash burn, restructuring the Sanofi collaboration, advancing our prioritized pipeline, including ADPKD, and positioning other programs for business development opportunities. Regulus has made significant progress towards completing all of these objectives, and we look forward to the continued advancement of our ADPKD and HBV programs."

Program Updates

Presented preclinical data supporting RGLS4326 as a novel therapeutic for the treatment of ADPKD at the American Society of Nephrology’s Kidney Week 2018: In October 2018, Regulus presented three posters during the American Society of Nephrology’s Kidney Week describing the discovery and preclinical evaluation of RGLS4326, a novel single-stranded, chemically-modified oligonucleotide designed to preferentially target the kidney and inhibit miR-17 functions to treat ADPKD. In preclinical studies, RGLS4326 inhibited miR-17 activity and reduced cyst formation and proliferation of primary cyst cultures derived from human donors with ADPKD. The data presented also demonstrated that RGLS4326 has favorable pharmacokinetic and pharmacodynamic profiles in normal and polycystic kidney disease (PKD) mouse models, where preferential distribution to kidney and localization to collecting duct cysts were evident. Furthermore, data demonstrated that RGLS4326 directly modulates expression of genes implicated in ADPKD pathogenesis including Pkd1 and Pkd2, and conferred efficacy in multiple PKD mouse models following subcutaneous administration.

Advancement of Hepatitis B virus (HBV) Programs: The Company has identified multiple human microRNA targets that serve as host factors for the virus. Compounds directed at modulating these targets are under active in vitro and in vivo preclinical investigation. The Company believes that targeting a host factor in the liver represents a unique mechanism of action for treatment of the virus compared to other programs in development and holds the potential for achieving a functional cure. The Company currently expects to file an IND for the HBV program in the second half of 2019, with the potential of achieving human proof-of-concept in a Phase 1 study.

Additional Program Updates: In September 2018, the Company announced progress of its glioblastoma multiforme (GBM) and non-alcoholic steatohepatitis (NASH) preclinical programs. The Company’s GBM program, targeting microRNA-10b, demonstrated statistically significant improvements in survival as both a monotherapy as well as in combination with temozolomide (TMZ) in an orthotopic GBM animal model. The Company’s lead NASH candidate demonstrated improvement in key endpoints, including NAFLD Activity Score (NAS), liver transaminases, hyperglycemia, and disease-related gene expression. In the diet-induced NASH mouse model (Amylin model) after 2-4 weekly doses, early onset of improvement across multiple disease parameters including liver triglycerides and blood levels of transaminases was observed. The Company plans to seek partners to further advance these programs’ development.

Third Quarter 2018 Financial Results

Cash Position: As of September 30, 2018, Regulus had $20.5 million in cash, cash equivalents and short-term investments. Under the terms of the Sanofi Amendment, Regulus is eligible to receive approximately $7 million in upfront and material transfer payments. Including these additional proceeds, the Company expects its cash runway to extend through Q2 2019.

Research and Development (R&D) Expenses: R&D expenses were $6.9 million and $28.7 million for the three and nine months ended September 30, 2018, respectively, compared to $12.7 million and $42.7 million for the same periods in 2017. The decreases were primarily attributable to the pausing of the RG-012 and RGLS4326 programs early in the third quarter of 2018, the discontinuation of the RG-101 and RGLS5040 programs in 2017 and reductions in personnel-related expenses primarily attributable to our corporate restructurings.

General and Administrative (G&A) Expenses: G&A expenses were $3.0 million and $10.1 million for the three and nine months ended September 30, 2018, respectively, compared to $2.7 million and $13.8 million for the same periods in 2017. The increase for the three months ended September 30, 2018 as compared to the three months ended September 30, 2017 was driven by non-recurring severance charges recorded in the third quarter of 2018 in connection with our July 2018 corporate restructuring. The decrease for the nine months ended September 30, 2018 as compared to the nine months ended September 30, 2017 was driven by non-recurring severance charges and non-recurring, non-cash stock-based compensation charges recorded in connection with our May 2017 corporate restructuring.

