On August 10, 2020 Maryland has become a key part of the strategy for Kite, a Gilead company, and its mission to find a cure for cancer (Press release, Kite Pharma, AUG 10, 2020, View Source [SID1234563629]). As the California-based company focuses more and more on cutting-edge cell therapy research and manufacturing, Kite is expanding its toehold in the BioSpace Hotbed region known as BioCapital.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Kite first moved into Maryland in 2018 following the forging of a cell therapy-focused partnership with the National Cancer Institute to develop adoptive cell therapies targeting patient-specific tumor neoantigens, which are mutations found on the surface of cancer cells that are unique to each person and tumor.

Kite announced it leased a 26,000 square-foot facility in Gaithersburg, Maryland, which is just miles away from Bethesda, Maryland, home of the NCI. The Gaithersburg site is focused on research and clinical manufacturing of TCR-based, adoptive t-cell therapies for solid tumor cancers.

After two years, Kite has more than 60 employees in its Gaithersburg facility. More employees will be needed at the facility as Kite invests more money to expand the facility to support the solid tumor research.

Matthew Levy, Associate Director, Talent Acquisition with Kite told BioSpace in an interview that the work being accomplished at the Gaithersburg facility is exciting due to the cutting-edge technology. As the facility expands, Levy said Kite will continue to hire the best and brightest to help the company in its mission of curing cancer.

With Maryland’s rich life sciences ecosystem, one that includes multiple government agencies like NCI, the National Institutes of Health and the U.S. Food and Drug Administration, Levy said Kite will be able to draw on a highly skilled talent pool as it expands its headcount in Gaithersburg. Not only does Maryland have a strong pool of talent already in place, Levy said the state is a nice place to live and offers residents a lot of cultural and recreational amenities. Although Kite has not identified a target number of employees it will hire for the Gaithersburg site, Levy said the company is already hiring for a number of positions there and will be expanding further next year.

Gaithersburg isn’t the only site Kite has in the state of Maryland. In 2019, the company announced it will build a third cell therapy manufacturing facility to support the company’s CAR-T manufacturing needs. Kite selected Frederick, Maryland in addition to its two other facilities in California and The Netherlands. "This will enable us to meet the future needs for cell therapies," Levy said.

Following the FDA-approval of Yescarta, its CAR-T treatment for some blood cancers, Levy said the company realized that having additional capacity in manufacturing would be beneficial for the cutting-edge treatment. Logistically, Levy said it was beneficial to have a manufacturing facility on the East Coast of the United States. He noted that the individualized CAR-T treatment cannot be stockpiled like some other medications can and having the third facility better serves Kite’s patients.

In addition to the manufacture of Yescarta, which was approved in 2017 two months after Kite was acquired by Gilead Sciences for $12 billion, the Maryland facility will also be ready to produce future commercial cell therapies.

"We’re sparing no expense to bring the best science to bear for patients," Levy said.

The 280,000 square-foot Frederick facility is expected to come online in 2022. The site is expected to employ a few hundred people over the next several years and Levy said the company is actively recruiting for positions there. Types of positions the company is recruiting for include manufacturing, facilities and engineering, supply chain and quality.

When it comes to potential candidates, Levy said the company is looking for candidates who are patient-centric in their work. Ideal candidates will be passionate about using their technical skills to benefit cancer patients. Levy stressed a strong sense of connectivity between the work performed at Kite and the patients the company serves. For example, Cell Therapy Specialists – Kite’s manufacturing technicians – literally hold patients’ cells in their hands; that personalized approach drives home the point that patients are at the center of everything the company does, Levy noted.

"If someone is looking for an opportunity to positively impact cancer patients through cutting-edge work in cell therapy, Kite is a great place to be," Levy said. "We really mean it when we say that cancer is personal to us."

On August 10, 2020 Spark Therapeutics, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and a fully integrated, commercial gene therapy company dedicated to challenging the inevitability of genetic disease, reported the appointment of Gallia Levy, M.D., Ph.D., as chief medical officer (Press release, Sparx Therapeutics, AUG 10, 2020, View Source [SID1234563389]). Dr. Levy will be responsible for strategic and operational leadership across all functions in the product development lifecycle, including setting the global development strategy for current and future pipeline programs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are thrilled to welcome Dr. Gallia Levy to our growing gene therapy company striving to create a world where no life is limited by genetic disease," said Jeffrey D. Marrazzo, chief executive officer, Spark Therapeutics. "Dr. Levy’s passion for hematology and gene therapy research are immediately evident and is exactly the perspective needed to achieve our goal of unlocking the full potential of gene therapy. Especially during this pivotal time in hemophilia research, Dr Levy’s deep understanding of rare blood disorders and the community will help accelerate our ability to deliver potentially transformative gene therapies for hemophilia, while progressing potential gene therapies for other genetic disease across our pipeline."

