On July 18, 2022 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported the appointment of David Liu, M.D., Ph.D., as Chief Medical Officer and Kerry Wentworth as Chief Regulatory Officer (Press release, Nuvation Bio, JUL 18, 2022, View Source [SID1234616735]). Dr. Liu will lead Nuvation Bio’s clinical development team and collaborate with the executive committee to provide strategic direction for the Company’s research and drug development programs. Ms. Wentworth will oversee regulatory and quality affairs across the Company’s pipeline.

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"I am honored to join Nuvation Bio and oversee the clinical development of innovative therapies for the most difficult-to-treat cancers," said Dr. Liu. "I look forward to working with this experienced and dedicated team to address the unmet needs of cancer patients."

"Nuvation Bio’s mission to bring meaningful cancer treatments to patients who have nearly exhausted all options deeply resonates with me," said Ms. Wentworth. "The Company is taking on this bold challenge with tenacity and urgency, and I am proud to contribute to this important work."

Dr. Liu brings over 20 years of experience leading the discovery and development of oncology therapies, including New Drug Application (NDA) submissions for multiple oncology assets in the U.S., Europe, and China. Most recently, Dr. Liu served as the Chief Medical Officer at a biotechnology company based in Shanghai, China. There, he built and led their clinical research and development organization, including global clinical research, global clinical operations, pharmacovigilance, biostatistics, programming and data management, clinical pharmacology, and drug supply.

Ms. Wentworth has over 25 years of experience in domestic and international regulatory and quality affairs. Her background spans early and late development across multiple therapeutic areas, including oncology, osteoarthritis, pain management, autoimmune disorders, and rare diseases. She also has a broad scope of product knowledge, ranging from injectable small molecules to complex autologous platforms. Ms. Wentworth most recently served as Chief Regulatory Officer at Flexion Therapeutics, which was acquired by Pacira Biosciences in 2021, setting and delivering on regulatory and quality strategies across their product portfolio. Notably, Ms. Wentworth was instrumental in leading the company’s first NDA successfully into commercialization.

"We are pleased for David and Kerry to join the Nuvation Bio team and believe their decades of focused experience at leading global biopharmaceutical companies will significantly contribute to the development of our various programs," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We look forward to working with them as we aim to meaningfully improve the lives of cancer patients."

Earlier in his career, Dr. Liu held several roles of increasing strategic responsibility at Bristol Myers Squibb, where he became a leader in Oncology Global Clinical Research, including leading the Global Prostate Cancer Program, Pediatric Clinical Development, and Translational Research for ipilimumab, and development of nivolumab and ipilimumab for China. After Bristol Myers Squibb, Dr. Liu was the Global Lead Physician at Celgene for the revlimid plus rituximab submission program in indolent lymphoma. Dr. Liu earned a Ph.D. from the Massachusetts Institute of Technology, an M.S. from the University of Toledo, and an M.D. from Beijing Medical University (Peking University School of Medicine).

Prior to joining Flexion, Ms. Wentworth served as Vice President, Clinical, Regulatory, and Quality at Agenus, Inc., where she led all global regulatory and clinical development efforts. Previously, Ms. Wentworth led the regulatory and quality function for Genelabs Technologies, Inc., and prior to that held positions of increasing responsibility within Regulatory Affairs at Genzyme. Ms. Wentworth holds a B.S. in pre-veterinary medicine from the University of New Hampshire.

On July 18, 2022 Tiziana Life Sciences Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company enabling breakthrough immunotherapies via novel routes of drug delivery, reported that it has appointed Matthew Davis, MD, RPh as its Chief Medical Officer and Acting Chief Scientific Officer, effective immediately (Press release, Tiziana Life Sciences, JUL 18, 2022, View Source [SID1234616734]). Dr. Davis will report to Gabriele Cerrone, Executive Chairman and interim Chief Executive Officer of Tiziana.

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"Dr. Davis is a proven leader with 25 years in the pharmaceutical industry," said Gabriele Cerrone, Tiziana’s Executive Chairman and interim Chief Executive Officer. "We believe Dr. Davis’ experience with drug approvals is a key asset as the Company focuses more of its resources from discovery to proof-of-concept clinical trials. His broad therapeutic and FDA expertise, along with his in-depth experience with biologics will be invaluable as we pursue our mission to bring breakthrough therapies with the aim of treating Secondary-Progressive Multiple Sclerosis (SPMS), Crohn’s Disease and KRAS+ NSCLC and optimizing health outcomes."

"I am thrilled to join the Tiziana team, and for the opportunity to help advance Foralumab, TZLS-501 and Milciclib. I am energized to work with the passionate and dedicated R&D team and to meet the prestigious Scientific Advisors who are helping to guide the company," said Matthew W Davis, MD, RPh.

Dr. Davis has extensive experience in new drug application, or NDA, and biologic license application, or BLA, FDA approvals and device clearances. Notable approved brands that Dr. Davis has worked on include Lidoderm, Sculptra, Colcrys and most recently QWO.

