On March 10, 2019 XOMA Corporation (Nasdaq: XOMA) reported its fourth quarter and full-year 2019 financial results and business highlights (Press release, Xoma, MAR 10, 2020, View Source [SID1234555373]).

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!

"2019 was a tremendous year for XOMA. We added 20 new assets to our royalty license portfolio, eleven of which are clinical-stage candidates. One of our licensees, Janssen Biotech, conducted a portfolio review and identified multiple compounds that were born from an agreement between our companies. As we are constructing XOMA’s portfolio to generate royalty candidates over an extended time horizon, we acquired interests in two exciting platform technologies that we believe will produce multiple clinical candidates to further increase our royalty license portfolio. We entered 2020 with a royalty-potential portfolio of more than 65 partner-funded assets," stated Jim Neal, Chief Executive Officer at XOMA. "Our business model has the potential to generate significant revenue from milestone payments and royalties. In 2019, we received $15.8 million from our partners. Given our royalty acquisition achievements over the last three years and the opportunities before us, we raised an additional $22 million in a rights offering at the end of the year. We anticipate we will deploy this capital to continue building XOMA’s royalty-interest and milestone-bearing portfolio."

Business Highlights
XOMA completed four milestone and royalty acquisition transactions in 2019 that added eleven new potential royalty-bearing assets and interests in two platform technologies to the Company’s portfolio.

Acquired a milestone and royalty interest in two Bayer assets, one Bayer option, and two unpartnered candidates from Aronora.
Acquired a royalty interest in one Novartis asset and five clinical-stage assets from Palobiofarma.
Acquired royalty interest in platform technologies being developed at Bioasis Technologies and Sonnet BioTherapeutics.
Added nine Janssen Biotech assets to XOMA’s royalty portfolio.
Received $15.8 million from partners during 2019.
Completed a $22 million rights offering with XOMA stockholders including BVF Partners, LP.
2019 Updates About Partnered Assets in Development
"Last year two of our partners, Novartis and Sesen Bio, announced significant clinical developments that have the potential to offer patients with few treatment options the opportunity to access new therapies that have clinically meaningful benefits," Mr. Neal continued.

Novartis-licensed assets:

Novartis presented first-of-its-kind histology data with iscalimab (CFZ533)1 at the American Transplant Congress. The data showed 60 percent of iscalimab-treated transplant patients have normal kidney histology at least one year after transplant, compared with 0 percent with tacrolimus (current standard of care)2. The company highlighted iscalimab and its development plans at the Novartis R&D Day on December 5, 2019. Novartis now has seven clinical studies with iscalimab underway.
Novartis launched its clinical program for gevokizumab (VPM087) (anti-IL1β allosteric modulator monoclonal antibody) 3 with a clinical study in patients with metastatic colorectal cancer, gastroesophageal cancer, and renal cell carcinoma.
Sesen Bio reported positive top-line Phase 3 data and subsequently initiated its rolling Biologics License Application (BLA) filing for Vicinium for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)4. The company has stated it anticipates completing its filing in the second half of 2020.

Takeda-licensed assets:

Takeda expanded the TAK-0794 clinical program and now has four studies ongoing.
Takeda and Molecular Templates began enrolling patients in their first TAK-1694 clinical program.
Aronora initiated a Phase 2 study with AB002 (E-WE thrombin)4 in patients with end-stage renal disease on chronic hemodialysis.

AVEO Oncology expanded the clinical program testing ficlatuzumab (AV-299)4 and now is studying the compound’s potential efficacy in a wide variety of oncology indications.

Mr. Neal concluded, "The clinical advancements continued into 2020. In February, Rezolute, Inc., announced the launch of its Phase 2b clinical trial for RZ358 (formerly XOMA 358) in patients with congenital hyperinsulinism (CHI). Given the insight we gained into this terrible condition during our early development of this compound and the extraordinary families we met, we are truly hopeful Rezolute succeeds in its development efforts for RZ358."

Financial Results
XOMA recorded total revenues of $0.4 million for the fourth quarter of 2019, compared to $1.7 million for the fourth quarter of 2018. For the full year of 2019, XOMA recorded revenues of $18.4 million, compared to $5.3 million for the full year of 2018. Revenues for the full year of 2019 reflect $14.0 million recognized under the Company’s license agreement and common stock purchase agreement with Rezolute and $2.5 million in revenue earned from a one-time payment under XOMA’s license agreement with Janssen. Revenues for the full year of 2018 include $1.8 million recognized under the license agreement and common stock purchase agreement with Rezolute, $1.4 million in milestone revenue earned under XOMA’s license agreement with Janssen, and $0.8 million in milestone revenue earned under XOMA’s license agreement with Compugen.