Dr. Levy joins Spark Therapeutics from Genentech, a member of the Roche Group, where she served as the Vice President and Global Head of the Rare Blood Disorders franchise in Product Development. In this role, she was responsible for the clinical development of HEMLIBRA for hemophilia A as well as treatments for other rare blood disorders such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). She has played a key role in the evolution of gene therapy as a new modality within the Roche group.

"I’ve spent my career working to find new, innovative treatment approaches for patients affected by rare, life-altering disorders, and it is with great pride that I join the Spark team to help advance novel gene therapy programs and create next-generation solutions for patients," said Dr. Levy. "Spark Therapeutics shares the same affinity for breaking barriers and putting the patient first, and I look forward to what we will achieve together."

Dr. Levy first joined Genentech in 2009, where she worked in both early and late-stage clinical development. She later moved to Portola Pharmaceuticals, where she led the clinical development program for hematology and oncology indications, and returned to Genentech in 2014 to lead the hemophilia program.

Dr. Levy is board-certified in hematology and holds an M.D. and Ph.D. in Molecular and Cellular Biology from the University of Michigan. She completed her residency in internal medicine at Stanford University and a fellowship in hematology and oncology at the University of California, San Francisco. She also holds an M.S. in of Molecular and Cellular Biology from the University of Paris, VI and a B.A. from the University of California, Berkeley.

On August 10, 2020 RhoVac reported that the first patient in the USA is included in clinical phase IIb study, called BRaVac (Press release, RhoVac, AUG 10, 2020, View Source [SID1234563381]). The first US clinic to include a patient in the study was Carolina Urologic Research Center. BraVac is a randomized, placebo controlled and double-blind study, with the primary objective of evaluating if treatment with the drug candidate RV001 can prevent or limit the development of advanced prostate cancer after curative intent treatment. BRaVac is an international, multi-centre study, which will recruit over 175 patients in six European countries (Denmark, Finland, Germany, Belgium, Sweden, and the UK) plus the USA. The study has already commenced in Denmark, Finland, Germany, Belgium and now in the USA. RhoVac anticipates recruitment to start very soon also in Sweden and the UK, and the company expects the phase IIb recruitment to be complete by end 2020, and the trial to conclude end 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Anders Månsson, CEO, comments: "We have truly reached a great milestone in now recruiting patients also in the USA, which is the largest and most important market in the world for our drug candidate RV001. I am very happy and proud that we have been able to keep our important clinical phase IIb trial going, and that more and more countries are joining the study, despite the impact of the pandemic."

On August 10, 2020 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, reported the closing of an underwritten public offering of 5,750,000 shares of its common stock at a public offering price of $18.00 per share, which includes the exercise in full by the underwriters of their option to purchase an additional 750,000 shares (Press release, Immunic, AUG 10, 2020, View Source [SID1234563380]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Immunic received total proceeds from the offering, before deducting the underwriting discounts and other offering expenses, of $103.5 million.

SVB Leerink acted as sole bookrunning manager for the offering. Wedbush PacGrow and Ladenburg Thalmann acted as co-managers for the offering.

The Company intends to use the net proceeds of the offering to fund the ongoing clinical development of its three lead product candidates, IMU-838, IMU-935 and IMU-856, including to investigate IMU-838 in a potential phase 3 program in relapsing-remitting multiple sclerosis, and for other general corporate purposes.

The securities described above were offered by Immunic, Inc. pursuant to a shelf registration statement filed by Immunic, Inc. with the Securities and Exchange Commission (SEC), which was declared effective on June 13, 2018. A final prospectus supplement and accompanying prospectus related to the offering was filed with the SEC on August 5, 2020 and is available for free on the SEC’s website at www.sec.gov.