Dr. Davis previously served as Chief Scientific Officer and Chief Medical Officer at Endo Pharmaceuticals where he restructured the R&D department and collaborated to obtain BLA approval for QWO. Additionally, Dr. Davis was Chief Medical Officer for Lupin Inc. and URL Pharma, Inc. where he spearheaded three NDA approvals and was the inventor on all 17 Orange Book listed patents for Colcrys. He also was on the executive team that sold URL Pharma to Takeda Pharmaceutical Company for approximately $800M combined with over $1B in performance-based contingent earn out payments.

Dr. Davis matriculated to the University of Pennsylvania as an undergraduate. He received his Pharmacy Degree from Temple University and his Medical Degree from the Medical College of Pennsylvania. Dr. Davis undertook his surgical training at Brown University and his Urology training at Washington Hospital Center.

On July 18, 2022 PharmaMar (MSE:PHM) reported that its partner in China, Luye Pharma Group Ltd., has obtained permission from the Hainan health authorities to open a compassionate use program for lurbinectedin for the treatment of Small Cell Lung Cancer ("SCLC") (Press release, PharmaMar, JUL 18, 2022, View Source [SID1234616733]).

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Lung cancer is a malignant tumor with high morbidity and mortality rates in China, and SCLC is an aggressive high-grade neuroendocrine carcinoma that accounts for 13%–17% of all lung cancer cases. According to the International Agency for Research on Cancer ("IARC"), lung cancer had higher morbidity and mortality rates than other malignant tumors in China in 2020, with 815,000 new lung cancer cases and 714,000 deaths reported that year. The IARC also predicted that in 2022 the number of new SCLC cases in China will exceed 110,000.

The opening of an Expanded Access Program for lurbinectedin to be used in Hainan means that Luye Pharma Group Ltd will be the first company to bring a new treatment option to SCLC patients in China who urgently need effective treatments.

In June 2020, lurbinectedin received "Accelerated Approval" from the FDA for the treatment of adult patients with metastatic SCLC with disease progression and is already the standard of care in the US. Lurbinectedin has also received marketing authorization in the United Arab Emirates, Canada, Australia and Singapore, and more recently in Qatar.

On July 18, 2022 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, JUL 18, 2022, View Source [SID1234616732]). This programme is part of the overall share repurchase programme of up to DKK 24 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 3 May 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 May 2022 to 2 August 2022.

Since the announcement 11 July 2022, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

Transactions related to Novo Nordisk’s incentive programmes have resulted in a net transfer from Novo Nordisk of 118 B shares in the period from 11 July 2022 to 15 July 2022. The shares in these transactions were not part of the Safe Harbour repurchase programme.

With the transactions stated above, Novo Nordisk owns a total of 16,586,351 B shares of DKK 0.20 as treasury shares, corresponding to 0.7% of the share capital. The total amount of A and B shares in the company is 2,280,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 24 billion during a 12- month period beginning 2 February 2022. As of 15 July 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 14,846,358 B shares at an average share price of DKK 761.55 per B share equal to a transaction value of DKK 11,306,189,864

On July 18, 2022 Invitae (NYSE: NVTA), a leading medical genetics company, reported a comprehensive plan to realize the full potential of its industry-leading genetics platform (Press release, Invitae, JUL 18, 2022, View Source [SID1234616731]). The plan introduces a significant realignment of the company’s operations in support of business lines and geographies that generate sustainable margins, provide the best return to fuel future investment and accelerate the company’s path to positive cash flow. The plan further helps ensure Invitae remains at the forefront of innovation and advancements in genomics by allocating resources towards the company’s core genome sequencing and genome management platforms that have the potential to improve healthcare outcomes.

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

The operational realignment includes streamlining and cost reduction programs that are expected to deliver approximately $326 million in annualized cost savings to be fully realized by 2023 and extend the company’s cash runway to the end of 2024.

In a separate press release issued earlier today, Invitae announced executive and board-level transitions to lead the company in this next phase and achieve its mission of bringing the power of genetic information to mainstream medicine.

Kenneth D. Knight, Invitae’s CEO, said, "We are at a unique, transitional moment in the rapidly-evolving genomics industry when companies that balance accessible, trusted and cutting-edge genomic information with disciplined operational excellence will be in a far stronger position to thrive and deliver transformative healthcare outcomes. This operational imperative is at the center of the plan we announced today, which will advance several critical objectives and is intended to drive long-term profitable growth. First, our refocused and realigned platform will allocate resources where they should be: at our core, we are a growth-oriented genomic testing platform. Second, aggressive actions to substantially reduce spend over the coming 12-18 months will improve operating leverage and align Invitae’s cost structure with current market dynamics and the broader economy. These adjustments will meaningfully extend our cash runway and accelerate the pursuit of our long-term growth targets and positive cash flow. Most importantly, the plan reaffirms our commitment to leading the way in shaping the future of medicine through powerful genomic tools."

