On August 6, 2018 Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, reported financial results and business highlights for the second quarter ended June 30, 2018 (Press release, Vericel, AUG 6, 2018, View Source [SID1234528625]).

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Second Quarter 2018 Financial Highlights

Total net revenues of $19.0 million compared to $17.0 million in the second quarter of 2017; second quarter 2017 revenues included a favorable $1.4 million reversal of a revenue reserve for Carticel and MACI related to a contractual dispute between one of the Company’s pharmacy providers and a third-party payer;

Gross margins of 59% compared to gross margins of 55% on a GAAP basis and 51% on a non-GAAP basis excluding the impact of the revenue reserve reversal in the second quarter of 2017;

Net loss of $4.7 million, or $0.12 loss per share, compared to net loss of $2.4 million, or $0.07 per share on a GAAP basis and $3.7 million, or $0.11 per share, on a non-GAAP basis excluding the impact of the revenue reserve reversal, in the second quarter of 2017;

Non-GAAP adjusted EBITDA loss of $1.4 million compared to a loss of $2.7 million in the second quarter of 2017;

As of June 30, 2018, the company had $95.0 million in cash compared to $26.9 million in cash at December 31, 2017; and

Full year 2018 revenue guidance raised to $80 to $83 million compared to previous full year revenue guidance of $73 to $78 million.
Recent Business Highlights
During and since the second quarter of 2018, the company:

Reported record second quarter revenues marking the fifth consecutive quarter with record revenues for the reported quarter;

Deployed the expanded MACI sales force, which increased from 28 to 40 sales representatives;

Completed an expansion of MACI manufacturing capacity to support expected growth in MACI demand;
Implemented an expanded pharmacy distribution network to continue expansion of MACI payer access;

Closed a $74.8 million public offering; and

Joined the Russell 3000 Index.
"We continued our strong start to 2018 with solid revenue growth and expanding margins in the second quarter, and we believe that key performance indicators point to continued robust growth for MACI in the second half of the year," said Nick Colangelo, president and CEO of Vericel. "Moreover, based on our strengthened financial position, we are well positioned to execute on our business and strategic plans."

Second Quarter 2018 Results
Total net revenues for the quarter ended June 30, 2018 were $19.0 million, which included $14.1 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $4.9 million of Epicel (cultured epidermal autografts) net revenue, compared to $12.9 million of Carticel (autologous cultured chondrocytes) and MACI net revenue and $4.0 million of Epicel net revenue, respectively, in the second quarter of 2017. Total net revenues for the quarter ended June 30, 2017 included a favorable $1.4 million reversal of a revenue reserve for Carticel and MACI related to a contractual dispute between one of the Company’s pharmacy providers and a third-party payer.
Gross profit for the quarter ended June 30, 2018 was $11.3 million, or 59% of net revenues, compared to $9.3 million, or 55% of net revenues on a GAAP basis and 51% on a non-GAAP basis excluding the impact of the revenue reserve reversal, for the second quarter of 2017. See table reconciling non-GAAP measures for more details.
Total operating expenses for the quarter ended June 30, 2018 were $15.5 million compared to $11.8 million for the same period in 2017. The increase in operating expenses was due primarily to a $1.7 million increase in stock-based compensation expense, a $1.6 million increase in MACI related sales and marketing activities, and $0.7 million increase in R&D expense related to the preparations for a MACI pediatric clinical study in the U.S.
Loss from operations for the quarter ended June 30, 2018 was $4.2 million, compared to a loss of $2.5 million on a GAAP basis and $3.9 million on a non-GAAP basis excluding the impact of the revenue reserve reversal for the second quarter of 2017. Material non-cash items impacting the operating loss for the quarter in the current year included $2.5 million of stock-based compensation expense and $0.4 million in depreciation expense, compared to $0.8 million of