Copies of the final prospectus supplement and the accompanying prospectus related to the offering may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by email at [email protected], or by telephone at (800) 808-7525, ext. 6218.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On August 10, 2020 Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI); (OTCQX:NRIFF), a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products, reported its financial and operational results for the three and six months ended June 30, 2020 (Press release, Nuvo Pharmaceuticals, AUG 10, 2020, View Source [SID1234563379]). For further details on the results, please refer to Nuvo’s Management, Discussion and Analysis (MD&A) and Condensed Consolidated Interim Financial Statements for the three and six months ended June 30, 2020 which are available on the Company’s website (www.nuvopharmaceuticals.com). All figures are in Canadian dollars, unless otherwise noted.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Key Developments

Three months ended June 30, 2020 include the following:

For the three months ended June 30, 2020, adjusted total revenue(1) was $18.0 million, a decrease of 6% compared to $19.1 million for the three months ended June 30, 2019.
For the three months ended June 30, 2020, adjusted EBITDA(1) was $7.6 million, an increase of 33% compared to $5.7 million for the three months ended June 30, 2019.
The Company’s Commercial Business segment includes the promoted products – Blexten and Cambia . Revenue related to these products was $6.3 million, an increase of 14% compared to revenue of $5.5 million for the three months ended June 30, 2019. Canadian prescriptions of Blexten and Cambia increased by 34% and 11%, respectively compared to the three months ended June 30, 2019.
Principal loan repayments of $3.5 million (US$2.5 million) were made in the three months ended June 30, 2020.
Six months ended June 30, 2020 include the following:

For the six months ended June 30, 2020, adjusted total revenue(1) was $37.0 million, an increase of 2% compared to $36.2 million for the six months ended June 30, 2019.
For the six months ended June 30, 2020, adjusted EBITDA(1) was $15.6 million, an increase of 43% compared to $10.9 million for the six months ended June 30, 2019.
Revenue related to Cambia and Blexten was $12.2 million, an increase of 42% compared to revenue of $8.6 million for the six months ended June 30, 2019. Canadian prescriptions of Blexten and Cambia increased by 41% and 20%, respectively compared to the six months ended June 30, 2019.
Principal loan repayments of $15.1 million (US$11.2 million) were made in the six months ended June 30, 2020.

(1)

Non-International Financial Reporting Standards (IFRS) financial measure defined by the Company below.

Business Update

As a result of the COVID-19 pandemic, the Company has made changes to operations to ensure our employees are safe and healthy, while the business continues to supply global partners, wholesalers, pharmacies, and ultimately patients, with our healthcare products. The Commercial Business segment saw continued organic growth of its key promoted products – Blexten and Cambia. Aggregate revenue declined in the quarter year-over-year as wholesaler and pharmacy demand normalized from the increase which occurred in the three months ended March 31, 2020. The possibility of future supply disruptions resulted in forward buying linked to the COVID-19 pandemic which increased revenue in the three months ended March 31, 2020 and reduced revenue in the three months ended June 30, 2020 as the pandemic progressed and buying patterns returned to normal. It is anticipated that the COVID-19 pandemic will continue to impact the timing of revenue in future quarters and the Company will monitor market dynamics accordingly.
In June 2020, Aralez Pharmaceuticals Canada Inc. (Aralez Canada) filed the Blexten pediatric dossier with Health Canada. A regulatory decision is anticipated by mid-2021. The original license agreement for Blexten included Canadian rights for the pediatric dosage formats. Blexten pediatric dosing consists of two new formats, an oral syrup formulation (2.5mg/ml) and an orally dispersible tablet formulation (10mg tablets).
During the three months ended June 30, 2020, the Company made a $3.5 million (US$2.5 million) principal repayment on loans held by Deerfield Management Company, L.P and its related entities (the Deerfield Loans). Since January 1, 2020, the Company has repaid $15.1 million (US$11.2 million) of the Deerfield Loans – $4.5 million (US$3.5 million) to discharge the Bridge Loan which bore interest at 12.5% and $10.5 million (US$7.7 million) against the Amortization Loan which bears interest at 3.5%. As of June 30, 2020, the total remaining balances of the Deerfield Loans consisted of: US$52.3 million on the Amortization Loan and US$52.5 million on the Convertible Loan.
"Year-to-date, our key products have performed well, despite the challenges presented by the COVID-19 pandemic. Cambia and Blexten both continue to grow market share and total prescription volume. We are looking to expand the Blexten portfolio with two new formats for children with the submission of the Blexten pediatric dossier to Health Canada in June," said Jesse Ledger, Nuvo’s President & CEO. "Our total adjusted revenue for the first six months increased compared to the same period last year, in spite of the challenges we encountered with the reduction in our U.S. Vimovo royalty stream during the first six months of this year. We continue to reduce our financial leverage by making significant payments on our Deerfield Loans. Looking ahead, we are excited about our continued growth that includes the anticipated commercial launch of Suvexx into the Canadian market in September."