Revenue: Revenue was less than $0.1 million for each of the three and nine months ended September 30, 2018 and 2017.

Net Loss: Net loss was $10.3 million, or $1.18 per share (basic and diluted), and $40.1 million, or $4.62 per share (basic and diluted), for the three and nine months ended September 30, 2018, respectively, compared to $15.8 million, or $2.11 per share (basic and diluted), and $57.5 million, or $10.52 per share (basic and diluted), for the same periods in 2017. Historical and current period net loss per share values have been retroactively adjusted to reflect our October 2018 reverse stock split.

Upcoming Events

On November 14, 2018, Regulus will present survival data on its lead anti-miR candidate targeting microRNA-10b for glioblastoma multiforme at the Society for Neuro-Oncology Meeting in New Orleans, Louisiana.

On November 14, 2018, Regulus will present a corporate overview at the Stifel 2018 Healthcare Conference in New York.

On November 8, 2018 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported financial results for the three and nine months ended September 30, 2018, and provided an operating forecast and program updates (Press release, Ligand, NOV 8, 2018, View Source [SID1234530958]). Ligand management will host a conference call today beginning at 9:00 a.m. Eastern time to discuss this announcement and answer questions.

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"This quarter was marked by several events that demonstrate the strength of Ligand’s business model. First, our partners continued to deliver solid commercial and clinical development results. Specifically, sales of Promacta hit an all-time quarterly high and our partner Viking Therapeutics announced positive topline results for its Phase 2 trial of VK2809, with the potential for efficacy in patients with liver diseases such as non-alcoholic fatty liver disease and NASH. Additionally, we closed the acquisition of Vernalis in October, which provides several high-value shots on goal, as well as a top-notch R&D team, all for a modest cash outlay," said John Higgins, Chief Executive Officer of Ligand. "Despite the recent turbulence in the financial markets, Ligand continues to execute on its business model, and we will remain focused and will work to capitalize on opportunities the economic cycle brings us."

Third Quarter 2018 Financial Results

Total revenues for the third quarter of 2018 were $45.7 million, compared with $33.4 million for the same period in 2017. Royalties were $36.1 million, compared with $21.9 million for the third quarter of 2017 and $28.3 million for the fourth quarter of 2017. Under the new accounting standard ASC 606, adopted as of the start of 2018, third quarter 2018 royalties should be compared with fourth quarter 2017 royalties due to the timing of revenue recognition. Third quarter 2018 royalties primarily consisted of royalties from Promacta, Kyprolis and EVOMELA. Material sales were $7.0 million, compared with $7.7 million for the same period in 2017 due to the timing of Captisol purchases for use in clinical trials and commercial products. License fees, milestones and other revenues were $2.5 million, compared with $3.8 million for the same period in 2017.

Cost of goods sold was $1.5 million for the third quarter of 2018, compared with $2.4 million for the same period in 2017. Amortization of intangibles was $5.7 million, compared with $2.7 million for the same period in 2017, due to recent acquisitions and amortization of R&D assets that were out-licensed or impaired. Research and development expense was $5.5 million, compared with $4.8 million for the same period of 2017. General and administrative expense was $9.6 million, compared with $7.0 million for the same period in 2017.

GAAP net income for the third quarter of 2018 was $67.4 million, or $2.80 per diluted share, compared with $8.4 million, or $0.36 per diluted share, for the same period in 2017. Net income for the third quarter of 2018 was impacted by a non-cash gain due to the marking of Ligand’s investment in Viking Therapeutics to market. Adjusted net income for the third quarter of 2018 was $31.7 million, or $1.32 per diluted share, compared with $15.3 million, or $0.69 per diluted share, for the same period in 2017.

As of September 30, 2018, Ligand had cash, cash equivalents, restricted cash and short-term investments of approximately $1 billion. Cash generated from operations during the third quarter of 2018 was $27.1 million.

