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CombiMatrix Corporation Reports First Quarter 2016 Financial and Operating Results

On May 04, 2016 CombiMatrix Corporation (NASDAQ:CBMX), a molecular diagnostics company specializing in DNA-based testing services for pre-implantation genetic diagnostics and screening, miscarriage analysis, prenatal and pediatric diagnostics, reported financial results for the three months ended March 31, 2016 (Press release, CombiMatrix, MAY 4, 2016, View Source [SID:1234511927]).

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"We are reporting another exceptional quarter of financial progress, with 28% revenue growth, expanded gross margin, increased cash collections and well managed operating expenses," said Mark McDonough, CombiMatrix President and CEO. "Our growth was driven by a 39% increase in reproductive health revenue on an 18% increase in test volume, reflecting higher average revenue per test. We are particularly pleased with our performance in miscarriage analysis testing, with revenues up 43% on 13% test volume growth. We also benefited from better productivity from our newer sales representatives, which contributed to an 18% increase in our customer base.

"We anticipate that various industry dynamics will favorably impact our business," he added. "In March, the two leading associations in women’s healthcare, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM), issued revised practice bulletins recommending that all women regardless of age or other risk factors are offered prenatal genetic testing. These bulletins reiterated the need to perform confirmatory testing when screening tests reveal positive results for fetal abnormalities. Additionally, a number of health plans, including Cigna and several in the Blue Cross Blue Shield network, have recently revised their medical policies to cover chromosomal microarray testing for recurrent pregnancy loss. We believe that more health plans will follow suit based on the growing clinical support for this valuable patient information.

"We are firmly focused on growth and a path toward profitability, supported by tight execution of our business strategy," said Mr. McDonough. "This year we plan to expand our IVF testing portfolio and expect to increase physician adoption through more clinical validation, improved marketing developed from the insights from our newly appointed Scientific Advisory Board, and greater productivity from our sales organization. We also are seeking opportunities to build upon our leadership position in the growing reproductive health diagnostics market and enhance shareholder value through partnerships and other business development alternatives. With the completion of an $8 million financing in late March, we are well positioned to execute on our plans."

First Quarter Financial and Operational Highlights (all comparisons are with the first quarter of 2015)

Total revenues of $3.0 million, up 28%
Reproductive health revenues of $2.2 million, up 39%
Reproductive health test volume of 1,426, up 18%
Number of billable customers reaches 264, up 18%
Cash collections of $2.5 million, up 15%
Closed $8.0 million underwritten public offering in March of 2016
Launched CombiPGD – Preimplantation Genetic Diagnosis for Single Gene Disorders and Chromosomal Translocations
Formed Scientific Advisory Board

Volumes
Revenues (in 000’s)
Q1 ’16 Q1 ’15 # Δ % Δ Q1 ’16 Q1 ’15 $ Δ % Δ
Prenatal 264 324 (60 ) (19 %) $ 321 $ 422 $ (101 ) (24 %)
Miscarriage analysis 995 882 113 13 % 1,622 1,132 490 43 %
PGS 167 - 167 - 222 - 222 -
Subtotal – reproductive health 1,426 1,206 220 18 % 2,165 1,554 611 39 %
Pediatric 452 467 (15 ) (3 %) 500 497 3 1 %
Subtotal – all arrays 1,878 1,673 205 12 % 2,665 2,051 614 30 %
Non-array tests 770 672 98 15 % 265 236 29 12 %
Total – all tests 2,648 2,345 303 13 % 2,930 2,287 643 28 %
Royalties 42 42 - 0 %
Total revenues $ 2,972 $ 2,329 $ 643 28 %

Financial Results

Total revenues for the first quarter of 2016 increased 28% to $3.0 million from $2.3 million for the first quarter of 2015. Revenues for the first quarter of 2016 were comprised of $2.9 million of diagnostic services revenue and $42,000 in royalties. Reproductive health diagnostic test revenue, which includes prenatal microarrays, miscarriage analysis and PGS, increased 39% to $2.2 million and related testing volumes increased 18% to 1,426. The first quarter 2016 revenue increase was driven partially by higher test volumes, particularly from miscarriage analysis and PGS testing, but primarily by higher average revenue per test in miscarriage analysis testing.