Research and development (R&D) expenses were $0.1 million for the fourth quarter of 2019, compared to $0.2 million for the fourth quarter of 2018. Research & development expenses for the full year of 2019 were $1.3 million, compared to $1.7 million for the same period in 2018. The decrease of $0.4 million in 2019, as compared with 2018, was primarily due to a reduction in headcount of R&D employees.

General and administrative expenses were $4.3 million for the fourth quarter of 2019, compared to $4.3 million for the fourth quarter of 2018. General & administrative expenses were $21.0 million for the full year of 2019, compared to $18.6 million for the full year of 2018. The increase of $2.4 million in 2019 as compared with 2018 was primarily due to a $0.9 million increase for expenses incurred in connection with a separation agreement with our Chief Business Officer, which included $0.5 million in stock-based compensation expense for modifications to vested stock options and $0.4 million in separation benefits, an increase of $0.7 million in stock-based compensation excluding the option modifications, a $0.6 million increase in common area maintenance charges related to our legacy leases, and a $0.4 million increase in expenses related to investor communications.

Interest expense for the fourth quarter of 2019 was $0.6 million, as compared to $0.4 million for the fourth quarter of 2018. For the full year of 2019, interest expense was $1.9 million, compared with $0.9 million reported in the full year of 2018. The increase in 2019 is primarily due to the increase in the outstanding loan balance with Silicon Valley Bank due to the Company’s borrowing activities related to the royalty purchase agreements with Aronora and Palobiofarma.

Other income, net was $0.3 million for the fourth quarter of 2019, compared to $0.7 million for the corresponding quarter of 2018. Total other income, net was $3.8 million for the full year of 2019, compared to $4.3 million for the corresponding period of 2018. The decrease in the full year of 2019 when compared to the full year of 2018 primarily reflects the discontinuation of income under the Ology Bioservices agreement of $2.5 million and a loss of $0.4 million recognized due to the early termination of our legacy building leases, partially offset by the increase in sublease income of $1.2 million and the change in fair value adjustment of Rezolute common stock of $0.9 million.

Net loss for the fourth quarter of 2019 was $4.3 million, compared to net loss of $3.0 million for the fourth quarter of 2018. Net loss for the full year of 2019 was $2.0 million, compared to net loss of $13.3 million for the full year of 2018.

On December 31, 2019, XOMA had cash of $56.7 million compared with $45.8 million on December 31, 2018. The Company’s current cash position is expected to be sufficient to fund its operations for multiple years.

On March 10, 2020 Medivir AB (Nasdaq Stockholm: MVIR) reported that the first patient with advanced liver cancer has been dosed in the phase Ib study of MIV-818 (Press release, Medivir, MAR 10, 2020, View Source [SID1234555389]). The MIV-818 phase I study (NCT03781934) consists of two parts: (i) the already completed phase Ia, which was a within-patient dose-escalation study, and (ii) the phase Ib between-patient dose-escalation study, a classic 3+3 dose-escalation multi-center study in patients with advanced liver cancer.

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!

The phase Ia study demonstrated a liver-cancer directed effect of MIV-818 and five out of nine patients were considered to have stable liver disease after MIV-818 treatment.

The primary objective of the phase Ib study is to establish the safety and tolerability profile of MIV-818. A secondary objective is to further explore the efficacy of MIV-818.

"Patients with advanced liver cancer have limited treatment options and the unmet medical need is large" said Dr Uli Hacksell, CEO of Medivir. "Having obtained an encouraging proof-of-concept for the liver-cancer directed effect of MIV-818 in phase Ia, we hope to get additional supportive data from the phase Ib study. We believe that MIV-818 has the potential to provide liver cancer patients with major therapeutic benefits."

For further information, please contact:
Dr Uli Hacksell
CEO
Medivir AB
phone: +46(0)8-5468-3100.

Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.55 CET on 10 March, 2020.

About liver cancer

Liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC are capable of extending the lives of patients, treatment benefits are low while death rates remain high. HCC is a very diverse disease with multiple cancer cell types and without the tumor-specific mutations seen in other tumor types. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

About MIV-818

MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted, orally administered drug to benefit patients with HCC and other forms of liver cancer.

On March 10, 2020 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported financial results for the third quarter and first nine months of fiscal 2020 ended January 31, 2020 (Press release, Avid Bioservices, MAR 10, 2020, View Source [SID1234555358]).

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!

