On May 9, 2019 Verastem, Inc. (Nasdaq: VSTM), operating as Verastem Oncology, (or "the Company"), focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported financial results for the three months ended March 31, 2019 (Press release, Verastem, MAY 9, 2019, View Source [SID1234536092]).

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"We are now into the second full quarter of the COPIKTRA launch and sales were up approximately 38% compared to the prior quarter," said Robert Forrester, President and Chief Executive Officer of Verastem Oncology. "We have also made substantial progress securing broader reimbursement for our product, with over 92% of targeted health plans now listing and providing reimbursement for COPIKTRA. We continue to receive positive feedback from physicians using COPIKTRA for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies or follicular lymphoma (FL) after at least two prior systemic therapies."

"The commercial team has been diligently working to enhance physician and advocacy group awareness of COPIKTRA, and to overcome certain historical misperceptions concerning the PI3K class. We believe the groundwork we have laid over the past several months will have an increasingly positive impact through 2019 and into next year. In parallel, we continue to advance duvelisib in additional lines of therapy, both as a monotherapy and in combination, as well as in additional indications like peripheral T-cell lymphoma (PTCL) for which preliminary data are expected by the end of this year," concluded Mr. Forrester.

Key First Quarter 2019 and Recent Accomplishments:

COPIKTRA (duvelisib)

Launched COPIKTRA in FL – In mid-March 2019, upon completion of the required 120-day waiting period following receipt of accelerated approval from the FDA, the Company launched its physician education and marketing campaign for COPIKTRA for the treatment of patients with FL after at least two prior systemic therapies. Accelerated approval in FL was based on overall response rate and continued approval may be contingent upon confirmatory trials, the first of which is expected to start in 2019.
Presented COPIKTRA Data at the 23rd Annual International Congress on Hematologic Malignancies (ICHM) – The Company presented four COPIKTRA abstracts at ICHM 2019, including an abstract highlighting Phase 3 DUO data in patients with relapsed or refractory CLL/SLL who have progressed following two prior lines of the therapy. This is the same indication for which COPIKTRA received approval from the FDA in September 2018. In this analysis, COPIKTRA demonstrated progression-free survival (PFS) of 16.4 months and an ORR of 78%, with a manageable safety profile. The remaining three abstracts featured data from a long-term (>2 years) efficacy and safety analysis, the Phase 3 DUO crossover extension study, and prognostic and immune-related factors associated with response to duvelisib from the Phase 2 DYNAMO study in indolent non-Hodgkin’s lymphoma (iNHL). Collectively, the data presented at ICHM 2019 continue to support the use of COPIKTRA in its approved indications of relapsed or refractory CLL/SLL after at least two prior therapies and FL after at least two prior systemic therapies. PDF copies of all of the ICHM 2019 poster presentations are available here.
Phase 2 DYNAMO Study Results Published in the Journal of Clinical Oncology – In February 2019, results of the Phase 2 DYNAMO study, which evaluated COPIKTRA in patients with indolent non-Hodgkin lymphoma (iNHL) who were refractory to both rituximab and chemotherapy or radioimmunotherapy, was published online in the peer-reviewed Journal of Clinical Oncology. The full manuscript, titled "DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients with Refractory Indolent Non-Hodgkin Lymphoma," (Flinn, et al. DOI: 10.1200/JCO.18.00915) can be accessed at www.ascopubs.org.
Continued Commercialization of COPIKTRA in the United States – Verastem Oncology launched COPIKTRA, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, in the United States following FDA approval for the treatment of adult patients with relapsed or refractory CLL/SLL after at least two prior therapies. COPIKTRA also received accelerated approval for the treatment of adult patients with relapsed or refractory FL after at least two prior systemic therapies.

COPIKTRA contains a BOXED WARNING for fatal and/or serious toxicities including infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. Verastem Oncology has implemented a Risk Evaluation and Mitigation Strategy to provide appropriate dosing and safety information to better support physicians in managing their patients on COPIKTRA.

Additionally, use of COPIKTRA is associated with other adverse reactions which may also require dose reduction, treatment delay or discontinuation of COPIKTRA.