Year-to-Date Financial Results

Total revenues for the nine months ended September 30, 2018 were $191.9 million, compared with $90.6 million for the same period in 2017. Royalties were $88.3 million, compared with $60.4 million for the nine months ended September 30, 2017 and $64.5 million for the nine months ended December 31, 2017. Under ASC 606, royalties for the nine months ended September 30, 2018 should be compared with royalties for the nine months ended December 31, 2017 due to the timing of revenue recognition. Royalties for the nine months ended September 30, 2018 primarily consisted of royalties from Promacta, Kyprolis and EVOMELA. Material sales were $19.0 million, compared with $14.3 million for the same period in 2017 due to the timing of Captisol purchases for use in clinical trials and commercial products. License fees, milestones and other revenues were $84.5 million, compared with $15.9 million for the same period in 2017, primarily due to the receipt of a $47 million payment from WuXi Biologics to amend its OmniAb platform license agreement and a $20 million upfront payment upon the licensing of Ligand’s GRA program.

Cost of goods sold was $3.4 million for the nine months ended September 30, 2018, compared with $3.6 million for the same period in 2017 due to the timing and mix of Captisol sales. Amortization of intangibles was $12.3 million, compared with $8.1 million for the same period in 2017, due to recent acquisitions and amortization of R&D assets that were out-licensed or impaired. Research and development expense was $19.0, compared with $18.3 million for the same period in 2017. General and administrative expense was $26.6 million, compared with $20.9 million for the same period in 2017.

GAAP net income for the nine months ended September 30, 2018 was $185.8 million, or $7.61 per diluted share, compared with $19.6 million, or $0.84 per diluted share, for the same period in 2017. Net income for the nine months ended September 30, 2018 was impacted by a non-cash gain due to the marking of Ligand’s investment in Viking Therapeutics to market. Adjusted net income for the nine months ended September 30, 2018 was $127.9 million, or $5.44 per diluted share, compared with $42.9 million, or $1.94 per diluted share, for the same period in 2017.

2018 Financial Guidance

Ligand is raising its previous guidance for 2018 and now expects revenue to be approximately $240 million, including royalties of approximately $122 million, material sales of approximately $25 million and license fees and milestones of approximately $93 million, with the potential for up to an additional $5 million in license fees and milestones. Ligand notes that with revenue of $240 million, adjusted earnings per diluted share would be approximately $6.52.

This compares with previous guidance for 2018 revenue to be approximately $232 million, including royalties of approximately $120 million, material sales of approximately $23 million and license fees and milestones of approximately $89 million, with the potential for up to an additional $8 million in license fees and milestones, and adjusted earnings per diluted share of approximately $6.30.

Third Quarter 2018 and Recent Business Highlights

Promacta/Revolade

Novartis reported third quarter 2018 net sales of Promacta/Revolade (eltrombopag) of $295 million, a $68 million or 30% increase over the same period in 2017.
Novartis presented data from a Phase 4 open-label study of Promacta in the treatment of Chronic Immune Thrombocytopenia at the European Congress on Thrombosis and Haemostasis 2018.
Novartis announced that Promacta would be highlighted at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2018.
Kyprolis (carfilzomib), an Amgen Product Utilizing Captisol

On October 30, 2018, Amgen reported third quarter net sales of Kyprolis of $232 million, a $25 million or 12% increase over the same period in 2017. On October 31, 2018, Ono Pharmaceutical reported Kyprolis sales in Japan of approximately $11 million for the most recent quarter.
On October 1, 2018, Amgen announced that the FDA approved the supplemental New Drug Application (sNDA) to expand the prescribing information for Kyprolis to include a once-weekly dosing option in combination with dexamethasone for patients with relapsed or refractory multiple myeloma.
On November 1, 2018, Amgen announced that new clinical data will be presented at the 60th ASH (Free ASH Whitepaper) annual meeting in December 2018 for Kyprolis and AMG-330.
Recent Acquisitions

