On May 7, 2019 Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, reported financial results for the first quarter ended March 31, 2019, and recent business highlights (Press release, Vericel, MAY 7, 2019, View Source [SID1234535836]).

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First Quarter 2019 Financial Highlights

Total net product revenues increased 21% to $21.8 million compared to $18.0 million in the first quarter of 2018;

Gross margins of 60% compared to gross margins of 57% in the first quarter of 2018;

Net loss of $2.8 million, or $0.07 per share, compared to $7.7 million, or $0.21 per share, in the first quarter of 2018;

Non-GAAP adjusted EBITDA loss of $0.4 million compared to a loss of $2.6 million in the first quarter of 2018;

As of March 31, 2019, the company had $84.1 million in cash and short-term investments compared to $82.9 million as of December 31, 2018; and

Full year 2019 revenue guidance for MACI and Epicel raised to $110 to $114 million compared to previous full year revenue guidance of $108 million to $112 million.

Recent Business Highlights
During and since the first quarter of 2019, the company:

Announced an exclusive license agreement with MediWound Ltd. for North American rights to NexoBrid, a biological orphan product for debridement of thermal burns;

Deployed the expanded MACI sales force, which increased from 40 to 48 territories; and

Reported publication of outcomes data from 954 burn patients treated with Epicel in the Journal of Burn Care and Research.

"We delivered another solid quarter of performance and the MACI sales force continues to increase its productivity even as we add new representatives, which speaks to the quality of our sales representatives as well as the demand for MACI," said Nick Colangelo, president and CEO of Vericel. "Based on the strong underlying indicators of growth for the rest of the year we have raised our full year 2019 revenue guidance. Moreover, we believe that the addition of NexoBrid significantly expands our burn care target addressable market and will enable us to build a second significant commercial franchise to go along with our cartilage repair franchise, thereby enhancing the long-term growth profile of the company."

First Quarter 2019 Results
Total net product revenues for the quarter ended March 31, 2019 increased 21% to $21.8 million compared to $18.0 million in the first quarter of 2018. Total net product revenues for the quarter included $16.6 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $5.2 million of Epicel (cultured epidermal autografts) net revenue, compared to $12.1 million of MACI net revenue and $6.0 million of Epicel net revenue, respectively, in the first quarter of 2018.
Gross profit for the quarter ended March 31, 2019 was $13.2 million, or 60% of net revenues, compared to $10.4 million, or 57% of net revenues, for the first quarter of 2018.
Total operating expenses for the quarter ended March 31, 2019 were $16.5 million compared to $14.7 million for the same period in 2018. The increase in operating expenses was primarily due to a $1.2 million increase in stock-based compensation, an incremental $0.6 million in MACI sales force expenses as a result of the sales force expansion in the second quarter of 2018, and a $0.6 million increase in selling expenses and patient reimbursement support services.
Vericel’s net loss for the quarter ended March 31, 2019 was $2.8 million, or $0.07 per share, compared to $7.7 million, or $0.21 per share, for the first quarter of 2018.
Non-GAAP adjusted EBITDA loss was $0.4 million for the quarter ended March 31, 2019 compared to a loss of $2.6 million in the first quarter of 2018. See table reconciling non-GAAP measures for more details.
As of March 31, 2019, the company had $84.1 million in cash and short-term investments compared to $82.9 million as of December 31, 2018.
Full Year 2019 Financial Guidance
The company now expects total MACI and Epicel net product revenues for the full year 2019 to be in the range of $110 to $114 million, compared to the previous full year revenue guidance of $108 to $112 million.

Conference Call Information
Today’s conference call will be available live at 8:00am Eastern time in the Investor Relations section of the Vericel website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A presentation supporting today’s conference call will be available on the webcast and in the Investor Relations section of the Vericel website. 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 first-quarter 2019 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 May 7, 2020. A replay of the call will also be available until 11:00am (EDT) on May 12, 2019 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 1775796.

On May 7, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported the online publication of a new manuscript, Discovery and Characterization of SY-1365, a Selective, Covalent Inhibitor of CDK7, in the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s (AACR) (Free AACR Whitepaper) journal, Cancer Research (Press release, Syros Pharmaceuticals, MAY 7, 2019, View Source [SID1234535853]). SY-1365, a first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, is currently being investigated in a Phase 1 clinical trial as a single agent and in combination with standard-of-care therapies in multiple ovarian and breast cancer patient populations that lack effective treatment options. This publication highlights the discovery, mechanism of action and promise of SY-1365 as a new targeted approach for a range of difficult-to-treat cancers.

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"SY-1365 represents a potentially transformative targeted approach for a number of cancers that have eluded treatment with existing approaches," said Eric R. Olson, Ph.D., Syros’ Chief Scientific Officer. "While CDK7 has long been a target of interest, it was historically difficult-to-drug. This new publication profiles our work in discovering SY-1365, which we believe to be the most advanced selective CDK7 inhibitor in clinical development, and the substantial anti-tumor activity seen in preclinical models that supported its advancement into the clinic. We are excited by the promise of CDK7 inhibition and the potential benefit SY-1365 may bring to patients who are in dire need of better therapies."