stock-based compensation expense and $0.4 million in depreciation expense in the second quarter of 2017.
Other expense for the quarter ended June 30, 2018 was $0.4 million compared to other income of $0.1 million for the second quarter of 2017.
Non-GAAP adjusted EBITDA loss was $1.4 million for the quarter ended June 30, 2018 compared to a loss of $2.7 million in the second quarter of 2017.
Vericel’s net loss for the quarter ended June 30, 2018 was $4.7 million, or $0.12 per share, compared to a net loss of $2.4 million, or $0.07 per share on a GAAP basis and $3.7 million, or $0.11 per share on a non-GAAP basis excluding the impact of the revenue reserve reversal, for the second quarter of 2017.
As of June 30, 2018, the company had $95.0 million in cash compared to $26.9 million in cash at December 31, 2017.
Full Year 2018 Financial Guidance
The company now expects total net product revenues for the full year 2018 to be in the range of $80 to $83 million, compared to the previous full year revenue guidance of $73 to $78 million.
Conference Call Information
Today’s conference call will be available live at 4:30pm Eastern time in the Investor Relations section of the Vericel website at View Source." target="_blank" title="View Source." rel="nofollow">View Source Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s second-quarter 2018 investor conference call. If calling from outside the U.S., please use the international phone number (253) 237-1173.
If you are unable to participate in the live call, the webcast will be available at View Source until August 6, 2019. A replay of the call will also be available until 7:30pm (EDT) on August 11, 2018 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 9699288.

On August 6, 2018 Almac Discovery, a biopharmaceutical company focused on discovering and identifying innovative therapeutics for the treatment of cancer, and Elasmogen, an SME focused on the development of next generation biologics, reported that they have been awarded a grant from Innovate UK through its Innovation in Health and Life Sciences funding programme (Press release, Elasmogen, AUG 6, 2018, View Source [SID1234637763]).

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The £2M peer reviewed collaborative project entitled ‘A Technology Platform for Next Generation VNAR based Oncology Medicines’, plans to utilise the highly selective, high affinity and yet low molecular weight non-antibody VNAR protein scaffold and build a versatile platform to facilitate the discovery and development of targeted oncology therapeutics.

The VNAR structure allows ready access for protein engineering of multiple formats. These VNAR formats can be optimised, with or without conjugation of a cytotoxic payload, with further conversion to soloMER format, to become a first-in-class or best-in-class targeted therapeutic. The two year project optimises both target binding and selectivity, via the identification of novel epitopes and formats, approaches to linker design and payload attachments, and further builds upon the experimental data supporting the unique attributes of VNARs.

Almac first entered into an agreement with Elasmogen for the treatment of solid tumours in 2015. This new joint research programme broadens the collaborative work by combining Almac Discovery’s expertise in protein engineering and oncology drug discovery with Elasmogen’s expertise in the generation, screening and formatting of VNAR proteins.

Stephen Barr, President & Managing Director, Almac Discovery commented: "We are delighted to have secured this highly sought after funding from Innovate UK to support this novel field of research which is testament to the novelty of the proposed approach and the quality of the underlying technologies involved. It is heartening to be able to continue and also broaden our successful collaboration with Elasmogen so that we may remain at the forefront of oncology discovery and ultimately benefit patients."

"Given the devastating and wide-ranging impact of cancer on the lives of so many people, there is a continual need to bring new innovative therapies into the clinic" said Caroline Barelle, Chief Executive Officer, Elasmogen. "I have no doubt that by combining the oncology expertise of Almac with the advantages of our soloMER platform that we can deliver a new class of drugs to patients".

Innovate UK is the UK’s innovation agency working with people, companies and partner organisations to find and drive science and technology innovations that will grow the UK economy.

Future research of next generation VNAR-based oncology medicines, as a result of this investment, will be co-funded by the UK’s innovation agency, Innovation UK, Elasmogen and Almac Group.

