On March 24, 2020 Laekna Therapeutics Shanghai Co., Ltd. (Laekna) reported a new agreement with Novartis giving the China-based biotech company exclusive global rights to Novartis’ anti-PD-L1 Antibody (FAZ053).

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FAZ053 has been involved in a phase I clinical trial in patients with advanced cancer. The trial demonstrated positive proof-of-concept results for a tolerable safety profile and clinical efficacy of FAZ053 in diverse solid tumors. Laekna, a company dedicated to the research and development of small-molecule and antibody-targeted drugs, now has exclusive rights to develop and commercialize the PD-L1 oncology asset. With this move, the company aims to advance clinical research and introduce pioneering new drugs to patients, including the rapidly growing cancer patient population in China.

"A combination of PD-L1 Antibody with chemotherapy, or targeted therapy can greatly improve treatment response and prolong survival," said Dr. Yong Yue, CMO of Laekna. "We have mapped a number of combination strategies to treat a variety of cancers that do not respond or are resistant to checkpoint inhibitor treatments."

Laekna plans to start trials on combination therapies as soon as possible in order to address the unmet needs of people with cancer and bring innovative, effective treatments to more cancer patients across China.

This is the third in a recent series of agreements between Laekna and Novartis. "Novartis is a global leader in oncology drug innovation and we believe that the three oncology assets we have acquired from Novartis have great synergistic anti-cancer effects," said Dr. Chris Lu, founder and CEO of Laekna. "This synergy will allow us to apply various combinations to treat many cancer indications, including triple negative breast cancer and prostate cancer."

As part of this agreement, Novartis will receive an upfront payment, with additional payments at key development milestones as well as royalties on future sales.

On March 24, 2020 The National Comprehensive Cancer Network (NCCN) reported that it is now an alliance of 30 leading cancer centers, with the addition of two new Member Institutions: UCLA Jonsson Comprehensive Cancer Center and UT Southwestern Simmons Comprehensive Cancer Center (SCCC) (Press release, NCCN, MAR 24, 2020, View Source [SID1234555799]). These top-tier academic cancer centers are located in two of the most-populous cities in the United States, Los Angeles and Dallas, respectively, and serve large, diverse groups of patients. Both centers have a strong commitment for advancing innovative research that improves cancer care and reduces disparities. Experts from both centers will now be involved in the creation of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines)—the recognized standard for clinical direction in cancer care and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine.

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"We are very excited to incorporate the significant medical and scientific expertise from both UCLA Jonsson Comprehensive Cancer Center and UT Southwestern Simmons Comprehensive Cancer Center into our network of top academic cancer centers," said Robert W. Carlson, MD, Chief Executive Officer, NCCN. "Both have proven track records when it comes to improving outcomes and quality-of-life for people with cancer. Their facilities include top-notch programs throughout the spectrum of cancer management, including pediatric oncology, genetics, immunotherapy, telemedicine, and other increasingly-important areas of interest for NCCN and the greater cancer care community. They serve diverse, growing populations with strong immigrant representation at a time when the global need for NCCN Guidelines is higher than ever. The multi-disciplinary experts at UCLA and Simmons are among the best in the world, and both centers are ranked very highly by U.S. News & World Report. We are happy to have them work with us to improve and facilitate quality, effective, efficient, and accessible cancer care so patients can live better lives."

"We are honored and thrilled to become a member of the National Comprehensive Cancer Network," said Michael Teitell, MD, PhD, Director, UCLA Jonsson Comprehensive Cancer Center. "We look forward to joining our peer institutions and bringing our focus on cutting-edge research and top-quality cancer care to this association of the nation’s top cancer centers."

"We are excited to be able to join forces with the other leading cancer centers who are part of NCCN," said John Sweetenham, MD, Associate Director of Clinical Affairs, UT Southwestern Simmons Comprehensive Cancer Center. "Working with the other Member Institutions, we will ensure that the best possible evidence-based cancer care is available to patients throughout the nation and beyond. Our membership will bring the combined expertise of 30 elite cancer centers to the people of North Texas." Carlos L. Arteaga, MD, Director of the Simmons Cancer Center, echoed Dr. Sweetenham by adding "membership of the NCCN will greatly enhance our ability to apply the most recent cancer discoveries to our patient care mission."

In 2019 alone, more than 1,500 experts from NCCN Member Institutions contributed a combined 35,000+ hours to create and update NCCN Guidelines. Those guidelines provide the latest evidence- and expert consensus-based recommendations applying to 97 percent of cancers affecting patients in the United States, and also include prevention, screening, and supportive care topics. The development of the NCCN Guidelines is solely supported by membership dues from the NCCN Member Institutions.