Ligand announced the acquisition of Vernalis plc, a structure-based drug discovery biotechnology company with a broad pipeline of partnered programs and ongoing collaborations, for $43 million in cash, which was mostly offset by approximately $32 million of cash on hand at Vernalis after deal fees. The acquisition of Vernalis provides Ligand with more than eight fully-funded shots on goal, a 70-person R&D team based in Cambridge, England with a portfolio of ongoing collaboration agreements that have the potential to create additional shots on goal, a compound library of unpartnered programs for potential business development out-licensing and England-based operations that provide a platform to help efficiently pursue investment and acquisition activities in Europe and the United Kingdom.
Additional Pipeline and Partner Developments

Viking Therapeutics announced positive topline results from a 12-week Phase 2 study of VK2809 in patients with non-alcoholic fatty liver disease, which demonstrated statistically significant reductions in low-density lipoprotein cholesterol and statistically significant reductions in liver fat content, and that the study results would be presented in an oral late-breaker presentation at The Liver Meeting 2018.
Viking Therapeutics announced that results from its Phase 2 study of VK5211 in patients recovering from hip fracture were presented at the American Society for Bone and Mineral Research 2018 annual meeting.
Sage Therapeutics announced that the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted that data support the favorable benefit-risk profile of Zulresso injection for the treatment of postpartum depression (PPD).
Sage Therapeutics announced The Lancet published an integrated analysis across three double-blind, randomized, placebo-controlled studies of Zulresso injection in women with PPD, demonstrating significant and clinically meaningful reductions in HAM-D total score.
Melinta Therapeutics announced positive topline results from its Phase 3 trial of Baxdela for the treatment of adult patients with community-acquired bacterial pneumonia.
Retrophin announced presentation of new data examining the long-term effects of sparsentan in focal segmental glomerulosclerosis (FSGS) at the American Society of Nephrology Kidney Week 2018, and that the Journal of the American Society of Nephrology published online the positive results from Retrophin’s Phase 2 DUET study of sparsentan for the treatment of FSGS.
Retrophin announced two presentations related to sparsentan in the treatment of IgA Nephropathy during the 15th International Symposium on IgA Nephropathy.
Verona Pharma announced that it had enrolled the last patient in its Phase 2 clinical trial evaluating the effect of nebulized RPL554 as an add-on to dual therapy using long-acting anti-muscarinic / long-acting beta2-agonists and triple therapy in the maintenance treatment of patients with moderate to severe chronic obstructive pulmonary disease.
Aldeyra Therapeutics announced positive results from its Phase 2b clinical trial of topical ocular reproxalap in patients with dry eye disease demonstrating statistically significant reductions in the Four-Symptom Ocular Dryness Score and the Overall Ocular Discomfort Symptom Score.
Sermonix Pharmaceuticals announced the initiation of a 100-patient Phase 2 trial of oral lasofoxifene for the treatment of metastatic breast cancer.
Opthea Limited announced that its Phase 1b trial of OPT-302 in diabetic macular edema (DME) met its primary objective and that the company had dosed the first patient in a Phase 2a randomized, controlled clinical trial evaluating OPT-302 in patients with persistent center-involved DME.
Opthea Limited presented Phase 1/2a data of OPT-302 in wet age-related macular degeneration (AMD) at the Retina Society 2018 annual meeting.
Corvus Pharmaceuticals announced the publication of results of preclinical studies of CPI-444 demonstrating that it induces dose-dependent antitumor responses as a monotherapy and in combination with anti-PD-1, anti-PD-L1 and anti-CTLA-4 therapies.
Corvus Pharmaceuticals announced new data on a biomarker associated with patient response to therapy with CPI-444, an adenosine receptor antagonist at the European Society for Medical Oncology 2018 Congress.
OmniAb partner Arcus Biosciences announced that abstracts relating to its portfolio have been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.
Seelos Therapeutics announced a merger agreement with Apricus Biosciences, to form a combined publicly-traded company focused on developing a portfolio that includes Ligand-partnered CNS programs.
Roivant announced that OmniAb-derived RVT-1401 (previously HL161) will form the foundation of a new company called Immunovant.
Business Development