On August 6, 2018 Harpoon Therapeutics, an immuno-oncology company pioneering a new class of T cell engaging therapeutics, reported that the first patient has been treated with HPN424 in a Phase 1 clinical study of metastatic castration-resistant prostate cancer (mCRPC) patients (Press release, Harpoon Therapeutics, AUG 6, 2018, View Source [SID1234528457]). HPN424 is the first of multiple compounds in development that are based on the company’s TriTAC (Tri-specific T cell Activating Construct) platform and designed to penetrate solid tumors, have extended serum half-life, and recruit patients’ own T cells to destroy malignant tumor cells.

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The Phase 1 trial is a multicenter, multinational, open-label, ascending dose study designed to evaluate the safety, tolerability and pharmacokinetics of HPN424 in approximately 40 patients with metastatic prostate cancer.

"We are pleased to initiate Harpoon’s first clinical trial with HPN424 in patients with advanced prostate cancer, an important milestone that marks our transition to a clinical-stage company," said Jerry McMahon, PhD, President and Chief Executive Officer of Harpoon Therapeutics. "HPN424 is the first TriTAC compound to enter clinical testing and represents a novel class of T cell therapeutics aiming to achieve superior efficacy in penetrating and killing solid tumors. Data is expected in 2019, and should provide the safety assessment, pharmacokinetics and pharmacodynamics to determine the optimal dose and regimen for our additional planned trials in prostate cancer, the third leading cause of cancer deaths for men in the U.S."

In the first phase of the study, HPN424 will be administered once weekly to patients via intravenous (IV) infusion with dose escalation until a therapeutic dose level has been reached. Following dose escalation, Harpoon will further evaluate the safety and efficacy of HPN424 in additional cohorts of patients at the recommended Phase 2 dose established in the first phase of the study. For more information about the trial, please visit clinicaltrials.gov, identifier number NCT03577028.

"Immunology represents a new frontier for the treatment of prostate cancer," said Charles G. Drake, MD, PhD, Director of Genitourinary Oncology at New York Presbyterian/Columbia University Cancer Center, Co-director of Columbia’s Cancer Immunotherapy Program and Scientific Advisory Board member at Harpoon. "Each year in the U.S., approximately 26,000 men die from prostate cancer following treatment with current available therapies. HPN424, an innovative biologic designed to activate T cells in the tumor, is highly potent in killing prostate cancer cells in preclinical models and could be a promising option for these men with advanced disease."

"HPN424 is designed as an ‘off-the-shelf’ T cell therapy which can overcome loss of human leukocyte antigen (HLA) expression – a frequent mechanism by which cancer cells escape T cell recognition," said Che-Leung Law, PhD, Vice President of Translational Medicine. "Pharmacological insights gleaned from the study should help inform development of both HPN424 and our pipeline of additional products – targeting mesothelin (MSLN), B-cell maturation antigen (BCMA) and DLL3 – in the near future."

About HPN424

HPN424 is a 50-kD single polypeptide that contains three binding domains — for human PSMA, human serum albumin and human CD3. In preclinical studies, HPN424 demonstrated single-digit picomolar potency for PSMA-dependent T cell killing in a panel of human prostate cancer cell lines, which translated to in vivo efficacy with efficacious doses in the low μg/kg range. HPN424 was well tolerated in a multi-dose safety study in non-human primates and showed a serum half-life of about 80 hours supporting once-weekly administration. AACR (Free AACR Whitepaper)_2018_Poster_HPN424

On August 6, 2018 Kura Oncology, Inc., (Nasdaq: KURA) a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported second quarter 2018 financial results and provided a corporate update (Press release, Kura Oncology, AUG 6, 2018, View Source [SID1234528626]).

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"I am very pleased with the continued progress we made over the past quarter, with a particular focus on operational execution," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We have enhanced our leadership team, improved our ability to screen and identify patients with HRAS mutations, positioned our pipeline to create additional opportunities and strengthened our balance sheet through a successful public offering. We believe the proceeds from this offering along with our existing funds give us the resources to advance our pipeline through a series of potential milestones, including data from a registration-directed trial of our lead drug candidate tipifarnib in HRAS mutant HNSCC."