The announcement of the addition of the UCLA Jonsson Comprehensive Cancer Center and UT Southwestern Simmons Comprehensive Cancer Center comes as NCCN celebrates its 25th anniversary year. The non-profit organization consisted of 13 centers when it was first founded in 1995.

In addition to joining the panels behind the NCCN Guidelines and their derivatives, experts from UCLA and SCCC will work with NCCN to provide continuing education; policy and advocacy outreach; best practices information; organization of clinical trials and research; global adaptations and translations; and up-to-date patient information. Visit NCCN.org to learn more about the various programs and their role in improving cancer care worldwide.

On March 24, 2020 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the fourth quarter and year ended December 31, 2019 and provided a business update (Press release, Gossamer Bio, MAR 24, 2020, View Source [SID1234555784]).

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"Our hearts are with the patients, families, caregivers and medical professionals suffering and sacrificing in the ongoing Covid-19 viral pandemic. We are monitoring the situation on a daily basis to understand the impact on Gossamer and our programs and are taking the necessary actions now to do what is best for our patients, employees and company," said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer Bio.

"2019 was a year of execution for Gossamer Bio, as we continued to advance all four of our clinical-stage product candidates in our target areas of immunology, inflammation and oncology. Notwithstanding the Covid-19 pandemic, we expect to continue our momentum in 2020, with data from all of our candidates expected this year. We are committed to advancing our product candidates and the field of medicine for the betterment of patients and their families, and we look forward to providing updates on these efforts throughout the year."

Clinical-Stage Product Candidate Updates

GB001: Oral DP2 Antagonist for Eosinophilic Asthma and Chronic Rhinosinusitis (CRS)

Gossamer has made available three poster presentations from its GB001 program for patients with asthma. All three posters, which Gossamer had planned to present at the now cancelled 2020 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, can be found in the Posters and Publications section of Gossamer’s website:

"Effect of the DP2 Antagonist GB001 on Asthma Worsening in Patients with Mild-Moderate Asthma" showed that GB001 treatment is associated with longer time to asthma worsening / exacerbation and observed treatment effects were greater in the populations with higher baseline FeNO and / or eosinophils.

"In Vitro and In Vivo Profile of GB001, a Potent and Selective DP2 Antagonist for the Treatment of Moderate-Severe Asthma" demonstrates that, in pre-clinical studies,

GB001 is an insurmountable antagonist and compares favorably to other DP2 antagonists in functional residence time and prolonged pharmacodynamic effects, while inhibiting immune cell infiltration and improving airway function.

"Corticosteroid Use Across Asthma Healthcare Providers: A Real-world Experience." The widespread use of OCS revealed by this claims analysis underscores the high level of unmet need for these patients and the need for new therapies.

Enrollment in the ongoing Phase 2b LEDA study in patients with moderate-to-severe eosinophilic asthma has been completed. We are on track to conduct an interim analysis in the second quarter of this year, following study completion by approximately two thirds of patients. Topline results are expected in the second half of this year.

Enrollment in the ongoing Phase 2 TITAN proof-of-concept study in chronic rhinosinusitis, both with and without nasal polyps has been completed. Topline data from the TITAN study are expected in the second half of this year.

We continue to evaluate the possibility of initiating a Phase 2 study in chronic spontaneous urticaria and expect to make this decision in the second half of the year following a review of available data and the competitive landscape.

GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial Hypertension (PAH)

Enrollment is underway in the Phase 1b study of GB002 in patients with PAH. Gossamer expects to report initial topline results from the study in the second quarter of this year.

Due to the ongoing Covid-19 viral pandemic, the Phase 2 study in patients with PAH will likely commence in the second half of this year. This trial will enroll functional class II and III PAH patients. Patients will remain on their background therapies throughout the study. The primary endpoint for this 24-week study will be change in PVR from baseline. A key secondary endpoint will be change from baseline in 6-minute walk distance at week 24.

GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease

Enrollment is complete in the Phase 1b study of GB004 in patients with active mild-to-moderate ulcerative colitis (UC). The primary goals of the study are to assess safety, tolerability, PK, PD and target engagement in patients with active disease. Gossamer expects to report topline results from this Phase 1b study in the second quarter of this year.

GB1275: Oral CD11b Modulator for Oncology Indications

Enrollment for the KEYNOTE-A36 Phase 1/2 study to evaluate GB1275 as a monotherapy and in combination with either KEYTRUDA (pembrolizumab) or chemotherapy in patients with selected advanced solid tumors is underway, and we expect to report initial Phase 1 data in the second half of this year.