Total operating expenses were $4.4 million for the first quarter of 2016, compared with $4.1 million for the first quarter of 2015. The increase was due primarily to an increase in cost of services related to higher test volumes and from an increase in sales and marketing expenses related to sales force expansion. Gross margins for the first quarter of 2016 improved to 51.6% from 46.2% for the first quarter of 2015 due primarily to improved average reimbursement on miscarriage analysis testing.

The net loss for the first quarter of 2016 was $1.5 million, or $1.73 per share, compared with a net loss for the first quarter of 2015 of $1.8 million, or $2.24 per share. Net loss attributable to common stockholders for the first quarter of 2016 was $3.1 million, or $3.63 per share, compared with a net loss attributable to common stockholders for the first quarter of 2015 of $2.7 million, or $3.37 per share. The higher net loss attributable to common stockholders in 2016 reflected one-time, non-cash charges of $1.9 million related to deemed dividends from the issuance of Series F convertible preferred stock and warrants in the $8.0 million public offering that closed on March 24, 2016. This increase was partially offset by the reversal of the $890,000 Series E deemed dividend recognized in 2015 from the repurchase of those securities upon closing of our public offering, partially reduced by the $656,000 deemed dividend paid to the Series E investors in February of 2016.

The Company reported $6.6 million in cash, cash equivalents and short-term investments as of March 31, 2016, compared with $3.9 million as of December 31, 2015. The Company used $1.7 million in cash to fund operating activities during the first quarter of 2016, compared with $1.2 million to fund operating activities during the comparable period in 2015. The increase in net cash used to fund operating activities in 2016 resulted primarily from the timing of the purchase of inventory supplies, coupled with higher overall headcount in early 2016 compared with 2015.

bluebird bio Reports First Quarter 2016 Financial Results and Recent Operational Progress

On May 4, 2016 bluebird bio, Inc. (Nasdaq: BLUE) a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, reported business highlights and financial results for the first quarter ended March 31, 2016 (Press release, bluebird bio, MAY 4, 2016, View Source;p=RssLanding&cat=news&id=2165083 [SID:1234511925]).

"In early 2016 we achieved two crucial clinical milestones: treating the first patient in the Phase 1 study of our anti-BMCA CAR T therapy bb2121, and presenting the first clinical data from our Starbeam study of Lenti-D in boys with CALD. We are very pleased with this significant progress as we continue to build our T cell immunotherapy and HSC gene therapy platforms," said Nick Leschly, chief bluebird. "On the LentiGlobinTM program, we are on track to achieve our remaining milestones this year, which include initiation of the HGB-207 study in non-ß0/ß0 transfusion-dependent thalassemia (TDT) as well as integration of manufacturing process improvements into our LentiGlobin clinical trials."

Recent Highlights

PRESENTED INTERIM DATA FROM STARBEAM STUDY AT AAN – In April, Dr. Florian Eichler of Massachusetts General Hospital for Children presented interim clinical data from the Starbeam study of Lenti-D in CALD at AAN. Initial Starbeam results suggest Lenti-D gene therapy may have similar efficacy to allogeneic hematopoietic stem cell transplant (HCT), the current standard of care, with a more favorable safety profile. As of March 31, 2016, three of the 17 patients enrolled in the study have reached two years of follow-up and remain free of major functional disabilities (MFDs), the primary endpoint of the study. Sixteen of the 17 patients had stabilization of their neurological function score (NFS), and 14 of 17 had a stable Loes score. The safety profile of Lenti-D treatment appeared consistent with myeloablative conditioning.

TEN ABSTRACTS ACCEPTED FOR PRESENTATION AT ASGCT (Free ASGCT Whitepaper) 19th ANNUAL MEETING – Two oral presentations given by bluebird’s academic collaborators will highlight previously presented data from bluebird bio’s ongoing gene therapy clinical trials, including interim data from the Starbeam Study of Lenti-D in cerebral adrenoleukodystrophy, and interim data from the HGB-205 study of LentiGlobin in severe sickle cell disease and TDT. Eight additional presentations will be featured at the meeting, highlighting progress across the company’s preclinical, research and process development activities in both HSC gene therapy and T cell immunotherapy.