Please see www.COPIKTRAHCP.com/prescribinginformation for full Prescribing Information including BOXED WARNING and Select Important Safety Information provided below.
Corporate and Financial

Chief Commercial Officer Joseph Lobacki to Step Down in 2019 – Joseph Lobacki, Chief Commercial Officer of Verastem Oncology will be stepping down from the Company in 2019 to pursue other professional opportunities, including Board of Director roles. Mr. Lobacki intends to continue in his role until the Company identifies and appoints a successor. During this transition, Brian Stuglik, RPh, a member of the Company’s Board of Directors and the former Chief Marketing Officer of Lilly Oncology, will provide strategic oversight and advisory support for the commercial organization.
Amended Hercules Loan Facility – In April 2019, the Company announced an amendment to its existing Loan and Security Agreement with Hercules Capital, Inc., changing key terms of the agreement, including a lower overall interest rate and an extended principal repayment timeline. The amendment also increases the borrowing limit from $50 million to $75 million in financing.
First Quarter 2019 Financial Results

Net product revenue for the 2019 Quarter was $1.7 million, which reflects the second full quarter of recorded sales for COPIKTRA. The Company did not have any product revenue for the 2018 Quarter as the FDA approved COPIKTRA on September 24, 2018.

Research and development (R&D) expense for the 2019 Quarter was $9.8 million, compared to $10.9 million for the 2018 Quarter. The decrease of $1.1 million, or 11%, was primarily related to a decrease in consulting fees as a result of activities to file a New Drug Application for COPIKTRA in the 2018 Quarter and lower R&D costs associated with the development of COPIKTRA as a result of site closures in the Company’s Phase 3 DUO and Phase 2 DYNAMO studies throughout 2018 and 2019 as patients continue to complete treatment. All of these lower costs were partially offset by an increase in costs related to the Phase 2 PRIMO study for the treatment of patients with relapsed or refractory PTCL.

Selling, general and administrative expense for the 2019 Quarter was $26.0 million, compared to $9.8 million for the 2018 Quarter. The increase of $16.2 million, or 165%, was primarily due to higher personnel and related costs, as well as promotional and consulting costs in support of the launch of COPIKTRA.

Net loss for the three months ended March 31, 2019 (2019 Quarter) was $38.1 million, or $0.52 per share (basic and diluted), as compared to $21.1 million, or $0.41 per share (basic and diluted), for the three months ended March 31, 2018 (2018 Quarter). In addition, net loss includes non-cash stock-based compensation expense of $2.2 million and $1.3 million for the 2019 and 2018 Quarters, respectively.

As of March 31, 2019, Verastem Oncology had cash, cash equivalents and short-term investments of $211.7 million.

Financial Outlook

For 2019, the Company expects net product revenue from sales of COPIKTRA to be in the range of $10-12 million, based on product revenue to date, current run rates and near-term expectations.

Conference Call and Webcast Information

The Verastem Oncology management team will host a conference call and webcast today, Thursday, May 9, 2019, at 4:30 PM (ET). The call can be accessed by dialing (877) 341-5660 (U.S. and Canada) or (315) 625-3226 (international), five minutes prior to the start of the call and providing the passcode 7199457.

The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the Company’s website at www.verastem.com. A replay of the webcast will be archived on the Company’s website for 90 days following the call.

About Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are cancers that affect lymphocytes and are essentially the same disease, with the only difference being the location where the cancer primarily occurs. When most of the cancer cells are located in the bloodstream and the bone marrow, the disease is referred to as CLL, although the lymph nodes and spleen are often involved. When the cancer cells are located mostly in the lymph nodes, the disease is called SLL. The symptoms of CLL/SLL include a tender, swollen abdomen and feeling full even after eating only a small amount. Other symptoms can include fatigue, shortness of breath, anemia, bruising easily, night sweats, weight loss, and frequent infections. However, many patients with CLL/SLL will live for years without symptoms. In 2018, there were approximately 200,000 patients in the United States affected by CLL/SLL with nearly 20,000 new diagnoses. While there are therapies currently available, real-world data reveals that a significant number of patients either relapse following treatment, become refractory to current agents, or are unable to tolerate treatment, representing a significant medical need. The potential of additional oral agents, particularly as a monotherapy that can be used in the general community physician’s armamentarium, may hold significant value in the treatment of patients with CLL/SLL.