Ligand announced an OmniAb platform license agreement with the Fred Hutchinson Cancer Research Center (Fred Hutch) to use the OmniAb rodent platform technologies to discover fully human antibodies. Ligand is eligible to receive a defined share of revenue received by Fred Hutch from companies that commercialize products incorporating any such OmniAb-derived antibody.
Ligand entered into a Captisol use agreement with Sunshine Lake Pharma.
Adjusted Financial Measures

The Company reports adjusted net income and adjusted net income per diluted share in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company’s financial measures under GAAP include share-based compensation expense, amortization of debt-related costs, amortization related to acquisitions and intangible assets, changes in contingent liabilities, mark-to-market adjustments for amounts relating to our equity investments in Viking and Retrophin, unissued shares relating to the Senior Convertible Notes and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included at the end of this press release. However, other than with respect to total revenue, the Company only provides guidance on an adjusted basis and does not provide reconciliations of such forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in contingent liabilities, changes in the market value of our investments in Viking and Retrophin, share-based compensation expense and effects of any discrete income tax items. Management has excluded the effects of these items in its adjusted measures to assist investors in analyzing and assessing the Company’s past and future core operating performance. Additionally, adjusted earnings per diluted share is a key component of the financial metrics utilized by the Company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

Conference Call

Ligand management will host a conference call today beginning at 9:00 a.m. Eastern time (6:00 a.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (833) 591-4752 from the U.S. or (720) 405-1612 from outside the U.S., using the conference ID 5777841. To participate via live or replay webcast, a link is available at www.ligand.com.

On November 8, 2018 Scholar Rock Holding Corporation (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported financial results for the third quarter ended September 30, 2018 and highlighted recent progress and upcoming milestones for its pipeline programs (Filing, 8-K, Scholar Rock, NOV 8, 2018, View Source [SID1234530987]).

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"We continue to make important progress with our pipeline having now completed enrollment in the multiple ascending dose portion of the ongoing Phase 1 clinical trial for SRK-015 with interim results and the initiation of a Phase 2 proof-of-concept study in patients with Spinal Muscular Atrophy (SMA) expected in the first quarter of 2019," said Nagesh Mahanthappa, Ph.D, President and CEO of Scholar Rock. "We also look forward to our upcoming presentation of preclinical data at the SITC (Free SITC Whitepaper) annual meeting that will demonstrate the ability of a highly specific inhibitor of TGFβ1 to render resistant solid tumors vulnerable to anti-PD1 while minimizing the toxicities traditionally associated with pan-TGFβ inhibitors."

Key R&D Highlights and Upcoming Milestones

SRK-015 Program:

Completed Enrollment in Multiple Ascending Dose Portion of Phase 1 Clinical Trial for SRK-015 with Interim Results Expected the First Quarter of 2019. A placebo-controlled, double-blind Phase 1 clinical trial was initiated in May 2018 to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of intravenous SRK-015, a selective inhibitor of the activation of myostatin, in healthy adult volunteers. Enrollment in the single ascending dose and multiple ascending dose portions of the trial have been completed. Interim results from this ongoing Phase 1 trial are expected in the first quarter of 2019.
Plan to Initiate Phase 2 Proof-of-Concept Study for SRK-015 in SMA in the First Quarter of 2019. Pending supportive safety data from the Phase 1 clinical trial, Scholar Rock plans to initiate a Phase 2 proof-of-concept study in the first quarter of 2019 to evaluate the safety and efficacy of SRK-015 in patients with SMA as a monotherapy or in conjunction with an approved survival motor neuron (SMN) upregulator therapy as background standard of care.
Plan to Identify Second Indication for SRK-015 in the First Half of 2019. Scholar Rock is actively assessing numerous potential clinical settings in which the selective inhibition of the activation of myostatin may offer therapeutic benefit and intends to identify a second indication for SRK-015 in the first half of 2019.
TGFβ1 Program:

Presenting Preclinical Data at Upcoming SITC (Free SITC Whitepaper) Annual Meeting Highlighting the Role of TGFβ1 Inhibition in Overcoming Primary Resistance to Anti-PD1. At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting being held November 9-11, 2018, Scholar Rock will be presenting preclinical results demonstrating the ability of a highly specific inhibitor of TGFβ1, SRTβ1-Ab3, to render tumors vulnerable to checkpoint blockade therapy in syngeneic tumor models of primary resistance (Poster #550). Combination treatment with SRTβ1-Ab3 and anti-PD1 resulted in tumor regression or tumor control, and a significant survival benefit, while minimizing toxicities traditionally associated with pan-TGFβ inhibitors.
Plan to Nominate Product Candidate for TGFβ1 Program by the End of the First Half of 2019. Scholar Rock’s second antibody program is focused on the development of highly specific inhibitors of the activation of TGFβ1, and the company intends to nominate a product candidate and first indication in oncology, immuno-oncology or fibrosis by the end of the first half of 2019.
Third Quarter 2018 Financial Results

Net loss for the quarter ended September 30, 2018 was $10.8 million or $0.44 per share compared to a net loss of $5.9 million or $3.70 per unit for the same quarter last year.

Research and development expense was $8.1 million for the quarter ended September 30, 2018, compared to $4.8 million in the same quarter in 2017. The $3.3 million increase year-over-year reflects development and manufacturing costs associated with lead product candidate, SRK-015, research costs associated with preclinical studies, as well as increased personnel-related costs to support continued progress with the pipeline.
General and administrative expense was $3.2 million for the quarter ended September 30, 2018, compared to $1.2 million in the same quarter in 2017. The $2.0 million increase year-over-year was primarily attributable to increased headcount and higher professional and consulting fees associated with ongoing business activities and operating as a public company.
As of September 30, 2018, Scholar Rock had cash, cash equivalents, and marketable securities of $104.0 million, compared to $58.0 million at the end of 2017. Scholar Rock believes its cash and cash equivalents balance will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2020.

On November 8, 2018 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 2018.

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Recent Commercial Achievements:

Intrexon continues discussions with several major energy companies concerning partnering of its Methane Bioconversion Platform;
Site selection on Intrexon’s first 2,3 BDO plant is on track for year end;
Okanagan Specialty Fruits, a wholly owned subsidiary of Intrexon, completed the 2018 Arctic Apple harvest, yielding ten times last year’s production, and expects to make pre-sliced Arctic apples available through over 500 retail outlets this month;
EnviroFlight, Intrexon’s joint venture with Darling Ingredients Inc., is scheduled to open phase one of the largest black soldier fly larvae (BSFL) facility in the U.S. this month; and
Intrexon commenced deployment of its Botticelli platform, beginning with a collaboration in tomato with a large international producer.
Recent Technical/Business Achievements:

Precigen, Inc., a wholly owned subsidiary of Intrexon, recently reported data on a multigenic therapeutic candidate that in appropriate pre-clinical models suggests potential superiority to approved anti-PD-1 checkpoint inhibitors;
From Intrexon’s methane bioconversion platform, the Company now is producing 2,3, BDO from natural gas at roughly 50% of the theoretical target yield, has demonstrated performance at 500X scale-up and has conducted sustained production runs exceeding 1,000 hours;
Oxitec, Ltd., a wholly owned subsidiary of Intrexon, entered into a second cooperative agreement with the Bill & Melinda Gates Foundation to develop a new strain of Oxitec’s Friendly biological engineering platform to develop a self-limiting Anopheles stephensi mosquito to help combat this mosquito that spreads malaria in India, Middle East and the Horn of Africa;
ActoBio Therapeutics, Inc., a wholly owned subsidiary of Intrexon, and T1D Partners, LLC, announced that the first patient has been dosed in the Company’s Phase Ib/IIa clinical trial for AG019 for the treatment of early onset type 1 diabetes (T1D);
Continuing its expansion into regenerative medicine, Exemplar Genetics, a wholly owned subsidiary of Intrexon, reported the first pig has been born with the potential to produce organs for human transplant;
Trans Ova Genetics, a wholly owned subsidiary of Intrexon, created six bull calves that rank at the top of the global Holstein bull population;
Intrexon announced advances in the development of its engineered yeast platform to produce cannabinoids for medical use via fermentation. This microbe-based process has potential to provide greater supply-chain security and avoids the resource-intensive isolation that often leads to quality and quantity variability in end products;
The U.S. Food and Drug Administration (FDA) recommended amendment of the Association of American Feed Control Officials (AAFCO) ingredient definition of dried BSFL to include feeding to poultry. The approval of BSFL for use in poultry feed expands the potential for this ingredient as a more sustainable source of protein and enables EnviroFlight to support this new market opportunity with its new facility;
Collaborator Fibrocell Science, Inc. (NASDAQ: FCSC) reported the FDA granted Fast Track Designation to FCX-013, the company’s clinical stage candidate for the treatment of moderate to severe localized scleroderma, and the FDA’s Office of Orphan Products Development awarded Fibrocell a $1.4 million clinical trial research grant for continued clinical development of FCX-007, the company’s gene therapy candidate for the treatment of recessive dystrophic epidermolysis bullosa (RDEB); and
Collaborator Oragenics, Inc. (NYSE: OGEN) announced the resumption of its Phase 2 clinical trial for AG013 for the potential treatment of oral mucositis (OM).
Recent Corporate Highlights:

Intrexon completed its registered underwritten public offering of $200 million aggregate principal amount of 3.50% convertible senior notes due in 2023 (Convertible Notes);
Precigen Inc., a wholly owned subsidiary of Intrexon, and Ziopharm Oncology, Inc. (NASDAQ: ZIOP) announced a new definitive license agreement to replace all existing agreements between the companies that will provide Ziopharm exclusive and non-exclusive rights to technology controlled by Precigen, Inc., as well as securing for Precigen developmental control over the majority of its portfolio.
The Company, through its subsidiary ActoBio Therapeutics, acquired the remaining interests in certain entities previously owned by a related party. As a result, ActoBio owns the exclusive rights to use its technologies to develop therapeutics in the fields of chronic rhinosinusitis and celiac disease;
Intrexon transferred its stock exchange listing from the New York Stock Exchange (NYSE) to the Nasdaq Global Select Market (Nasdaq) and began trading under "XON" ticker on the Nasdaq exchange on September 25, 2018; and
Intrexon announced the formation of a Bioinformatics Hub in Munich, establishing Intrexon Bioinformatics Germany GmbH (IBG).
Third Quarter 2018 Financial Highlights:

Total revenues of $32.4 million, a decrease of 30% from the third quarter of 2017;
Net loss of $57.3 million attributable to Intrexon, or $(0.44) per basic share, including non-cash charges of $38.7 million;
Adjusted EBITDA of $(28.9) million, or $(0.22) 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 $17.3 million compared to a decrease of $8.6 million in the third quarter of 2017; and
Cash, cash equivalents, and short-term investments totaled $246.6 million, the value of preferred shares totaled $158.4 million, and the value of common equity securities totaled $4.7 million at September 30, 2018.
Year-to-Date 2018 Financial Highlights:

Total revenues of $117.4 million, a decrease of 24% from the nine months ended September 30, 2017;
Net loss of $168.9 million attributable to Intrexon, or $(1.31) per basic share, including non-cash charges of $109.0 million;
Adjusted EBITDA of $(75.3) million, or $(0.58) per basic share; and
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 $34.5 million compared to a decrease of $28.2 million in the nine months ended September 30, 2017.
"Our company is transitioning from one with great science and technology to one with great products and product candidates that embody our engineered biology," commented Randal J. Kirk, Chairman and Chief Executive Officer of Intrexon. "Recognizing our requirements, we are fully occupied on the development of systems, teams and plans to successfully commercialize products that we believe will be transformative in their fields."

Mr. Kirk concluded, "While we do not underestimate the challenges that face us – or anyone – in making such a transition, we have persevered in the execution of our plans laid long ago and believe that we are seeing the fruits of our prior labors. It long has been our goal to create one of the truly great companies in the world and all of us at intrexon are excited to be where we are today and looking with great anticipation toward our future."