Syros is currently conducting a Phase 1 clinical trial assessing the safety and efficacy of SY-1365 as a single agent and in combination with standard-of-care therapies in multiple ovarian and breast cancer patient populations. The trial includes cohorts evaluating SY-1365 as a single agent in patients with relapsed ovarian clear cell cancer and in high-grade serous ovarian cancer (HGSOC) patients who have had three or more prior lines of therapy; in combination with carboplatin in HGSOC patients who have had one or more prior lines of therapy; in combination with fulvestrant in metastatic hormone receptor-positive breast cancer patients who are resistant to treatment with a CDK4/6 inhibitor; and as a single agent in patients with solid tumors of any histology accessible for biopsy. Additional details about the trial can be found using the identifier NCT03134638 at www.clinicaltrials.gov.

CDK7 plays a key role in the transcription of genes and in cell cycle regulation, and inhibiting CDK7 disrupts two important processes that cancer cells use to survive: 1) expression of cancer-promoting genes; and 2) uncontrolled cell cycle progression. SY-1365 has shown anti-tumor activity in preclinical models of a range of solid tumors and blood cancers, including cancers that have become resistant to treatment with existing therapies or where existing options have failed to provide meaningful benefit to patients. Further, data suggests that SY-1365 works to inhibit the growth of cell lines representing many different cancer types at nanomolar concentrations, decreases MCL1 protein levels, and demonstrates activity among cancer cells with low BCL-XL expression.

Building on its leadership in CDK7 inhibition, Syros is advancing SY-5609, a highly selective and potent oral CDK7 inhibitor, toward clinical development. In preclinical studies, SY-5609 has demonstrated substantial anti-tumor activity, including inducing complete regressions in cell line-derived xenograft models of breast and ovarian cancers. The company plans to complete investigational new drug application (IND)-enabling studies by the end of 2019 to support the initiation of a Phase 1 oncology trial in early 2020.

On May 7, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported first quarter 2019 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, MAY 7, 2019, View Source;p=RssLanding&cat=news&id=2397573 [SID1234535881]).

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"We have made great progress in recent months in advancing TIL therapy toward commercialization. In April, we dosed the first patient in the pivotal study, Cohort 4 of the innovaTIL-01 melanoma trial, bringing us a step closer to our goal of filing for regulatory approval of lifileucel in 2020," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "We are pleased that three Iovance abstracts submitted to ASCO (Free ASCO Whitepaper) have been accepted, two of which include data updates from our fully enrolled Cohort 2 of our melanoma program and data from our ongoing LN-145 cervical study being presented for the first time in a medical conference at the 2019 meeting."

Recent Achievements and Upcoming Milestones

Clinical

In April 2019, the company announced that the first patient was dosed in Cohort 4 of the pivotal innovaTIL-01 study of lifileucel in metastatic melanoma.
New interim data from Cohort 2 of the innovaTIL-01 melanoma study and data from the ongoing innovaTIL-04 cervical cancer study will be presented on June 1, 2019 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.
The company closed the IOV-LUN-201 study and instead will add an additional arm to the IOV-COM-202 study, adapting clinical development plans to reflect advances in the treatment landscape for non-small cell lung cancer.
The protocol for innovaTIL-04, the Phase 2 study in cervical cancer, was amended to increase the sample size to 59 and to modify the primary endpoint of Objective Response Rate (ORR) to be determined by a Blinded Independent Review Committee (BIRC). The company made the changes in anticipation of a meeting with the U.S. Food and Drug Administration (FDA) planned for later this year to discuss the registration pathway for LN-145 in cervical cancer.
Regulatory

In February 2019, LN-145 received Fast Track designation from the FDA for the cervical cancer indication.
Research

In April 2019, persistence and biomarker data from Cohort 2 of the innovaTIL-01 study of lifileucel in the treatment of advanced melanoma were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. The presentation described results of an analysis of circulating T cells at 42 days post-infusion, highlighting the uniqueness of clonal profiles in TIL therapy in melanoma. The results support potential use of a polyclonal product such as Iovance bulk TIL in the treatment of melanoma and likely other cancers with high mutational load solid tumors.
Researchers at Iovance have generated data in collaboration with Roswell Park Cancer Center from the 22-day Gen 2 process of generating TIL from patient derived bladder cancer tumor tissue. An abstract describing the data has been accepted for presentation at the upcoming AACR (Free AACR Whitepaper) "Bladder Cancer: Transforming the Field" conference taking place May 18-21, 2019.
Corporate

In May 2019, the company opened a satellite office in Philadelphia, Pennsylvania. The office will house various functions including members of the Iovance legal and manufacturing teams.
First Quarter 2019 Financial Results

Net loss for the quarter ended March 31, 2019 was $37.0 million, or $0.30 per share, compared to net loss of $26.5 million, or $0.31 per share for the quarter ended March 31, 2018.