Corporate Update

Updated data from RUN-HN at ESMO (Free ESMO Whitepaper) – An abstract relating to Kura’s ongoing Phase 2 trial of tipifarnib in HRAS mutant HNSCC has been accepted for oral presentation at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in Munich in October. The update will also include patients from an exploratory cohort in other HRAS mutant squamous cell carcinomas. Approximately 25 clinical sites are now open for enrollment worldwide and RUN-HN is currently enrolling at a rate of approximately two patients per month.

Screening collaboration to support enrollment – The company has signed an agreement with OncoDNA, an oncology-focused healthcare technology company based in Belgium, to support patient enrollment for Kura’s ongoing Phase 2 trial of tipifarnib in patients with HRAS mutant HNSCC. OncoDNA provides physicians internationally with next-generation sequencing for HNSCC oncogenic mutations, including HRAS, for patients who may be eligible to enroll in RUN-HN.

Registration-directed trial anticipated to initiate by year end – Kura has initiated startup activities for its upcoming registration-directed trial of tipifarnib in at least 59 recurrent or metastatic patients with HRAS mutant HNSCC. The company anticipates that the trial will be conducted at approximately 100 clinical sites worldwide and will take approximately two years to enroll. Based on feedback from the U.S. Food and Drug Administration, Kura believes that the single-arm trial, if positive, could support an application for accelerated approval.

HRAS mutant lung squamous cell carcinoma (LSCC) – An investigator-sponsored trial of tipifarnib in HRAS mutant LSCC has been initiated and is now open for enrollment. The proof-of-concept trial is being conducted in collaboration with the Spanish Lung Cancer Group, a cooperative group consisting of more than 150 public and private oncology centers in Spain.

Biomarker-enriched data in hematologic malignances – Kura is prospectively investigating the CXCL12 pathway and bone marrow homing as potential biomarkers of activity for tipifarnib in its three ongoing Phase 2 trials in hematologic malignancies. The PTCL trial was the first of the three to begin and is actively enrolling into two cohorts: 1) Patients with angioimmunoblastic T-cell lymphoma (AITL) and 2) patients with PTCL who have the absence of a single nucleotide variation in the 3’ untranslated region of the CXCL12 gene. The company expects to have biomarker-enriched data from PTCL and potentially other indications by the end of 2018.

Strengthened management team – Kura expanded its leadership team with the additions of Marc Grasso, M.D., and John Farnam. Dr. Grasso will join the company as Chief Financial Officer and Chief Business Officer on August 21, 2018, after 20 years in healthcare investment banking. Mr. Farnam joined Kura in the newly created position of Chief Operating Officer on July 1, 2018, from Celgene Receptos. The company has also added industry veterans Bridget Martell, M.D., and Blake Tomkinson, Ph.D., as Vice Presidents of Clinical Development.

Public offering of common stock – On July 2, 2018, Kura completed a public offering in which the company sold an aggregate of 4,600,000 shares of common stock at a price of $16.75 per share. Net proceeds from the public offering, after deducting underwriting discounts, commissions and offering expenses, were approximately $74.5 million.

Upcoming Milestones

Update from ongoingPhase 2 trial of tipifarnib in HRAS mutant HNSCC at ESMO (Free ESMO Whitepaper) in October 2018

Initiation of registration-directed trial of tipifarnib in HRAS mutant HNSCC by the end of 2018

Dosing of first patient in investigator-sponsored study of tipifarnib in HRAS mutant LSCC

Biomarker-enriched data from Phase 2 trial of tipifarnib in PTCL by the end of 2018

Submission of an investigational new drug application for KO-539, a potent and selective menin-MLL inhibitor, in late 2018 or early 2019

Financial Results

Research and development expenses for the second quarter of 2018 were $11.5 million, compared to $5.7 million for the second quarter of 2017.