TREATED FIRST PATIENT IN PHASE 1 STUDY OF BB2121 IN MULTIPLE MYELOMA – In February, the first patient was infused in the CRB-401 study of anti-BCMA CAR T therapy bb2121 in relapsed/refractory multiple myeloma. Additionally, Celgene exercised its option to exclusively license bb2121. Under the terms of the collaboration agreement between the two companies, bluebird bio received a $10.0 million option exercise payment from Celgene and may now elect to co-develop and co-promote the product candidate in the United States with Celgene. We are also eligible to receive specified development and regulatory milestone payments and royalty payments on net sales.

FULLY ENROLLED EXPANDED NORTHSTAR STUDY – Achievement of 18 patient enrollment target in Northstar Study of LentiGlobin in patients with transfusion-dependent thalassemia, including three additional adolescent patients.
Upcoming Anticipated Milestones

Update on LentiGlobin process improvements in the second half of 2016
Initiation of the HGB-207 study in patients with TDT with the non-ß0/ß0 genotype in the second half of 2016
Presentation of updated clinical data for LentiGlobin at the ASH (Free ASH Whitepaper) annual meeting in December 2016
First Quarter 2016 Financial Results and Financial Guidance

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2016 were $826.9 million, compared to $865.8 million as of December 31, 2015, a decrease of $38.9 million.
Revenues: Collaboration revenue was $1.5 million for the first quarter of 2016 compared to $6.3 million for first quarter of 2015. The decrease is a result of an amendment to our collaboration agreement with Celgene in the second quarter of 2015.
R&D Expenses: Research and development expenses were $41.9 million for the first quarter of 2016 compared to $23.7 million for the first quarter of 2015. The increase in research and development expenses was primarily attributable to increased employee compensation and facilities costs due to increased headcount, and increased manufacturing, clinical, research, and information technology costs to support the advancement of our clinical and pre-clinical programs.
G&A Expenses: General and administrative expenses were $16.0 million for the first quarter of 2016 compared to $7.3 million for the first quarter of 2015. The increase in general and administrative expenses was primarily attributable to increased employee compensation expense due to increased headcount, and consulting costs to support our overall growth.
Net Loss: Net loss was $56.3 million for the first quarter of 2016 compared to $24.8 million for the first quarter of 2015.
Financial guidance: bluebird bio expects that its cash, cash equivalents and marketable securities of $826.9 million as of March 31, 2016 will be sufficient to fund its current operations through 2018.

Ionis Reports Financial Results and Highlights for First Quarter 2016

On May 4, 2016 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) reported its financial results for the first quarter were in line with the company’s expectations (Press release, Ionis Pharmaceuticals, MAY 4, 2016, View Source;p=RssLanding&cat=news&id=2164982 [SID:1234511917]).

"2016 is off to a strong start. Target enrollment is complete in four Phase 3 studies across nusinersen, IONIS-TTRRx and volanesorsen. These important new drugs are now one step closer to potentially reaching the market and being available to patients. We are actively engaged in NDA preparations for all three of these drugs in anticipation of Phase 3 data from each in the first half of next year," said B. Lynne Parshall, chief operating officer of Ionis Pharmaceuticals. "We are pleased to have chosen a new commercial partner for Kynamro. We believe Kastle Therapeutics has the rare disease expertise, financial resources and initiative to expand the market potential for Kynamro. Already Kastle has begun to identify new patients to bring onto Kynamro therapy in the United States, and it is initiating activities to pursue marketing approval in other countries."

"Just last month at the AAN meeting, we provided an update on our Phase 2 open-label study with a data cut-off of January 26, 2016 in infants with SMA treated with nusinersen. The infants in this study are continuing to improve. At the AAN meeting, we reported that we had no deaths or events of permanent ventilation since late 2014. All of the continuing infants are over two years old and several have passed their third birthday. We are especially encouraged by continued improvements in motor function in these infants, as evidenced by both continued increases in muscle function scores and achievement of developmental milestones that infants with Type 1 SMA are never expected to achieve, including sitting, standing and even walking. These data give us further confidence in our two Phase 3 studies in infants and children with SMA, from which we expect to have data in the first half of 2017. We continue to work closely with our partner, Biogen, who is preparing to bring this drug to the market for infants and children with SMA," continued Ms. Parshall.