Second Quarter 2020 Financial Results
Total revenue is comprised of product sales, license revenue and contract revenue. Total revenue was $15.5 million and $39.9 million for the three and six months ended June 30, 2020 compared to $16.6 million and $31.1 million for the three and six months ended June 30, 2019.

Adjusted total revenue was $18.0 million and $37.0 million for the three and six months ended June 30, 2020 compared to $19.1 million and $36.2 million for the three and six months ended June 30, 2019. The $1.1 million decrease in adjusted total revenue in the current quarter was primarily attributable to a decrease of $1.2 million of revenue in the Production and Service Business segment, combined with a $0.5 million decrease from the Commercial Business segment, partially offset by a $0.6 million increase in the Licensing and Royalty Business segment. The Commercial Business segment revenue saw continued organic growth of its key promoted products – Blexten and Cambia. Aggregate revenue declined in the quarter year-over-year as wholesaler and pharmacy demand normalized from the increase which occurred in the three months ended March 31, 2020.

Adjusted EBITDA increased to $7.6 million and $15.6 million for the three and six months ended June 30, 2020 compared to $5.7 million and $10.9 million for the three and six months ended June 30, 2019. The increase in the current quarter was primarily attributable to the decrease of $2.6 million in general and administrative (G&A) expenses and sales and marketing expenses (net of amortization), largely as a result of the Company’s June 2019 restructuring. This was partially offset by a decrease in gross profit of $0.7 million (net of revenue recognized upon recognition of contract assets, amounts billed to customers for existing contract assets and inventory-step up expenses). This decline in gross profit was due to a decrease in adjusted total revenue, partially offset by an increase in gross margin percentage on product sales.

Gross profit on total revenue was $10.0 million or 64% and $28.9 million or 72% for the three and six months ended June 30, 2020 compared to a gross profit of $9.6 million or 58% and $18.7 million or 60% for the three and six months ended June 30, 2019. The increase in gross profit for the current three and six-month periods was primarily attributable to an increase in license revenue and gross margin on product sales.

Non-IFRS Financial Measures
The Company discloses non-IFRS measures (such as adjusted total revenue, adjusted EBITDA and adjusted EBITDA per share) that do not have standardized meanings prescribed by IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding the Company’s financial performance and in interpreting the effect of the Aralez Transaction and the Deerfield Financing on the Company. Non-IFRS financial measures do not have any standardized meaning prescribed by IFRS and may not have been calculated in the same way as similarly named financial measures presented by other companies.

Adjusted EBITDA
EBITDA refers to net income (loss) determined in accordance with IFRS, before depreciation and amortization, net interest expense (income) and income tax expense (recovery). The Company defines adjusted EBITDA as net income before net interest expense (income), depreciation and amortization and income tax expense (recovery) (EBITDA), plus amounts billed to customers for existing contract assets, inventory step-up expenses, stock-based compensation expense, Other Expenses (Income), less revenue recognized upon recognition of a contract asset and other income. Management believes adjusted EBITDA is a useful supplemental measure to determine the Company’s ability to generate cash available for working capital, capital expenditures, debt repayments, interest expense and income taxes.

Management to Host Conference Call/Webcast
Management will host a conference call to discuss the results today (Monday, August 10, 2020) at 8:30 a.m. ET. To participate in the conference call, please dial 416 764 8688 or 1 888 390 0546. Please call in 15 minutes prior to the call to secure a line. You will be put on hold until the conference call begins.

A taped replay of the conference call will be available two hours after the live conference call and will be accessible until midnight on August 17, 2020 by calling 416 764 8677 or 1 888 390 0541 / replay passcode: 492164#.

A live audio webcast of the conference call will be available through www.nuvopharmaceuticals.com. Please connect at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to hear the webcast.