Third Quarter 2018 Financial Results Compared to Prior Year Period

Total revenues decreased $13.6 million, or 30%, from the quarter ended September 30, 2017. Collaboration and licensing revenues decreased $13.8 million from the quarter ended September 30, 2017 due to (i) a 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, (ii) a decrease in research and development services for certain of the Company’s ECCs as a result of program progression where the Company’s collaborators have taken responsibility of the execution of the programs, (iii) changes in revenue recognition for upfront and milestone payments under the new Accounting Standards Codification 606, or ASC 606, revenue standard whereby revenues are recognized based on the amount of services the Company performs for its collaborators, and (iv) the mutual termination of the Company’s second ECC with ZIOPHARM for the treatment of graft-versus-host disease in December 2017. Gross margin on products declined in the current period as a result of increased operating costs associated with new product offerings and cloned products. Gross margin on services improved in the current period as a result of pricing changes and an increase in the number of embryos produced per bovine in vitro fertilization cycle due to improved production results.

Research and development expenses increased $8.4 million, or 23%, and include $8.7 million expense related to in-process research and development reacquired as part of an asset acquisition in September 2018. Although selling, general and administrative (SG&A) expenses were consistent period over period, legal and professional fees decreased $2.9 million primarily due to a decline in the use of regulatory and other consultants. This decrease was offset primarily by higher compensation expenses related to performance and retention incentives for SG&A employees.

Year-to-Date 2018 Financial Results Compared to Prior Year Period

Total revenues decreased $36.6 million, or 24%, from the nine months ended September 30, 2017. Collaboration and licensing revenues decreased $37.8 million from the nine months ended September 30, 2017 primarily due to (i) a decrease in research and development services for certain of the Company’s 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, (ii) a decrease in research and development services for certain of the Company’s ECCs as a result of program progression where the Company’s collaborators have taken responsibility of the execution of the programs, (iii) changes in revenue recognition for upfront and milestone payments under the new ASC 606 revenue standard whereby revenues are recognized based on the amount of services the Company performs for its collaborators, and (iv) the mutual termination of the Company’s second ECC with ZIOPHARM for the treatment of graft-versus-host disease in December 2017. Product revenues decreased $2.2 million or 9% primarily due to lower customer demand for live calves, cows previously used in production, and cloned products. These decreases were partially offset by increased customer demand for pregnant recipients. Gross margin on products declined in the current period as a result of lower product sales and increased operating costs associated with new product offerings and cloned products. The increase in service revenues of $2.5 million, or 7%, as well as the gross margin thereon relates to pricing changes and an increase in the number of embryos produced per bovine in vitro fertilization cycle due to improved production results.

Research and development expenses increased $19.4 million, or 19%, and include (i) $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 Brazilian subsidiary’s leased research and development facilities as the Company decentralized operations previously conducted in this facility. Research and development consultants and lab supplies increased $3.1 million primarily due to increased expenses from contract research organizations and consultants providing services for both programs being developed internally and pursuant to some of the Company’s collaborations. Depreciation and amortization increased $2.1 million primarily as a result of the depreciation expense on research and development assets and amortization of developed technology acquired from GenVec, Inc. in June 2017. Although SG&A expenses were consistent period over period, legal and professional fees decreased $7.5 million primarily due to decreased legal fees associated with ongoing litigation and decreased fees incurred for regulatory and other consultants. This decrease was offset by an increase of $6.9 million in compensation expenses related to performance and retention incentives for SG&A employees.

Conference Call and Webcast

The Company will host a conference call today Thursday, November 8th, at 5:30 PM ET to discuss the third 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 8225818 to join the Intrexon Corporation Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source

On November 8, 2018 Innovus Pharmaceuticals, Inc., ("Innovus Pharma") (OTCQB: INNV), reported that the Company will release its September 30, 2018 third quarter financial results on Wednesday, November 14, 2018, after the close of the U.S. financial markets (Press release, Innovus Pharmaceuticals, NOV 8, 2018, http://client.irwebkit.com/innovuspharma/news/2442530 [SID1234531036]). The Company will host a conference call at 4:15 p.m. ET/1:15 p.m. PT on the same day to discuss the financial results and recent business developments.

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