Highlights Since October 31, 2019

"During the third quarter of 2020, Avid strengthened both its project pipeline and backlog, and the fundamentals of the business remained strong," said Rick Hancock, interim president and chief executive officer of Avid. "However, the company faced production challenges during the period related to a problem with a specific piece of equipment which resulted in the termination of in-process manufacturing runs, and the postponement of several other manufacturing runs scheduled to commence during the third quarter. Though we are now implementing the necessary corrections, the temporary production interruption resulted in lower revenue and profits for the third quarter, and we expect it to also impact revenues and profits for the fourth quarter of fiscal 2020. For this reason, we are adjusting our revenue guidance for fiscal 2020 to $55 – $59 million versus our prior guidance of $64 – $67 million. It is our expectation that this problem will be behind us soon, and as such, we anticipate that the impact will be contained to fiscal 2020.

"While we are disappointed that this temporary operational setback will negatively impact our fiscal 2020 results, we anticipate that we will be able to recover those revenues in fiscal 2021. We remain optimistic about Avid’s growth potential.

"Critical to achieving this growth is the continued expansion of Avid’s customer and project base. To lead this effort, we recently welcomed Timothy Compton to the Avid team as our chief commercial officer. During the third quarter, Tim launched the first phase of an aggressive business development campaign. As a result, we signed agreements to add one new customer and multiple additional manufacturing campaigns with existing customers during the period.

"With respect to operations, we continue to make progress on projects to optimize our existing Myford facility while finalizing plans for its future expansion. We will continue to update you moving forward as these plans progress."

Financial Highlights and Guidance

The company is adjusting revenue guidance for the full fiscal year 2020 to $55 million to $59 million from prior full fiscal year 2020 guidance of $64 million to $67 million.

Revenue was $13.6 million for the third quarter of fiscal 2020, consistent with $13.8 million for the third quarter of last fiscal year. For the nine months ended January 31, 2020, revenues were $47.2 million, a 29% increase as compared to revenues of $36.5 million during the same prior year period. The slight decrease during the third quarter of fiscal 2020 can primarily be attributed to a decrease in process development revenue, combined with the impact of the production interruption described above, which were largely offset by an increase in the number of in-process and completed manufacturing runs conducted during the quarter compared to the same prior year quarter. Likewise, the increase during the first nine months of fiscal 2020 was primarily due to an increase in the number of in-process and completed manufacturing runs, a result of growing demand from a more diverse client base, partially offset by a decrease in process development revenue and the third quarter production interruption.

As of January 31, 2020, revenue backlog was approximately $58 million, an increase of 12% compared to the second quarter of fiscal 2020. The company expects to recognize the majority of this backlog within the next 12 months.

Gross margin for the third quarter of fiscal 2020 was 6%, a decrease compared to the 15% gross margin for the third quarter of fiscal 2019. The decrease in gross margin for the quarter was primarily attributed to the costs associated with the aforementioned production interruption, an increase in depreciation expense from the acquisition of new equipment, and a net decrease in revenues. Gross margin for the nine months ended January 31, 2020 was 11%, up slightly compared to 10% in the prior year period. This increase was primarily due to an increase in manufacturing runs, partially offset by costs associated with payroll and related costs, higher facility and equipment related costs primarily associated with the production interruption described above, increased depreciation expense from the acquisition of new equipment, and general equipment repairs and maintenance costs.

Selling, general and administrative expenses ("SG&A") for the third quarter of fiscal 2020 were $3.0 million, a decrease of 8% compared to $3.2 million for the third quarter of fiscal 2019. This decrease was primarily due to a decrease in accrued bonuses for fiscal 2020, partially offset by an increase in employee separation costs. For the first nine months of fiscal 2020, SG&A expenses were $11.0 million, an 19% increase compared to $9.3 million for the first nine months of fiscal 2019. The increase in SG&A was primarily attributed to employee separation-related expenses and increased stock-based compensation. When excluding the separation-related expenses, SG&A increased by 10% during the first nine months of fiscal 2020 as compared to the prior year.

For the third quarter of fiscal 2020, the company recorded a consolidated net loss attributable to common stockholders of $3.5 million or $0.06 per share, compared to a consolidated net loss attributable to common stockholders of $2.6 million or $0.05 per share, for the third quarter of fiscal 2019. For the first nine months of fiscal 2020, the company recorded a consolidated net loss attributable to common stockholders of $9.3 million or $0.17 per share, compared to a consolidated net loss attributable to common stockholders of $8.2 million or $0.15 per share, for the first nine months of fiscal 2019.