"Also at the AAN meeting, we and our collaborators presented more than a dozen presentations and posters highlighting our broad neurological disease pipeline, which is focused on treating diseases that have been largely untreatable using other therapeutic modalities. Over the last several years, we have substantially expanded the reach of our technology to address a large number of disease targets in the central nervous system," said Ms. Parshall. "We continue to increase the value of our pipeline and technology by expanding the use of our antisense technology into new disease areas, new targets, new tissues and new mechanisms. We hope that you will join us in July for our R&D day during which we will be discussing our broad, innovative pipeline and the groundbreaking work we are doing to continue to broaden the application of our technology," concluded Ms. Parshall.

Financial Results

"We finished the first quarter of 2016 with a pro forma net operating loss of $35 million and more than $700 million in cash. On a GAAP basis, our operating loss was $55 million. In the first quarter, we earned $37 million of revenue including more than $15 million in milestone payments, the majority of which were related to the progression of our Phase 3 program for nusinersen. As nusinersen and our other partnered programs advance, we have the opportunity to earn significant revenue this year. We are eligible to earn up to $95 million in upfront and milestone payments from Kastle, $15 million of which we will recognize in the second quarter. We will receive a ten percent common equity position in Kastle’s parent company. Starting in 2017, we are also entitled to royalties that average in the mid to low teens on global sales of Kynamro. Additionally, our financial projections include numerous significant milestone payments in the second half of this year, including a $55 million milestone payment from Bayer related to advancing IONIS-FXIRx, compared to 2015 when our revenue was more evenly spread throughout the year. We also have the opportunity to earn a $25 million milestone payment for advancing the first drug under our cardiometabolic collaboration with AstraZeneca and a $10 million milestone payment for advancing the first drug under our J&J collaboration. We also have numerous opportunities during the remainder of 2016 to earn meaningful milestone payments as we advance research programs and drugs under our Biogen collaborations," said Elizabeth L. Hougen, chief financial officer of Ionis Pharmaceuticals.

"Our pro forma operating expenses for the first quarter were $71 million, a significant portion of which were associated with the five Phase 3 studies and three open-label extension studies related to these Phase 3 studies, we are conducting. In addition, Akcea continues to build its infrastructure and conduct the pre-commercialization activities necessary to launch volanesorsen. We are doing all of this while managing our expenses prudently. On a GAAP basis, our operating expenses were $92 million," continued Ms. Hougen.

"Our first quarter financial results were in line with our expectations and we are on track to meet our 2016 guidance of a pro forma NOL in the low $60 million range and a year-end cash balance in excess of $600 million," concluded Ms. Hougen.

All pro forma amounts referred to in this press release exclude non-cash compensation expense related to equity awards. Please refer to the reconciliation of pro forma and GAAP measures, which is provided later in this release.

Revenue

Ionis’ revenue for the three months ended March 31, 2016 was $36.9 million, compared to $62.6 million for the same period in 2015. Ionis’ revenue in the first quarter of 2016 included the following:

$12.5 million from Biogen for advancing the Phase 3 program for nusinersen and advancing IONIS-BIIB4Rx;
$1.5 million from GSK for advancing IONIS-HBV-LRx; and
$22.9 million primarily from the amortization of upfront fees and manufacturing services Ionis performed for its partners.
Ionis’ revenue fluctuates based on the nature and timing of payments under agreements with its partners and consists primarily of revenue from the amortization of upfront fees, milestone payments and license fees. The Company’s financial projections include numerous significant milestone payments in the second half or this year, compared to 2015 when its revenue was more evenly spread throughout the year.