Financial Results for Quarter and Full Year Ended December 31, 2019

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2019, were $401.8 million. In response to the ongoing Covid-19 viral pandemic and anticipated potential challenges to clinical trials globally, Gossamer has planned a series of cost-optimization initiatives. As a result, we currently expect cash, cash equivalents and marketable securities, and access to our debt facility will be sufficient to fund operating and capital expenditures to the middle of 2022.

Research and Development (R&D) Expenses: For the quarter ended December 31, 2019, R&D expenses were $42.6 million, compared to R&D expenses of $25.9 million for the same period in 2018. R&D expenses for the full year ended December 31, 2019, were $143.4 million compared to $55.3 million for the full year ended December 31, 2018. The increases were primarily due to an increase in expenses for GB001, GB002, GB004 and GB1275 and increased headcount.

In-Process Research and Development (IPR&D) Expenses: For the quarter ended December 31, 2019, IPR&D expenses were $1.6 million, compared to $0.0 million for the same period in 2018. IPR&D expenses for the full year ended December 31, 2019, were $3.6 million compared to $49.7 million for the full year ended December 31, 2018.

General and Administrative (G&A) Expenses: For the quarter ended December 31, 2019, G&A expenses were $11.6 million, compared to $13.9 million for the same period in 2018. G&A expenses for the full year ended December 31, 2019, were $39.1 million compared to $44.1 million for the full year ended December 31, 2018. The decreases were primarily attributable to a decrease in stock-based compensation costs, which was partially offset by increases in personnel-related costs, professional and legal fees, costs associated with insurance, and facility and office-related costs.

Net Loss: Net loss for the three months ended December 31, 2019, was $54.7 million, or $0.89 per share, compared to a net loss of $38.8 million, or $4.92 per share, for the same period in 2018. Net loss for the full year ended December 31, 2019, was $180.3 million, or $3.29 per share compared to a net loss of $147.0 million, or $22.59 per share, for the full year ended December 31, 2018.

On March 24, 2020 ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, reported financial and operating results for the year ended December 31, 2019 and provided a corporate strategic update (Press release, Thermogenesis, MAR 24, 2020, View Source [SID1234555800]).

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Key 2019 Achievements:

Net revenues for 2019 increased to $13.0 million, up 35% compared to 2018.
Gross profit for 2019 was $5.7 million, an increase of 156% compared to 2018.
Operating expenses were $10.4 million, a decrease of 77% as compared to 2018.
Completed the commercial launch of the AXP II System, an automated, fully closed cell separation system upgraded from the market-leading AXP System, for the advanced isolation, collection and storage of hematopoietic stem cell concentrates from cord blood and peripheral blood.
Announced that long-time customer, CBR, America’s largest cord blood bank, transitioned to the AXP II System.
Announced that Cordlife, a leading cord blood bank in Asia, signed a strategic agreement to start transitioning to the AXP II System
Received Health Canada approval of the Company’s PXP system for automated processing of bone marrow cells at the point-of-care. Entered into strategic supply agreement with Orthohealing Center Management to provide PXP System to Orthohealing Method’s network physician members.
Completed the commercial launch of the X-Series cell processing products and reagents, key components of the Company’s CAR-TXpress large scale cell manufacturing platform.
Completed the validations of system performance for the X-Series products from two prestigious academic medical centers at Duke University School of Medicine and University of North Carolina.
Entered an exclusive global supply agreement with Corning Incorporated under a five-year, renewable supply agreement for the X-Series product line and received $2 million upfront exclusivity fee.
Formed a new joint venture with HealthBanks Biotech (USA) named ImmuneCyte Life Sciences, Inc. ("ImmuneCyte"), to develop a proprietary immune cell banking service, leveraging ThermoGenesis’ CAR-TXpress cell processing platform. The joint venture, of which the Company owns 20% of the equity, received a $3 million equity investment.
Completed name change from Cesca Therapeutics Inc. to ThermoGenesis Holdings, Inc., reflecting the Company’s new strategic focus on being an automated cell processing tools and services provider in the cell and gene therapy field.
"Throughout 2019, not only did we achieve an increase in net revenues of 35% and an increase in gross profit of 156%, but we also took a number of strategic steps to position the Company to become a leading cell processing and manufacturing solution provider within the rapidly expanding cell and gene therapy field," said Chris Xu, PhD, Chief Executive Officer of ThermoGenesis. "The successful signing of the global supply agreement with Corning for our X-Series product line is expected to vastly increase visibility and awareness of our newly launched CAR-TXpress cell manufacturing platform going forward. The establishment of the ImmuneCyte joint venture, which will further leverage our CAR-TXpress platform to provide GMP quality immune cell banking services to healthy customers for future potential use in immunotherapies, is yet another step forward. Lastly, the divestiture of our clinical development assets, undertaken in conjunction with the formation of ImmuneCyte was a necessary step to allow us to stay focused solely on our scientific tools and services business in the cell and gene therapy field."