Avid reported $30.7 million in cash and cash equivalents as of January 31, 2020, compared to $32.4 million on April 30, 2019.
More detailed financial information and analysis may be found in Avid Bioservices’ Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Recent Corporate Developments

Appointed Timothy (Tim) Compton as chief commercial officer. Mr. Compton has extensive experience in commercial operations, including sales team management, business development, marketing and corporate development. In his new role, he will be responsible for driving the continued growth of Avid’s CDMO business, including the ongoing expansion of the company’s commercial and clinical client base.

Expanded our customer base with the addition of one new customer and executed multiple project expansion orders with existing customers representing additional revenue backlog of $20 million during the third quarter.

Advanced planning and design to both enhance our Myford facility, and support its future expansion. These near-term improvements include installing a pharmaceutical grade water system, and upgrading key IT systems and general infrastructure. We expect the installation and validation of the water system to take place in late calendar year 2020 and the IT system enhancements and general infrastructure upgrades to be complete by the end of fiscal 2021.
Conference Call

Avid will host a conference call and webcast this afternoon, March 10, 2020, at 4:30 PM EDT (1:30 PM PDT).

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source

On March 10, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that Clay Siegall, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the Barclays Global Healthcare Conference on Wednesday, March 11, 2020 at 4:20 p.m. Eastern Time (Press release, Seattle Genetics, MAR 10, 2020, View Source [SID1234555374]). The conference will be held in a virtual meeting format. The presentation will be webcast live and available for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section.

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!

On March 10, 2020 Kuur Therapeutics reported the launch of its new business in partnership with Baylor College of Medicine and Baylor’s Center for Cell and Gene Therapy (Press release, Kuur Therapeutics, MAR 10, 2020, View Source [SID1234555391]). Houston-based Kuur Therapeutics will advance the work of its predecessor, Cell Medica, to develop anti-cancer therapies using its innovative chimeric antigen receptor natural killer T cell (CAR-NKT) therapy platform.

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!

IP Group, Baylor College of Medicine and Schroeder Adveq are investing to support two phase 1 studies: GINAKIT 2 (autologous CAR-NKT cells in neuroblastoma) and ANCHOR (allogeneic CAR-NKT cells in CD19 malignancy). The ongoing GINAKIT2 study is now enrolling patients at the third dose level and the ANCHOR study IND has recently been approved by the FDA, with first patient treatment expected in 1H 2020. The funding will also support the preclinical development of an allogeneic CAR-NKT product for treatment of hepatocellular carcinoma, ahead of an IND submission anticipated in 1H 2021.

In conjunction with the new investment, Kevin S Boyle, Sr, was named CEO of Kuur, succeeding Chris Nowers. Mr Boyle joined Cell Medica as CFO in February 2018. Kevin previously held senior finance roles at both NASDAQ-listed and private equity backed companies. He is an accomplished capital markets professional, having raised over $2.0 billion in equity and debt capital.

Kuur’s novel CAR-NKT platform is a next-generation technology of engineered immune cells with enhanced functions for the treatment of hematological and solid tumors. It utilizes the unique properties of NKT cells, a specialized type of innate lymphocyte, which shares properties with both T and NK cells. This platform, developed in the laboratory of Baylor Principal Investigator Leonid Metelitsa, is exclusively licensed to Kuur by its partner and collaborator, Baylor College of Medicine.

Annalisa Jenkins, Chair of Kuur’s Board, said: "We are fortunate to have Kevin step up to the role of CEO. He will act as a change agent, leading the company during a crucial period for our clinical trials and working to secure the additional capital required to progress our two lead CAR-NKT products through the clinic.

"The Board would also like to thank Chris for his exceptional leadership during a transition period that has resulted in a company on the right path forward for its investors, with a focus on its important collaborations."

Kevin S Boyle, Sr, Kuur’s CEO, said: "I am excited to lead Kuur Therapeutics at such a pivotal moment. We are making final preparations to take our off-the-shelf program into the clinic and believe the allogeneic approach holds huge promise for unlocking the potential of CAR therapies for large patient populations. Compared with patient-specific autologous CAR products, it is immediately available for treatment and less expensive to manufacture."

Leonid S. Metelitsa, BCM Principal Investigator, said: "My goal is to make a difference in the lives of cancer patients, especially children, and I’m excited to be working with the Kuur team to make this goal a reality. I believe that the NKT-cell platform technology, developed in my laboratory and progressed to first-in-human clinical testing in close collaboration with colleagues at BCM and Texas Children’s Hospital, offers a unique route to next-generation off-the-shelf CAR therapies for a broad range of malignancies."