About Follicular Lymphoma

Follicular lymphoma (FL) is typically a slow-growing or indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes, making it a B-cell lymphoma. In 2018, this lymphoma subtype accounted for 20 to 30 percent of all NHL cases, with more than 140,000 people in the United States with FL and more than 13,000 newly diagnosed patients. Common symptoms of FL include enlargement of the lymph nodes in the neck, underarms, abdomen, or groin, as well as fatigue, shortness of breath, night sweats, and weight loss. Often, patients with FL have no obvious symptoms of the disease at diagnosis. Follicular lymphoma is usually not considered to be curable, but more of a chronic disease, with patients living for many years with this form of lymphoma. The potential of additional oral agents, particularly as a monotherapy that can be used in the general community physician’s armamentarium, may hold significant value in the treatment of patients with FL.

About Peripheral T-Cell Lymphoma

Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma (NHL) that develops in mature white blood cells called "T cells" and "natural killer (NK) cells"1 which circulate with the lymphatic system.2 PTCL accounts for between 10-15% of all non-Hodgkin lymphomas (NHLs) and generally affects people aged 60 years and older.1 Although there are many different subtypes of peripheral T-cell lymphoma, they often present in a similar way, with widespread, enlarged, painless lymph nodes in the neck, armpit or groin.2 There is currently no established standard of care for patients with relapsed or refractory disease.1

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.3,4,5 COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.6 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

On May 9, 2019 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), reported consolidated financial results for the fiscal 2019 second quarter ended March 31, 2019 (Press release, Applied DNA Sciences, MAY 9, 2019, View Source [SID1234536091]).

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"We successfully closed on a definitive agreement with TheraCann that contained the largest payment transaction in company history. This new revenue stream beachhead from legal cannabis sits beside the considerable progress we have made in driving adoption of our DNA technology platform and its commercialization across global textile industries," stated Dr. James A. Hayward, president and CEO of Applied DNA. "Our exclusive cannabis licensing and cooperation agreement with TheraCann secures $5 million in up-front payments by August 15, 2019 (of which $1 million has already been received) and includes annual minimum commitments that scale over time to $20 million in order to maintain the exclusive license. Powered by our CertainT platform, TheraCann’s ETCH biotrace system can offer the global legal cannabis and hemp industries what we believe is an unparalleled ability to ensure true authentication and provenance verification."

"Growing worldwide demand for legalized cannabis is driving the creation of global supply chains that need to be secured and validated from inception through consumption. TheraCann’s market position, together with our proven molecular tags and application and authentication systems, is yielding a pipeline of opportunities that spans interest from numerous countries wanting to protect their licensed cannabis supply chain to commercial trials for international export opportunities."

Continued Dr. Hayward, "Within our textile practice, our initiatives to further penetrate the very large synthetic fiber market are beginning to bear fruit. Initial volumes of goods tagged under our CertainT licensing platform are now appearing at retail via Amazon.com and on the store shelves of a big box retailer in North America. We are also executing on our strategy to engage key participants along multiple points in the global textile value chain to more broadly drive adoption of our platform. To that end, we are today involved in active pilot projects with fiber manufacturers that cumulatively represent approximately 50% of the annual global market for viscose. In cotton, after the close of the quarter, we announced our entry into the Egyptian cotton market to demonstrate the same level of authenticity and accountability to manufacturers of luxury Egyptian cotton products as we have to the U.S. cotton industry.

"Cannabis, textiles and our wholly-owned subsidiary, LineaRx are expected to drive our top-line performance for the balance of fiscal 2019 while we also progress nascent opportunities in other industries, including pharmaceuticals, " concluded Dr. Hayward. "We believe market trends are becoming tailwinds for us: sustainability in manufacturing is becoming increasingly relevant to today’s consumer, and manufacturers are seeking to elevate brands and products by establishing the transparency and truth that consumers desire. Our DNA technology platform can be the basis for the trust that both sides seek."