General and administrative expenses for the second quarter of 2018 were $3.8 million, compared to $2.3 million for the second quarter of 2017.

Net loss for the second quarter of 2018 was $14.7 million, or $0.45 per share, compared to $7.8 million, or $0.40 per share, for the second quarter of 2017.

Cash, cash equivalents and short-term investments totaled $125.9 million as of June 30, 2018, compared with $93.1 million as of December 31, 2017.

As adjusted for the $74.5 million in net proceeds resulting from the company’s public offering of common stock that closed on July 2, 2018, Kura had, on a pro forma basis, $200.4 million in cash, cash equivalents and short-term investments at June 30, 2018.

Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund its current operations through 2021.

Conference Call and Webcast

Kura’s management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT today, August 6, 2018, to discuss the financial results for the second quarter of 2018 and provide a corporate update. The live call may be accessed by dialing (877) 516-3514 for domestic callers and (281) 973-6129 for international callers

and entering the conference code: 1588245. A live webcast of the call will be available from the Investors and Media section of the company website at www.kuraoncology.com, and will be archived there for 30 days.

On August 6, 2018 Editas Medicine, Inc. (NASDAQ: EDIT), a leading genome editing company, reported financial results for the second quarter ended June 30, 2018, and provided an update on recent achievements and upcoming events (Press release, Editas Medicine, AUG 6, 2018, View Source;p=RssLanding&cat=news&id=2362273 [SID1234528651]).

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"During the second quarter, we continued to drive towards our first IND and to advance our broader pipeline of transformative CRISPR medicines," said Katrine Bosley, President and Chief Executive Officer of Editas Medicine. "Our lead candidate, EDIT-101 to treat the genetic disease LCA10, is poised to be the first in vivo CRISPR medicine in human trials with an anticipated IND filing in October. Our broader pipeline of ocular and engineered cell medicines is advancing as well."

Recent Achievements and Outlook

Allergan Pharmaceuticals International Limited (Allergan) exercises option to develop and commercialize EDIT-101 globally and Editas exercises option to co-develop and equally share profits and losses in the United States. Editas and Allergan announced today that Allergan has exercised its option for EDIT-101 and Allergan has paid an option exercise fee of $15 million, which will be recorded in the third quarter. In addition, Editas is eligible to receive a $25 million milestone payment from Allergan upon clearance of an IND application for EDIT-101.

EDIT-101 advancing towards clinical trials with NIH filing submitted in July and IND filing anticipated in October 2018. Editas submitted the requisite data package for human gene transfer clinical protocol registration to the United States National Institutes of Health (NIH) for potential review by the Recombinant DNA Advisory Committee. Editas plans to file an IND application for EDIT-101 with the United States Food and Drug Administration in October 2018. In addition, the Company presented new pre-clinical data on EDIT-101 at the American Society of Gene & Cell Therapy 21st Annual Meeting (ASGCT Meeting) demonstrating that EDIT-101 was well tolerated in a study of non-human primates (NHPs). Therapeutically relevant levels of editing were achieved in NHPs regardless of pre-existing or induced immunity to Staphylococcus aureus Cas9.

Broader ocular pipeline moving forward. Editas is pursuing product candidates for Usher Syndrome type 2A (USH2A) and recurrent ocular Herpes Simplex Virus type 1 (HSV-1). At the ASGCT (Free ASGCT Whitepaper) Meeting, Editas and collaborators from Massachusetts Eye and Ear presented in vitro data demonstrating that deletion of exon 13 in the human USH2A gene using CRISPR/Cas9 can restore cilia formation, providing the basis for a potential medicine. Editas also presented pre-clinical in vivo proof-of-concept data in a rabbit model for its recurrent ocular HSV-1 program at the Association for Research in Vision and Ophthalmology 2018 Annual Meeting.

