On May 5, 2020 Genprex, Inc. ("Genprex" or the "Company") (Nasdaq: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, reported that it has entered into a Patent and Technology License Agreement ("License Agreement") with The University of Texas MD Anderson Cancer Center ("MD Anderson") in which MD Anderson granted to Genprex an exclusive worldwide license to a portfolio of 16 patent applications and related technology ("Licensed IP") for the treatment of cancer using Genprex’s lead drug candidate and TUSC2 gene therapy, known as "Oncoprex" or "GEN-001," in combination with immunotherapies (Press release, Genprex, MAY 5, 2020, View Source [SID1234557044]). This is a distinct therapeutic approach from that of combining Oncoprex with targeted therapies such as osimertinib (marketed as Tagrisso by AstraZeneca).

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Genprex was recently awarded U.S. FDA Fast Track designation for use of Oncoprex combined with Tagrisso for the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations whose tumors progressed after treatment with Tagrisso alone. The Company is now preparing to file an Investigational New Drug application to initiate a clinical trial of Oncoprex in combination with pembrolizumab (marketed as Keytruda by Merck) in NSCLC.

"We are pleased to advance the intellectual property that is covered by this License Agreement," said Rodney Varner, Genprex’s Chairman and Chief Executive Officer. "We are excited to be developing two distinct therapeutic approaches to lung cancer utilizing the combination of our gene therapy with successful targeted therapies, such as Tagrisso, and immunotherapies, such as Keytruda, to potentially improve patient outcomes and increase the number of patients who may benefit from these important therapies."

Immunotherapy or immunotherapy combined with chemotherapy is now the first-line standard of care for the majority of lung cancer patients. Published preclinical data indicate that when Oncoprex is combined with immunotherapies such as Keytruda, Oncoprex is synergistic with those drugs, meaning that the combination is more effective than either drug alone. The combination of Oncoprex and Keytruda may lead to better outcomes for many lung cancer patients.

The Licensed IP covers the use of Oncoprex in combination with one or more immunotherapies, including anti-PD1 antibodies, anti-PDL1 antibodies, anti-PDL2 antibodies, anti-CTLA-4 antibodies and/or anti-KIR antibodies for the treatment of cancer. These immunotherapies include pembrolizumab (Merck’s largest selling drug Keytruda), nivolumab (Bristol-Myers Squibb’s Opdivo), ipilimumab (Bristol-Myers Squibb’s Yervoy), and others. Use of chemotherapy in combination with Oncoprex and immunotherapy is also covered by the Licensed IP. While the initial disease indication for Oncoprex is NSCLC, the Licensed IP claims patent protection for combination use of Oncoprex in all types of cancers.

The License Agreement also provides for payment to MD Anderson of an up-front license fee and annual maintenance fees, with the potential for milestone payments, sublicensing fees, and product royalties.

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.

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.

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:

View Source

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.