Vericel Reports First Quarter 2020 Financial Results

On May 5, 2020 Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, reported financial results and business highlights for the first quarter ended March 31, 2020 (Press release, Vericel, MAY 5, 2020, View Source [SID1234557043]).

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First Quarter 2020 Financial Highlights

Total net product revenues increased 22% to $26.7 million, compared to $21.8 million in the first quarter of 2019, marking the twelfth consecutive quarter with record revenues for the reported quarter;

MACI net revenue of $20.3 million and Epicel net revenue of $6.4 million; the cancellation of scheduled MACI procedures late in the first quarter due to restrictions on elective surgical procedures reduced the volume of MACI implants for the quarter by approximately 9%;

Gross margin of 63%, compared to gross margin of 60% in the first quarter of 2019;

Net loss of $4.7 million, or $0.10 per share, compared to $2.8 million, or $0.07 per share, in the first quarter of 2019;

Non-GAAP adjusted EBITDA loss of $0.7 million, compared to $0.4 million in the first quarter of 2019;

Operating cash flow of $4.7 million; and

As of March 31, 2020, the company had $83.3 million in cash and investments, compared to $79.0 million as of December 31, 2019, and no debt.
Business Highlights and Updates

Implemented multiple measures in response to the COVID-19 pandemic to safeguard the health and well-being of employees, their families, business partners and healthcare providers, while continuing to supply MACI and Epicel to patients with knee cartilage and severe burn injuries;

Continued to provide field-based support for MACI and Epicel surgical cases, as needed, in compliance with applicable governmental orders and surgical facility policies and procedures;

Implemented the MACI sales force expansion from 49 to 76 sales territories and from six to nine sales regions;

Expanded utilization of virtual tools to support physician education initiatives in regions where executive orders or hospital policies restricted access;

Continued to actively work with surgeon offices and patients to move cases through the pipeline and reschedule or prepare to reschedule cancelled and postponed cases;

Implemented appropriate expense reduction measures, while maintaining workforce and operational readiness to rapidly return to normal operations when conditions allow; and

Continue to plan for a mid-2020 submission of the NexoBrid Biologics License Application to the FDA.
"The entire Vericel team would like to thank healthcare workers across the nation for their selfless efforts in the treatment and care of COVID-19 patients, and I would also like to thank all of our employees for their dedication and commitment to ensure that our customers and patients continue to have access to our products and clinical case support," said Nick Colangelo, President and CEO of Vericel. "I remain highly confident in the fundamental prospects for our business given the significant clinical need for both MACI and Epicel and, while uncertainties remain, we expect a robust return of MACI orders in regions where elective surgery restrictions are being lifted."
2020 Financial Guidance
As previously reported on April 2, 2020, due to the continued uncertainties resulting from the impact of the COVID-19 pandemic, the company has withdrawn its previously announced 2020 financial guidance.

First Quarter 2020 Results
Total net product revenues for the quarter ended March 31, 2020 increased 22% to $26.7 million, compared to $21.8 million in the first quarter of 2019. Total net product revenues for the quarter included $20.3 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $6.4 million of Epicel (cultured epidermal autografts) net revenue, compared to $16.6 million of MACI net revenue and $5.2 million of Epicel net revenue, respectively, in the first quarter of 2019.
Gross profit for the quarter ended March 31, 2020 was 16.8 million, or 63% of net revenues, compared to $13.2 million, or 60% of net revenues, for the first quarter of 2019.
Total operating expenses for the quarter ended March 31, 2020 were $21.8 million, compared to $16.5 million for the same period in 2019. The increase in operating expenses was primarily due

to a $1.3 million increase in MACI sales force expenses driven by the expansions in the first quarter of 2019 and 2020, a $0.9 million increase in stock based compensation expense, a $0.6 million increase in patient reimbursement support services, a $0.6 million increase in non-sales force related salaries and a $0.6 million increase in Epicel sales force expenses compared to the same period a year ago.
Vericel’s net loss for the quarter ended March 31, 2020 was $4.7 million, or $0.10 per share, compared to $2.8 million, or $0.07 per share, for the first quarter of 2019.
Non-GAAP adjusted EBITDA loss was $0.7 million for the quarter ended March 31, 2020, compared to $0.4 million in the first quarter of 2019. A table reconciling non-GAAP measures is included in this press release for reference.
As of March 31, 2020, the company had $83.3 million in cash and investments, compared to $79.0 million as of December 31, 2019, and no debt.
Conference Call Information
Today’s conference call will be available live at 8:30am Eastern Time and can be accessed through the Investor Relations section of the Vericel website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A slide presentation with highlights from 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 second-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 5, 2021. A replay of the call will also be available until 11:00am (EDT) on May 10, 2020 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 5906069.