Designing novel medicines for Sickle Cell Disease and Beta-Thalassemia. Editas reported data at the ASGCT (Free ASGCT Whitepaper) Meeting demonstrating that lead molecules targeting the beta-globin locus drove the upregulation of fetal hemoglobin in human mobilized peripheral blood stem cells. This was achieved by editing a novel genomic site that has potential to result in a best-in-class medicine. Editas expects to present additional data on this program in the second half of 2018.

Improving efficacy of engineered T cell medicines to treat cancer with CRISPR-based gene editing. In May, Editas expanded its collaboration with Juno Therapeutics, Inc., a Celgene company (Celgene), to develop and commercialize engineered T cell medicines for cancer. The recently expanded collaboration now encompasses four programs, including checkpoint inhibitors, tumor microenvironment, T cell receptor locus editing, and an undisclosed program.

Strong balance sheet to advance Company through multiple value inflection points. The Company held cash, cash equivalents, and marketable securities of $344.1 million as of June 30, 2018, providing at least 24 months of funding for operating expenses and capital expenditures without any assumption of future cash received from milestones or additional financings.

Upcoming Events

Editas will participate in the following investor conferences:

Citi 13th Annual Biotech Conference, Gene Editing Panel, September 5, 1:15 p.m. ET, Boston;
Morgan Stanley 16th Annual Global Healthcare Conference, Fireside Chat, September 12, 4:50 p.m. ET, New York City;
Jefferies Gene Therapy Summit, September 27, New York City; and
Chardan 2nd Annual Genetic Medicines Conference, October 9, New York City.
Editas will also participate in the following scientific and medical conferences:

26th Annual Congress of the European Society of Gene & Cell Therapy, October 16-19, Lausanne.

Second Quarter 2018 Financial Results

Cash, cash equivalents, and marketable securities at June 30, 2018, were $344.1 million, compared to $329.1 million at December 31, 2017.

For the second quarter ended June 30, 2018, net loss attributable to common stockholders was $38.7 million, or $0.82 per share, compared to $26.4 million, or $0.65 per share, for the same period in 2017.

Collaboration and other research and development revenues were $7.4 million for the quarter ended June 30, 2018, compared to $3.1 million for the same period in 2017. The $4.3 million increase was primarily attributable to $3.9 million in revenue recognized pursuant to a license agreement with Beam Therapeutics Inc. and a $2.8 million increase in revenue recognized pursuant to our collaboration agreement with Celgene, partially offset by a $2.4 million decrease in revenue recognized pursuant to our strategic alliance with Allergan.
Research and development expenses were $32.7 million for the quarter ended June 30, 2018, compared to $17.3 million for the same period in 2017. The $15.4 million increase was primarily attributable to $9.6 million in increased sublicensing and success payment expenses resulting from $12.5 million in research funding payments related to our sponsored research agreement with the Broad Institute which were partially offset by a decrease in sublicensing fees, $3.1 million in increased process and platform development expenses, $1.4 million in increased employee related expenses, $0.9 million in increased stock-based compensation expenses, and $0.4 million in increased facility-related expenses.
General and administrative expenses were $14.3 million for the quarter ended June 30, 2018, compared to $11.9 million for the same period in 2017. The $2.4 million increase was attributable to $1.1 million in increased stock-based compensation expenses, $0.7 million in increased employee related expenses, and $0.7 million in increased professional service expenses, partially offset by $0.2 million in decreased intellectual property and patent related fees.

Conference Call

The Editas management team will host a conference call and webcast today, August 6, 2018, at 5:00pm ET. To access the call, please dial 844-348-3801 (domestic) or 213-358-0955 (international) and provide the passcode 4379216. A live webcast of the call will be available on the Investors & Media section of the Editas Medicine website at www.editasmedicine.com and a replay will be available approximately two hours after its completion.