Jeff Cauble, Chief Financial Officer of ThermoGenesis, added, "The significant increase in sales of AXP and CAR-TXpress were important catalysts for our revenue growth. The AXP System provided an additional $3.1 million in revenue over 2018, while CAR-TXpress added $658,000. Gross profit improved, jumping to $5.7 million in 2019 compared to $2.2 million last year, a 156% improvement. Continued revenue growth and increased margins led to the Company having positive adjusted EBITDA for two quarters in 2019. Furthermore, Boyalife’s recent conversion of $3.0 million in principal and interest, as part of its Revolving Credit Agreement, not only illustrates their unwavering support of ThermoGenesis, but it will also reduce our interest obligation over the next year."

Recent Update on Coronavirus Pandemic

The current global pandemic of the coronavirus (COVID-19) has now affected more than 180 countries and regions, including over 40,000 cases in the United States alone. The disease has spread rapidly, leading to a tremendous impact on the U.S. healthcare system and causing societal disruption. The public health threat posed by COVID-19 is extremely high, both globally and in the U.S.

To effectively respond to the COVID-19 pandemic, ThermoGenesis and ImmuneCyte are working together mobilizing their expertise, global resources and relationships in the medical technology field to develop, register, import and seek U.S. Food and Drug Administration (FDA) approval for advanced point-of-care tests that will allow rapid diagnosis of the COVID-19 virus, including asymptomatic cases. The tests would be able to be done both at point-of-care settings, or potentially at home, without further burdening the already stressed healthcare system. A quick do-it-yourself (DIY) testing kit, as simple as a routine pregnancy test or diabetic glucose test, if approved, would allow millions of people currently quarantined at home to conduct a self-test.

Management noted that the first of such a rapid point-of-care test could be available as early as April through ThermoGenesis and ImmuneCyte. "We expect to file for an expedited review process with the FDA for the assay," noted Dr. Xu.

Financial Results for the Fiscal Year Ended December 31, 2019

Net revenues. Net revenues for the year ended December 31, 2019 was $13.0 million compared to $9.7 million for fiscal 2018, an increase of $3.3 million or 35%. The increase was driven by AXP revenues which increased by $3.1 million in 2019 with approximately 1,300 more cases sold in 2019 as compared to 2018. Additionally, AXP device sales increased by approximately $0.7 million in 2019, driven by customers upgrading to AXP II devices in the current year and CAR-TXpress sales increased by approximately $0.6 million. BioArchive and clinical development segment sales decreased slightly year over year.

Gross profit. Gross profit was $5.7 million or 44% of net revenues for the year ended December 31, 2019 compared to $2.2 million or 23% for the year ended December 31, 2018, an increase of $3.5 million or 156%. The increase was primarily due to AXP sales, generating approximately $2.2 million more in gross profit from disposables and devices. The remainder of the increase is due to increased gross profit from service revenue of approximately $0.2 million and additional sales of CAR-TXpress which resulted in approximately $0.3 million more gross profit.

Sales and marketing expenses. Sales and marketing expenses were $1.7 million for the year ended December 31, 2019, as compared to $1.4 million for the year ended December 31, 2018, an increase of $0.3 million or 22%. The increase was driven by stock compensation expense and increased salaries and benefits.

Research and development expenses. Research and development (R&D) expenses were $2.4 million for the year ended December 31, 2019, compared to $3.0 million for the year ended December 31, 2018, a decrease of $0.6 million or 20%. The decrease is primarily due to a decline in personnel costs related to corporate reorganization in June 2018.

General and administrative expenses. General and administrative expenses for the year ended December 31, 2019 were $6.4 million, compared to $8.3 million for the year ended December 31, 2018, a decrease of $1.9 million or 23%. The decrease was driven by a decline in personnel costs of approximately $1.2 million and a loss on the disposal of fixed assets of approximately $1.3 million incurred in 2018. India general and administrative expenses were also approximately $0.3 million less in 2019. These decreases were offset by a $1.4 million expense as the result of the verdict against the Company in the Mavericks lawsuit.