Operating Expenses
Ionis’ operating expenses included costs to support the Company’s ongoing Phase 3 studies for nusinersen, IONIS-TTRRx and volanesorsen. In addition, Akcea continued to build its operations in preparation for the commercial launch of volanesorsen. As such, Ionis’ pro forma operating expenses were $71.4 million for the three months ended March 31, 2016, and increased compared to $58.6 million for the same period in 2015. On a GAAP basis, Ionis’ operating expenses for the three months ended March 31, 2016 were $91.5 million, compared to $71.9 million for the same period in 2015. Ionis’ operating expenses on a GAAP basis included non-cash compensation expense related to equity awards, which increased because the average fair value of unvested stock options has risen due to the increase in the exercise price of the stock options the Company has granted over the past several years.

Net Loss
Ionis reported a net loss of $62.9 million for the three months ended March 31, 2016, compared to a net loss of $16.7 million for the same period in 2015. Basic and diluted net loss per share for the three months ended March 31, 2016 was $0.52 compared to $0.14 for the same period in 2015. Ionis’ net loss increased for the three months ended March 31, 2016 compared to the same period in 2015 primarily due to variations in the timing of revenue from milestone payments and to a lesser extent, an increase in operating expenses primarily associated with the Company’s Phase 3 studies.

Balance Sheet
As of March 31, 2016, Ionis had cash, cash equivalents and short-term investments of $703.8 million compared to $779.2 million at December 31, 2015. Ionis’ cash balance decreased in 2016 primarily due to spending to support the Company’s ongoing Phase 3 programs for nusinersen, IONIS-TTRRx and volanesorsen. Ionis’ working capital was $639.4 million at March 31, 2016 compared to $688.1 million at December 31, 2015.

Inovio Pharmaceuticals Showcases its Broad Pipeline of DNA-based Immunotherapies, Vaccines and dMAbs at the American Society of Gene & Cell Therapy

On May 04, 2016 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported it will exhibit the breadth and promise of its cancer and infectious disease immunotherapy, vaccine and DNA-based monoclonal antibody (dMAb) pipeline in 10 presentations at the 19th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) held in Washington, DC from May 4-7 (Press release, Inovio, MAY 4, 2016, View Source;Cell-Therapy/default.aspx [SID:1234511916]).

The ASGCT (Free ASGCT Whitepaper) abstract review committee selected Inovio’s presentation of its successful preclinical Ebola vaccine development for one of only three presentations to be given at its prestigious Presidential Symposium. In the selected abstract, out of 768 submitted and accepted, the presented preclinical testing in mice and non-human primates showed Inovio’s Ebola vaccine protected 100% of immunized animals from sickness and death following exposure to a lethal dose of Ebola virus. Those results led to a study of 75 healthy subjects which showed the vaccine was safe, tolerable, and generated strong T cell and antibody responses in human as well.

Inovio’s Ebola results will be offered on Friday, May 6, at 2:50 p.m. in a presentation entitled: "479 – An Optimized DNA Vaccine Formulation Protects Against Lethal Ebola Makona Virus Challenge in Non-Human Primates and Elicits Robust Immune Responses."

Dr. J. Joseph Kim, President and CEO, said, "The results we will present at the ASGCT (Free ASGCT Whitepaper) global scientific forum demonstrate the potential and breadth of the three pillars of Inovio’s broad pipeline: Immunotherapies and vaccines against cancers and challenging infectious diseases and our DNA-encoded monoclonal antibodies (dMAbs), which we believe will offer clear advantages over conventional monoclonal antibody technologies including faster development, easier product manufacturing, and more favorable pharmacokinetics."

Inovio and its collaborators will present clinical and preclinical data that supports its on-going trials exploring the next generation of immunotherapies, vaccine and monoclonal antibodies at the following times over the next two days (link to abstracts):

19th Annual Meeting of the American Society of Gene & Cell Therapy

May 5

264 – In Vivo DNA-Monoclonal Antibody (DMAb) Gene Delivery Protects Against Lethal Bacterial and Viral Challenges in Mice
5:30 – 5:45 p.m.

428 – Generation of DNA Plasmid-Encoded Neutralizing Monoclonal Antibodies In Vivo
6:00 – 8:00 p.m.

433 – DNA Monoclonal Antibodies Target Influenza Virus In Vivo
6:00 – 8:00 p.m.