Fiscal Second Quarter 2019 Financial Results:

Revenues decreased 25% for the second quarter of fiscal 2019 to $778 thousand, compared with $1.0 million reported in the second quarter of fiscal 2018, and decreased 12% from the $884 thousand reported in the first fiscal quarter ended December 31, 2018. The year-over-year decrease in revenues was due primarily to a decrease in product revenues of $315 thousand from our biopharmaceutical and consumer asset marking verticals. The quarter-over-quarter decrease in revenues reflects the fulfillment of a cotton order during the first quarter of fiscal 2019.
Effective October 1, 2018, the Company was required to adopt Accounting Standards Update (ASU; the "Update") No. 2014-09, Revenue from Contracts with Customers (Topic 606), utilizing the modified retrospective method. Had the Company not adopted the Update, the Company would have recognized additional revenue of approximately $440 thousand and $830 thousand during the second quarter and first six months of fiscal 2019, respectively. These amounts were primarily comprised of the recognition of $383 thousand and $766 thousand during the three and six months periods ended March 31, 2019, respectively, under a $1.15 million cotton order shipped in June 2018, with extended payment terms. The total cumulative impact of the Update that was recorded to opening retained earnings in fiscal 2019 was approximately $494 thousand. See Cumulative Effect Adjustment and the Impact on Current Period Financial Statements of Adopting Topic 606 attached.
Total operating expenses increased to $3.3 million for the second fiscal quarter of 2019, compared with $2.8 million in the prior fiscal year’s second quarter. This increase is primarily attributable to an increase in stock-based compensation expense.
Net loss for the quarter ended March 31, 2019 was $2.7 million, or $0.08 per share, compared with a net loss of $2.1 million, or $0.07 per share, for the quarter ended March 31, 2018 and a net loss of $3.2 million, or $0.11 per share for the quarter ended December 31, 2018.
Excluding non-cash expenses, Adjusted EBITDA was negative $2.3 million for the quarters ended March 31, 2019 and 2018. See below for information regarding non-GAAP measures.
Six-Month Financial Highlights:

Revenues for the first six months of fiscal 2019 totaled $1.66 million, a decrease of 2% from $1.69 million from the same period in the prior fiscal year. The decrease in revenues was due to a decrease in product revenue of $343 thousand, or 41%, offset by an increase in service revenues of $315 thousand, or 37%.
Operating expenses for the six months ended March 31, 2019 increased by $902 thousand or 14% for the same period last fiscal year. The increase is primarily attributable to an increase in stock-based compensation, offset to a lesser extent by decreases in R&D and depreciation and amortization expenses.
Net loss for the six months ended March 31, 2019 was $5.9 million or $0.16 per share, compared with a net loss of $5.3 million or $0.18 per share for the six months ended March 31, 2018.
Excluding non-cash expenses and interest, Adjusted EBITDA for the six months ended March 31, 2019 was a negative $4.9 million as compared to a negative $5.1 million for the same period in the prior fiscal year. See below for information regarding non-GAAP measures.
Select Recent Operational Highlights:

On May 7th, the Company and American & Effird ("A&E")announced that A&E will be previewing its new line of advanced molecular-tagged identification threads, branded "integrity", later this month. A&E will publicly display this latest breakthrough at the upcoming Texprocess show in Frankfurt Germany.
On April 29, 2019, Applied DNA’s wholly-owned subsidiary, LineaRx announced that it has improved expression levels and survival rates of linear DNA constructs delivered to human T cells without viruses or plasmids. In collaboration with Avectas, a cell engineering technology business enabling the manufacture of cell therapies, LineaRx has achieved a greater than four-fold increase in cell survival, and a more than 50% increase in linear gene expression of a model amplicon. Results were presented by Avectas two weeks ago at the Cell & Gene Meeting on the Mediterranean, attended by more than 50 companies.
On April 22, 2019, the Company and GHCL announced the launch of "REKOOP" on Amazon.com. REKOOP is verified by the Company’s CertainT platform. The "REKOOP" range of bedding products is meant for the ecologically conscious consumer who is making purchase decisions to support the environment and is supportive of initiatives that help reduce the carbon footprint.
On April 11, 2019, Applied DNA announced the signing of a non-binding MOU with Netherlands-based Stahl. Under the terms of the MOU, the parties will continue the evaluation of molecular tagging of process chemicals and coatings utilizing Stahl’s product offerings as a point of entry into supply chains for the Company’s molecular tags. Stahl will provide technical expertise to the company relating to the process chemicals used in leather manufacturing.
On April 8, 2019, the Company’ announced that its wholly owned subsidiary, LineaRx, achieved what it believes to be a biotech industry first with Anti-CD19 expression in human CAR T cells via proprietary non-viral, plasmid-free platform.
On April 2, 2019, Loftex, a leading manufacturer of high-quality towels, announced that the first retail introduction of their bath towels including recycled PET (rPET) source-verified by Applied DNA’s CertainT platform are now available at US retail this month. Loftex introduced the eco-friendly towel, partially comprised of rPET materials as part of their commitment to sustainability both in their factory and in their products.
On March 29, 2019, the Company signed an exclusive cannabis licensing and cooperation agreement with Theracann International. As part of the agreement, Applied DNA is to receive staged payments totaling $5 million by August 15, 2019. The Company announced that the first payment of $1 million was received during April 2019. The agreement also calls for annual payment minimums that scale from $7 million in year three to $20 million in year fifteen to maintain license exclusivity.
On March 1, 2019, Applied DNA announced that its wholly owned subsidiary, LineaRx and Takis/Evvivax are progressing linear DNA for use as a cancer vaccine. LineaRx shipped TK7 and ConTRT amplicons to Takis/Evvivax in early March as part of the companies’ Joint Development Agreement entered into during September 2018.
Fiscal Second Quarter 2019 Conference Call Information

The Company will hold a conference call and webcast to discuss its fiscal second quarter-end 2019 results on Thursday, May 9, 2019 at 4:30 PM ET. To participate on the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, due to the large number of expected participants, not all questions may be answered.

To Participate:

Participant Toll Free: 1-844-887-9402
Participant Toll: 1-412-317-6798
Please ask to be joined to the Applied DNA Sciences call
Live webcast: View Source

Replay (available 1 hour following the conclusion of the live call through May 16, 2019):

Participant Toll Free: 1-877-344-7529
Participant Toll: 1-412-317-0088
Participant Passcode: 10130964
Webcast replay: View Source
For those investors unable to attend the live call, a copy of the presentation is expected to be posted by end of business on May 10, 2019 and available under the ‘Events and Presentations’ section of the company’s Investor Relations web site: View Source

Information about Non-GAAP Financial Measures

As used herein, "GAAP" refers to accounting principles generally accepted in the United States of America. To supplement our condensed consolidated financial statements prepared and presented in accordance with GAAP, this earnings release includes Adjusted EBITDA, which is a non-GAAP financial measure as defined in Rule 101 of Regulation G promulgated by the Securities and Exchange Commission. Generally, a non-GAAP financial measure is a numerical measure of a company’s historical or future performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information presented in accordance with GAAP. We use this non-GAAP financial measure for internal financial and operational decision making purposes and as a means to evaluate period-to-period comparisons of the performance and results of operations of our core business. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the performance of our business by excluding non-cash expenses that may not be indicative of our recurring operating results. We believe this non-GAAP financial measure is useful to investors as they allow for greater transparency with respect to key metrics used by management in its financial and operational decision making.

"EBITDA"- is defined as earnings (loss) before interest expense, income tax expense and depreciation and amortization expense.

"Adjusted EBITDA"- is defined as EBITDA adjusted to exclude (i) stock-based compensation and (ii) other non-cash expenses.

On May 9, 2019 Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, reported financial results for the first quarter ended March 31, 2019 (Press release, Vaxart, MAY 9, 2019, View Source [SID1234536090]).