Impairment Charges: The Company incurred no impairment charges during the year ended December 31, 2019 as compared to impairment charges of $33.1 million during the year ended December 31, 2018. In 2018, the Company recorded impairment charges of $13.2 million to goodwill and $19.9 million to the Company’s intangible assets in the Clinical Development Segment.

Interest Expense. Interest expense increased to $4.5 million for the year ended December 31, 2019 as compared to $2.7 million for the year ended December 31, 2018, a difference of $1.8 million. The increase is driven by interest recorded and the amortization of the debt discount, interest expense and the loss on the extinguishment of debt related convertible notes issued by the Company during 2019. Additionally, 2019 had more in interest and amortization of the debt discount on the beneficial conversion feature related to the Revolving Credit Agreement with Boyalife.

Loss on Extinguishment of Debt: The Company recorded a loss of extinguishment of debt of $0.8 million for the year ended December 31, 2019 as compared to $0 for the year ended December 31, 2018. The increase is due to the loss on the extinguishment of the convertible note issued in January 2019, which was deemed to be extinguished as a result of its amendment in July 2019.

Benefit for Income Taxes: For the year ended December 31, 2019, the Company has no income tax benefit compared to $4.7 million for the year ended December 31, 2018. The benefit for income tax in 2018 was due to the impairment of the indefinite lived intangible assets for the clinical protocols and goodwill.

Net loss. For the year ended December 31, 2019, the Company reported a comprehensive loss attributable to common stockholders of $9.5 million, or ($3.36) per share, based on approximately 2.8 million weighted average basic and diluted common shares outstanding. This compares to a comprehensive net loss of $39.7 million, or ($21.57) per share, based on approximately 1.8 million weighted average basic and diluted common shares outstanding for the year ended December 31, 2018.

Adjusted EBITDA. In addition to the results reported under US GAAP, the Company also uses a non-GAAP measure to evaluate operating performance and to facilitate the comparison of our historical results and trends. The Company uses the metric to determine operational cash flow. Adjusted EBITDA loss for the year ended December 31, 2019 was $3.3 million, as compared to a loss of $9.1 million for the year ended December 31, 2018, an increase of $5.8 million or 64%. The increase was due to $3.4 million in additional gross profit as the result of higher sales, decreased overhead expenses and lower costs. Additionally, the Company decreased personnel costs by approximately $1.5 million in 2019 as compared to 2018. These decreases were offset by a $1.4 million expense related to the Mavericks lawsuit. A reconciliation of adjusted EBITDA loss to net loss is set forth below.

At December 31, 2019, the Company had cash and cash equivalents totaling $3.2 million, compared with $2.4 million at December 31, 2018. Working capital improved to $3.2 million at December 31, 2019 as compared to $2.3 million at December 31, 2018.

Conference Call and Webcast Information

ThermoGenesis will host a conference call today at 1:30 p.m. PDT/4:30 p.m. EDT. To participate in the conference call, please dial 1-844-889-4331 (domestic), 1-412-380-7406 (international) or 1-866-605-3852 (Canada). To access a live webcast of the call, please visit: View Source

A replay of the call can be accessed by dialing 1-877-344-7529 (domestic), 1-412-317-0088 (international) or 855-669-9658 (Canada), and referencing access code 10139041. The replay will be available until April 9, 2020.

On March 24, 2020, Kura Oncology, Inc. (the "Company") entered into an Office Lease (the "Lease") with East Office Operating Limited Partnership ("Landlord") for the lease of approximately 16,541 square feet of rentable area of the building located at Two Sea Port Lane, Boston, Massachusetts (the "Premises"). The commencement date of the Lease is April 1, 2020. The Company expects to use the Premises for general office use. The initial term of the Lease (the "Initial Term") is four years and three months and the Company has one option to extend the Lease for a period of five additional years. The minimum rent payable by the Company under the Lease will be approximately $105,500 per month for the first year of the Lease, which amount will increase by 2.0% per year over the Initial Term. The Company will also be responsible for the payment of additional rent to cover the Company’s share of the annual operating expenses of the building, the annual tax expenses of the building, the annual utilities costs for the building and parking. In the event of a default of certain of the Company’s obligations under the Lease, Landlord would have the right to terminate the Lease and recover certain unpaid rent and expenses.

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The foregoing description of the Lease does not purport to be complete and is subject to, and qualified in its entirety by reference to, the full text of the Lease. The Company intends to file a copy of the Lease with the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020.