Mr. Knight continued, "Invitae’s new operating plan has far-reaching and – for many of our dedicated, hard-working team members – difficult implications, and we regret that impact. Invitae is committed to working closely and compassionately with those adversely affected to help ensure as smooth a transition as possible, and we thank everyone on our team for their contributions. As we look to that future, we are as committed as ever to driving forward our mission and advancing the kind of transformative healthcare that is Invitae’s core."

Operating Plan Overview
At a high level, Invitae will eliminate non-core operations while realigning and sharpening its focus on the portfolio of businesses that generate sustainable margins and deliver returns to fuel future investment. In the testing business, Invitae will shift operational and commercial efforts to accelerate positive cash flow by maintaining robust support of the higher-margin, higher-growth testing opportunities among oncology, women’s health, rare disease and pharmacogenomics. The company also plans to continue its expansion and integration of key digital health-based technologies and services in order to create a differentiated model in genetic health. Longer-term, Invitae remains committed to its genomic management business. The company believes that it holds outsized growth potential and intends to continue to prioritize the tools, partnerships and applications that support the development of genome management as the catalyst for the future of healthcare.

Operating Plan Details
Headcount and office/lab space: The company plans workforce reductions aligned with its newly-streamlined operations. The company is also taking immediate steps to consolidate underutilized office and laboratory space.
Portfolio optimization: The company has conducted a rigorous assessment of its product portfolio as well as the associated research & development and commercial spending. The new plan shifts the focus to programs relevant to the core testing businesses to drive near-term cost of goods sold (COGS) reductions. These programs will speed the pathway to positive cash flow and drive the completion of the genome management platform that places Invitae in the middle of patients, providers and the greater healthcare ecosystem. Initiatives and products that are not attached to the go-forward core priorities have been put on hold or eliminated.
Other operating expenses: The company has performed an extensive review of internal and external costs and how those may align with the new business structure. Through that analysis, additional savings will be generated through the ongoing digitization of workflows, elimination of duplication and streamlined processes across the core platforms and rationalization of technology and external services spend.
International business structure: As part of the plan announced today, the company will shift its focus to serving less than a dozen international geographies where the testing business demonstrates the potential to reach positive cash flow in a shorter duration. The company plans to conduct an orderly exit from territories and countries in which the business is more nascent, focusing on supporting those territories through the transition and allowing those providers and patients sufficient time to shift to alternative resources for their testing needs.
As noted, these changes are expected to deliver approximately $326 million in annual cost savings by the end of 2023 and allow the company to extend its cash runway to the end of 2024. Invitae will operate as a leaner, more focused organization, targeting both a stronger and more profitable testing services business as well as the completion and launch of a genome management platform, which will serve to allow patients, providers, and the entire healthcare ecosystem to utilize genomic information for a lifetime of better personal health decisions and outcomes.

Supporting the growth of the company’s core testing and other commercial efforts remains a priority. The company will continue to drive its commercial efforts to best suit its differentiated platform offerings through a more efficient sales and marketing approach.

Preliminary Second Quarter Results
On a preliminary basis, the revenue for the quarter ended June 30, 2022 is approximately $136 million.

GAAP gross margin in the second quarter of 2022 is expected to be 18-19%. Non-GAAP gross margin is estimated to be 39-40%.

Cash, cash equivalents, restricted cash and marketable securities totaled around $737 million on June 30, 2022. Second quarter 2022 cash burn is estimated to be approximately $150 million.

Invitae has not completed preparation of its financial statements for the second quarter. The preliminary, unaudited results presented in this press release are based on current expectations and are subject to change. Actual results may differ materially from those disclosed in this press release.

Guidance
Invitae has updated its 2022 annual revenue guidance to reflect the preliminary first half results and the anticipated impacts of the actions announced today, which include the sale or wind down of non-core products and services and the elimination of certain international territories to focus on more profitable revenue streams. Revenue in the near term is anticipated to be flat in the second half of 2022 over the first half, representing a low double-digit growth rate for full year 2022 over 2021 despite the impacts of the strategic realignment. We expect 2023 to be an adjustment year and for longer term revenue growth rates to return to between 15% and 25% beyond 2023.

Invitae is maintaining its previous 2022 cash burn guidance of $600-650 million, which includes an estimated $75-100 million to be used for reorganization activities and severance. The company also anticipates its cash burn to be in the range of $225-275 million in 2023, or a $325-425 million reduction from expected 2022 cash burn.

Non-GAAP gross margins are expected to continue to increase for the rest of the year, based on ongoing margin improvement efforts and the current realignment initiatives, to the range of 42-43% for full year 2022.

Non-cash related charges are expected to be recorded in the third quarter of 2022 and in following quarters.

Webcast and Conference Call Details
Management will host a conference call and webcast today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss today’s announcements. To access the conference call, please register at the link below:

View Source DE684B93E9A64871E619579F0C45867A

Upon registering, each participant will be provided with call details and a conference ID.

The live webcast of the call and slide deck may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website.