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"With the Phase 1b study of our bivalent norovirus tablet vaccine underway and two successful financings behind us, we are well positioned to advance our lead product candidate, the first oral vaccine against norovirus, the leading cause of food-borne illness in the U.S.," said Wouter Latour, M.D., chief executive officer of Vaxart. "We expect to initiate the Phase 2 monovalent norovirus challenge study in the first half of 2019, and we expect topline results from both the Phase 1b and Phase 2 studies in the second half of 2019. In addition, we are advancing our first therapeutic vaccine for the treatment of HPV associated cervical dysplasia and cancer toward the clinic."

2019 Highlights:

Corporate:

On March 8, Vaxart announced the initiation of the open label lead-in portion of its Phase 1b bivalent norovirus vaccine clinical trial. On March 27, the Company announced it had completed dosing of the lead-in cohort, and on April 16 the first patient in the randomized cohort of the clinical trial was dosed.
On March 19, Vaxart announced the pricing of a registered direct offering of 1,200,000 shares of its common stock at a price of $2.50 per share. Total gross proceeds from the offering were $3.0 million.
On April 1, at the International Society for Influenza and other Respiratory Virus Diseases conference in Siena, Italy, and on April 3, at the Influenza Vaccines for the World 2019 conference in Edinburgh, Scotland, Vaxart presented new data from its Phase 2 influenza challenge study further solidifying the evidence that its oral tablet vaccine protects against influenza infection, primarily through mucosal immunity.
On April 9, Vaxart announced the pricing of an underwritten public offering of a total of 925,455 shares of common stock and 8,165,455 pre-funded warrants with an exercise price of $0.10 per share, as well as common warrants for 10,454,546 shares with an exercise price of $1.10 per share. The gross proceeds of the offering at close were $9.3 million. As of May 8, 2019, 6,519,091 pre-funded warrants had been exercised, bringing the aggregate gross proceeds up to $10.0 million, and 1,646,364 pre-funded warrants remained outstanding.
On April 13, at the 29th European Congress of Clinical Microbiology and Infectious Diseases in Amsterdam, the Netherlands, Vaxart presented preclinical data showing that Vaxart’s oral quadrivalent seasonal influenza vaccine conferred 100% protection against a lethal H5N1 pre-pandemic influenza challenge in ferrets, while in the Fluzone group only 62% of the animals survived.
Financial Results for the Three Months Ended March 31, 2019

Vaxart reported a net loss of $1.3 million for the first quarter of 2019 compared to net income of $2.3 million for the first quarter of 2018. The principal reason for the decrease was the absence of a $7.0 million one-off non-cash bargain purchase gain recorded in the first quarter of 2018, partially offset by an increase in revenue of $3.9 million, primarily from royalties on Inavir and Relenza.
Vaxart ended the quarter with cash and cash equivalents of $8.4 million compared to $11.5 million at December 31, 2018. The decrease was primarily due to cash used in operations, partially offset by the $2.5 million net raised in the registered direct offering in March 2019.
Revenue for the quarter was $5.4 million compared to $1.5 million in the first quarter of 2018. The $3.9 million increase was principally due to royalty revenue resulting from our merger with Aviragen being recorded for the full quarter in 2019, while in 2018 the majority of this revenue was earned pre-merger.
Research and development expenses were $3.8 million for the quarter compared to $3.4 million for the first quarter of 2018. The increase was mainly due to higher clinical and manufacturing costs incurred in the Company’s norovirus program and amortization of intangible assets acquired in the merger with Aviragen, partially offset by the discontinuation of the teslexivir program and completion of the BARDA contract.
General and administrative expenses were $2.0 million for the quarter, substantially unchanged from the first quarter of 2018.

On May 9, 2019 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported financial results for the three-month period ended March 31, 2019 (Press release, Spectrum Pharmaceuticals, MAY 9, 2019, View Source [SID1234536089]).