CytomX Therapeutics to Present at the 2020 Bank of America Securities Health Care Conference

On May 5, 2020 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported that Sean McCarthy, D.Phil., president, chief executive officer and chairman, is scheduled to present at the virtual 2020 Bank of America Securities Health Care Conference (Press release, CytomX Therapeutics, MAY 5, 2020, View Source [SID1234557042]).

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Date: Thursday, May 14, 2020
Time: 11:40 a.m. Eastern Daylight Time
A live audio of this webcast will be available through the "Investors & News" section of CytomX’s website. An archived replay will be available for 60 days following the event.

DelMar Pharmaceuticals [Nasdaq:DMPI] Provides Enrollment Update in Phase 2 Clinical Trial of VAL-083 for Adjuvant Treatment of Brain Tumors

On May 5, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported it has enrolled 22 patients in the adjuvant arm of the Company’s ongoing Phase 2 clinical study investigating adjuvant treatment (pre-temozolomide — or TMZ — maintenance therapy) of MGMT-unmethylated glioblastoma multiforme (GBM) with VAL-083 (Press release, DelMar Pharmaceuticals, MAY 5, 2020, View Source [SID1234557041]).

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The adjuvant arm of the Phase 2 study of VAL-083 being conducted at the MD Anderson Cancer Center (MDACC) is designed to enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy. Additionally, in the recurrent arm of the study, which is also being conducted at MDACC, 72 patients out of a planned 83 patients have now been enrolled. DelMar continues to actively enroll patients in both trial arms of the clinical study, even in light of the COVID-19 pandemic.

DelMar previously announced that it had completed full enrollment of the planned 29 patients in its ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed, MGMT-unmethylated GBM. The trial is being conducted at the Sun Yat-sen University Cancer Center in Guangzhou, China, and is designed to determine whether first-line therapy with VAL-083 treatment improves progression free survival. The current standard of care is first line TMZ with radiation.

Pending meeting formats and other unforeseen changes, DelMar currently intends to announce additional clinical trial updates concomitant with planned scientific poster presentations at or around the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program May 29-31, 2020, and at or around the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II June 22-24, 2020.

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:

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Curis to Release First Quarter 2020 Financial Results and Hold Conference Call on May 12, 2020

On May 5, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the Company will release its first quarter 2020 financial results on Tuesday, May 12, 2020, after the close of US markets (Press release, Curis, MAY 5, 2020, View Source [SID1234557040]). Management will host a conference call on the same day at 4:30 p.m. ET.

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To access the live conference call, please dial (888) 346-6389 from the United States or (412) 317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the ‘Investors’ section. A replay of the financial results conference call will be available on the Curis website shortly after completion of the call.

Exicure to Present AST-008 Updates at 2020 AACR Virtual Annual Meeting

On May 5, 2020 Exicure, Inc. (NASDAQ: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that it will present at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, occurring June 22 – 24, 2020 (Press release, Exicure, MAY 5, 2020, View Source [SID1234557039]).

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The AACR (Free AACR Whitepaper) poster titled "Phase 1b/2 Study of an Intratumoral TLR9 Agonist Spherical Nucleic Acid (AST-008) and Pembrolizumab: Evidence of Immune Activation" will present updated pharmacodynamic and safety data of AST-008 alone and in combination with pembrolizumab from Exicure’s ongoing Phase 1b/2 study (ClinicalTrials.gov identifier: NCT03684785).

This poster will be presented during the AACR (Free AACR Whitepaper) Virtual Meeting II in the session Late-Breaking Research: Clinical Research 1 / Endocrinology under abstract number LB-140. The abstract will be available for viewing on May 15th and the poster will be available for viewing on June 22nd.

About AST-008

AST-008 is an SNA consisting of toll-like receptor 9 agonists designed for immuno-oncology applications. As of January 31, 2020, we have dosed 17 patients in the Phase 1b stage of the clinical trial. We have observed no treatment related serious adverse events, nor have we observed any dose-limiting toxicity among the treated subjects. The most common reported adverse event was injection site reactions. In December 2019, we received preliminary results from the Phase 1b/2 stage of the clinical trial showing potential signs of anti-tumor activity in patients with Merkel cell carcinoma. In the second quarter of 2020, we plan to initiate a Phase 2 dose expansion for intratumoral AST-008 in combination with approved checkpoint inhibitors to treat two cohorts of patients with advanced or metastatic Merkel cell carcinoma or cutaneous squamous cell carcinoma. Each cohort is expected to enroll up to 29 patients who have failed anti-PD-1/PD-L1, or programmed cell death protein 1/programmed death-ligand 1, therapy. We expect to open a total of up to 15 sites in the United States.