435 – Skin Delivery of a RSV Vaccine with Surface Electroporation Provides Full Protection from Lower Respiratory Disease in the Cotton Rat
6:00 – 8:00 p.m.

436 – Developing a Synthetic DNA Vaccine for an Emerging Pathogen – Middle East Respiratory Syndrome
6:00 – 8:00 p.m.

440 – Extreme Polyvalency Induces Potent Cross-Clade Cellular and Humoral Responses in Rabbits and Non-Human Primates
6:00 – 8:00 p.m.

401 – In Vivo Expression of Plasmid Encoded IgG for PD-1 or LAG3 by Synthetic DNA as a New Tool for Cancer Immunotherapy
6:00 – 8:00 p.m.

May 6

479 – An Optimized DNA Vaccine Formulation Protects Against Lethal Ebola Makona Virus Challenge in Non-Human Primates and Elicits Robust Immune Responses
2:50 – 3:10 p.m.

505 – VGX-3100 Drives Regression of HPV16/18 CIN2/3 and Robust Cellular Immune Responses in Blood and Cervical Tissue in a Blinded, Randomized, Placebo-Controlled Phase 2B Study
4:00 – 4:15 p.m.

643 – Various Forms of CD40L Encoded as an Immune Plasmid Adjuvant Generate Unique Anti-Cancer DNA Vaccine Induced Responses
6:00 – 8:00 p.m.

About the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper)

ASGCT is the primary professional membership organization for gene and cell therapy. The Society’s members are scientists, physicians, patient advocates, and other professionals. Its members work in a wide range of settings including universities, hospitals, government agencies, foundations, biotechnology and pharmaceutical companies. Its mission is to advance knowledge, awareness, and education leading to the discovery and clinical application of gene and cell therapies to alleviate human disease.

8-K – Current report

On MAY 4, 2016 GlycoMimetics, Inc. (NASDAQ: GLYC) reported financial results for the first quarter ended March 31, 2016.
"In February of 2016, we announced the topline readout of data from the first two cohorts in our ongoing Phase 1/2 clinical trial evaluating our drug candidate GMI-1271 in relapsed/refractory acute myeloid leukemia (AML) patients (Filing, Q1, GlycoMimetics, 2016, MAY 4, 2016, View Source [SID:1234511914]). Of the first 13 evaluable patients dosed with GMI-1271 in combination with chemotherapy, investigators observed clinical responses in eight patients, for an overall response rate of 62 percent. This group of 13 patients also tolerated GMI-1271 well. This is an important finding, and it is our plan to present the data in greater detail at a major medical meeting," said Rachel King, GlycoMimetics’ Chief Executive Officer. "In addition, we plan soon to initiate clinical development of GMI-1359, our third product candidate, also with a novel mechanism of action targeting E-selectin and CXCR4, an important target believed to play a key role in cancer cell migration and infiltration. Here our initial indications will likely also be hematological cancers, but in the future we may expand into solid tumors as well. We anticipate filing an investigational new drug application (IND) with the U.S. Food & Drug Administration for GMI-1359 in the third quarter of 2016."

As of March 31, 2016, GlycoMimetics had cash and cash equivalents of $38.8 million. GlycoMimetics reported no revenue for the quarter ended March 31, 2016 or the quarter ended March 31, 2015. The company’s research and development expenses increased to $5.5 million for the quarter ended March 31, 2016 as compared to $5.2 million for the first quarter of 2015. During the three months ended March 31, 2016, our research and development expense increased by approximately $300,000 compared to the same period in 2015, an increase of 6 percent that was primarily attributable to an increase in GMI-1271 clinical trial costs, offset in part by a decrease in expenses related to manufacturing and process development for GMI-1271. In addition, the preclinical development of GMI-1359 has resulted in increased expenses in manufacturing and for toxicology studies required to support a potential IND filing. The company’s general and administrative expenses increased slightly to $2.1 million for the quarter ended March 31, 2016 as compared to $1.9 million for the first quarter of 2015. These increases were primarily due to increased headcount and associated salaries and stock-based compensation expense.