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"We are well on our way to fully executing our strategy for Spectrum," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "The Q1 sale of our portfolio of legacy oncology products provided cash and allowed us to focus on our late-stage assets as well as new growth opportunities. Earlier today, we announced the acquisition of two new assets and a novel antibody-interferon fusion technology platform that could have broad application in oncology. With key near-term catalysts for poziotinib and ROLONTIS and two newly acquired assets, we are building a robust oncology pipeline."

Pipeline Overview

Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations

Topline results from the EGFR previously treated non-small cell lung cancer cohort (cohort 1) in the ZENITH20 trial are expected in Q4 2019; data from cohort 1 are intended to support a New Drug Application (NDA) filing with the FDA.
Enrollment for the HER2 previously treated non-small cell lung cancer cohort (cohort 2) is progressing ahead of previous expectations that enrollment would be complete in Q4. This cohort also has the potential to support an NDA filing with the FDA in the future.
ROLONTIS (eflapegrastim), a novel long-acting GCSF

Integrated data from the two Phase 3 ROLONTIS clinical trials (n = 643) will be presented in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 annual meeting.
Spectrum is working on filing the ROLONTIS BLA as soon as possible.
Business Development

Spectrum completed an asset purchase and license agreement for a novel immuno-oncology platform and two early stage assets. Originally developed by scientists at UCLA and licensed to Spectrum by UCLA Technology Development Group, the FIT platform fuses interferon with various monoclonal antibodies targeting various tumor antigens and potentially has broad application in oncology. The license also includes two novel assets derived from this platform.
The first asset is an antibody-interferon fusion molecule directed against CD20 (Anti-CD20-IFNá). This drug candidate is in Phase 1 development for treating relapsed or refractory non-Hodgkin lymphoma, including diffuse large b-cell lymphoma patients where a considerable unmet medical need exists. Research for this program received financial support through the Therapy Acceleration Program of The Leukemia & Lymphoma Society, Inc. (LLS), and an LLS research grant to UCLA.
The second asset is an antibody-interferon fusion molecule directed against GRP94, a target for which currently there are no existing approved therapies. It has the potential for treating both solid and hematologic malignancies.
Three-Month Period Ended March 31, 2019 (All numbers are from Continuing Operations and are approximate)

GAAP Results

Spectrum recorded a loss of $39.8 million, or a loss of $0.36 per basic and diluted share, in the three-month period ended March 31, 2019, compared to a loss of $19.2 million, or a loss of $0.19 per basic and diluted share, in the comparable period in 2018. Total research and development expenses were $21.9 million in the quarter, as compared to $13.4 million in the same period in 2018. Selling, general and administrative expenses were $16.0 million in the quarter, compared to $16.6 million in the same period in 2018.

Non-GAAP Results

Spectrum recorded a non-GAAP loss of $29.2 million, or a non-GAAP loss of $0.27 per basic and diluted share, in the three-month period ended March 31, 2019, compared to a non-GAAP net loss of $26.8 million, or a non-GAAP loss of $0.27 per basic and diluted share, in the comparable period in 2018. Non-GAAP research and development expenses were $20.4 million, as compared to $12.7 million in the same period of 2018. Non-GAAP selling, general and administrative expenses were $10.7 million, as compared to $14.3 million in the same period in 2018.

Conference Call

Thursday, May 9, 2019 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 4290388
International: (973) 796-5077, Conference ID# 4290388
This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: www.sppirx.com on May 9, 2019 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

On May 9, 2019 Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, reported that the company will participate in two upcoming healthcare conferences taking place in New York City during May (Press release, Gamida Cell, MAY 9, 2019, View Source [SID1234536088]).

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On Thursday, May 16, 2019, members of Gamida Cell’s management team will participate in investor meetings at the Oppenheimer & Co. Oncology Insight Summit.

Additionally, Julian Adams, Ph.D., chief executive officer of Gamida Cell, will participate in a "fireside chat" at the RBC Capital Markets Global Healthcare Conference on Tuesday, May 21, 2019, at 11:00 a.m. ET. A live webcast of the presentation will be available on the Investors section of the Gamida Cell website, www.gamida-cell.com.