Research and development expenses were $30.9 million for the quarter ended March 31, 2019, an increase of $11.0 million, compared to $19.9 million for the same period ended March 31, 2018. The increase in research and development expenses was primarily attributable to an increase in the total number of patients in our clinical studies which in turn results in higher manufacturing and clinical study costs, technology transfer expenses and an increase in research and development headcount.

General and administrative expenses were $9.1 million for the quarter ended March 31, 2019, an increase of $2.1 million compared to $7.0 million for the same period ended March 31, 2018. The increase was primarily attributable to an increase in general and administrative headcount and higher stock based compensation.

Cash, Cash Equivalents and Short-term Investments

At March 31, 2019, the company held $440.0 million in cash, cash equivalents, and short-term investments compared to $468.5 million at December 31, 2018.

Webcast and Conference Call

Iovance will host a conference call and live audio webcast to discuss financial results and provide a corporate update today at 4:30 p.m. EDT.

To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 7393657. The live webcast can be accessed under "News & Events: Investor Calendar" in the Investors section of the Company’s website at www.iovance.com or at the link: View Source An archived webcast will be available in the Investors section of www.iovance.com for thirty days following the call.

On May 7, 2019 GeneQuantum Healthcare reported that it has closed nearly RMB 100 million Pre-B round of financing (Press release, GeneQuantum Healthcare, MAY 7, 2019, View Source [SID1234553994]). This financing was led by Huagai Capital, joined by Hofon Capital and Changjinboya. GeneQuantum Healthcare’s A-round investor Oriza Seed and TF Capital continued for additional investments. The funds raised in this round are mainly used to promote the global clinical development of next generation of ADCs, as well as the rapid development and layout of a series of differentiated innovative technologies and products.

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GeneQuantum Healthcare focuses on the research and development of various innovative bioconjugate drugs via its innovative LDC technology and the international first-class iLDC platform. The company’s iLDC platform utilizes an enzyme-catalyzed intelligent continuous conjugation process, which has successfully achieved pilot production for next generation of highly homogeneous ADCs with significantly improved quality and reduced costs. The platform process revolutionizes the existing chemical conjugation based production mode and can be widely applied to the automated manufacturing of various bioconjugate drugs represented by ADC drugs. Taking advantage of this platform, GeneQuantum Healthcare has established cooperation with pharmaceutical companies regarding innovative bioconjugate drug research and development.

Dr. Gang Qin, Chairman and President of GeneQuantum Healthcare, said: "GeneQuantum’s innovative ADC is about to initiate clinical trial and the pipeline is rapidly expanding. We are thrilled to be recognized and supported by the leading investors such as Huagai Capital and others at this time point. We look forward to working with investors to expedite our business growth in highly differentiated innovative products, to further expand the application of iLDC platform, and to enhance our unique advantages in precision diagnosis and treatment of tumors, so as to provide innovative treatment plan for cancer patients worldwide. With our advantages in intelligent continuous conjugation platform, we will cooperate with international and domestic pharmaceutical companies to rapidly promote more and better bioconjugate drug development and industrialization."

Mr. Zhiqiang Zeng, the managing partner of Huagai Capital, said: "GeneQuantum is a first class enzymatic-conjugation ADC company in the world. It has independently developed its unique iLDC platform and is capable of growing into an internationally competitive biopharmaceutical leader. The next generation of ADCs developed by GeneQuantum Healthcare will help more patients in the future."

Mr. Qun Zhao, partner of Oriza Seed, said: "We are very optimistic about the potential of enzymatic conjugation technology in the field of ADCs. GeneQuantum Healthcare comprises vast technical accumulation and innovative reserves. We’ll expect the release of GeneQuantum Healthcare’s products to benefit patients as soon as possible."

On May 7, 2019 Medivir AB (Nasdaq Stockholm: MVIR) reported that data from the investigator-initiated study evaluating the effects of remetinostat in basal cell carcinoma patients, will be presented during the 2019 Society for Investigative Dermatology (SID) annual meeting in Chicago, USA (Press release, Medivir, MAY 7, 2019, View Source [SID1234535776]).

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Data will be presented on a poster and orally on May 10 and 11, respectively. The title of the abstract is: "An Open-Label Phase 2 Clinical Trial of Topical Remetinostat Gel for Basal Cell Carcinoma".

Authors: Nicole Urman B.S., Shaundra Eichstadt M.D., Hanh Do B.S., Amar Mirza B.S., Irene Bailey Ph.D., Shufeng Li Ph.D., Stanley T. Hollmig, Jean Y. Tang M.D. Ph.D., Anthony E. Oro M.D. Ph.D., Sumaira Aasi M.D., and Kavita Y. Sarin M.D. Ph.D.

Details of all presentations for the 2019 SID annual meeting are available at the conference website:View Source

For further information, please contact:
Uli Hacksell, CEO, Medivir AB, phone: +46(0)73-125-0615