On January 9, 2020 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) ("Infinity") reported a $20 million non-dilutive asset-backed financing with BVF Partners L.P. ("BVF"), Infinity’s largest shareholder (Press release, Infinity Pharmaceuticals, JAN 9, 2020, View Source [SID1234552924]). This investment by BVF entails no equity to be issued by Infinity and has its sole recourse in potential royalty payments due on future sales of patidegib, a hedgehog pathway inhibitor discovered by Infinity and licensed to PellePharm in 2013. Infinity has the right to repay the $20 million plus interest to repurchase the right to future patidegib royalties during the next three years under certain conditions.

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"This non-dilutive financing is representative of our very collaborative relationship with BVF and their tremendous support as a value-added investor. Leveraging our financial interest in patidegib royalties enables us to preserve significant upside for all of Infinity’s shareholders," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "Importantly, with this financing, we now have over $60 million cash on hand to fund all of our current IPI-549 trials to key data readouts throughout 2020 and into 2H 2021. These data readouts include studies of IPI-549 in a randomized, controlled Phase 2 study in bladder cancer and in front line settings with novel triple therapy combinations, including in indications for which we have seen clinical activity, as part of a thoughtful clinical development strategy designed to reveal the potentially transformative impact of reprogramming macrophages with IPI-549."

Mark Lampert, President of BVF, Inc., commented, "In light of our longstanding association with Infinity, the enormous potential of IPI-549 to help cancer patients, which is not currently reflected in the company’s stock price, and our admiration for management’s dilution sensitivity in advance of data, we wanted to help Infinity raise capital without equity dilution. BVF’s large existing ownership stake in the company was fundamental in aligning our interests with the company to preserve IPI-549 upside for all shareholders, and we believe this innovative financing structure accomplishes the objective in a win-win manner."

Within this extended cash runway into 2H 2021, Infinity expects to generate data on approximately 525 patients from the following trials:

MARIO-275, our global randomized Phase 2 study in collaboration with Bristol-Myers Squibb (BMS), evaluating IPI-549 in combination with Opdivo in patients with advanced urothelial cancer.
MARIO-3, our Phase 2 study in collaboration with Roche/Genentech evaluating IPI-549 in combination with Tecentriq and Abraxane as a front-line treatment in patients with triple negative breast cancer (TNBC) and in combination with Tecentriq and Avastin as a front-line treatment for patients with renal cell cancer (RCC).
MARIO-1, our Phase 1/1b study in collaboration with BMS evaluating IPI-549 in combination with Opdivo in patients with advanced solid tumors.
Arcus Biosciences’ Phase 1 collaboration study evaluating IPI-549 in a novel, checkpoint inhibitor free regimen that includes their dual adenosine receptor inhibitor, AB928, and Doxil in patients with relapsed/refractory TNBC.
In addition to the initial $20 million payment, Infinity is eligible to receive from BVF an additional $5 million payment upon positive data from PellePharm’s Phase 3 trial in patients with Gorlin Syndrome. PellePharm announced the completion of enrollment in a Phase 3 trial of a topical formulation of patidegib in patients with Gorlin Syndrome in December 2019. FDA granted Breakthrough Therapy Designation and Orphan Drug Designation to PellePharm for a topical formulation of patidegib in patients with Gorlin Syndrome in November 2017. Infinity retains rights to all patidegib milestone payments from PellePharm of up to $9 million in regulatory and first commercial sale milestones and $37.5 million in sales threshold milestones.

Infinity has the option to repurchase the rights to future patidegib royalties by paying BVF an amount equal to the principal amount received by Infinity plus interest at any time when the 20-day volume weighted average price per share of Infinity’s common stock exceeds $5.00 during the next three years.

Furthermore, Infinity retains its approximately 1% equity interest in PellePharm. PellePharm has previously announced that LEO Pharmaceuticals has the right to acquire PellePharm following Phase 3 data for total potential consideration of $690 million.

If, during the period ending three years from the date of the agreement or earlier in the event Infinity has exercised its repurchase option for future patidegib royalties from BVF, Infinity completes future equity financings above a specified share quantity threshold and below a specified price threshold, then Infinity has agreed to provide BVF with 50% warrant coverage at a 50% premium to the price at which such shares in excess of the share quantity threshold were sold.

The terms and conditions of the transaction are described in more detail in a Form 8-K filed by Infinity with the Securities and Exchange Commission on January 9, 2020.

On January 9, 2020 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals, will provide a corporate overview at the 38th Annual J.P. Morgan Global Healthcare Conference on Thursday, January 16, 2020 at 9:00 am Pacific Time at the Westin St. Francis Hotel in San Francisco, California (Press release, Infinity Pharmaceuticals, JAN 9, 2020, http://investors.infi.com/news-releases/news-release-details/infinity-pharmaceuticals-present-corporate-overview-38th-annual [SID1234552923]).

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A live webcast of the presentation will be available on the Investors/Media section of Infinity’s website at www.infi.com, and will be available for 30 days following the event.

About Infinity and IPI-549

Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is advancing IPI-549, a first-in-class, oral immuno-oncology development candidate that selectively inhibits PI3K-gamma, in multiple clinical studies. MARIO-1 is an ongoing Phase 1/1b study evaluating IPI-549 as a monotherapy and in combination with Opdivo (nivolumab) in approximately 225 patients with advanced solid tumors including patients refractory to anti-PD-1 therapy. MARIO-275 and MARIO-3 have recently initiated. MARIO-275 is a global, randomized, combination study of IPI-549 combined with Opdivo in I/O naïve urothelial cancer patients. MARIO-3 is the first IPI-549 combination study in front-line advanced cancer patients and is evaluating IPI-549 in combination with Tecentriq and Abraxane in front-line TNBC and in combination with Tecentriq and Avastin in front-line RCC. With the MARIO-275, MARIO-3 and the MARIO-1 studies, Infinity is evaluating IPI-549 in the anti-PD-1 refractory, I/O-naïve and front-line settings. For more information on Infinity, please refer to Infinity’s website at www.infi.com.

On January 9, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTC QB: IPATF) a provider of best-in-class therapeutic antibody discovery capabilities for the global industry, reported that its wholly owned subsidiary U-Protein Express BV signed a long-term lease contract for the new multi-tenant building for life sciences "Accelerator" at the Utrecht Science Park (Utrecht, The Netherlands) (Press release, ImmunoPrecise Antibodies, JAN 9, 2020, https://www.immunoprecise.com/immunoprecise-subsidiary-joins-genmab-and-merus-in-expansion-to-new-biotech-accelerator-at-the-center-of-europes-most-competitive-science-region/ [SID1234552922]). In addition to accommodating large biotechnology companies, the new building will offer space to companies that want to accelerate their development. The design is based on the vision of listed biotechnology companies Genmab (NASDAQ:GMAB) and Merus (NASDAQ:MRUS): Improving lives of patients by developing innovative therapies for cancer treatment, partly by entering into valuable collaborations. Accelerator endorses this ambition by creating a unique hub within the innovation ecosystem.

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Accelerator offers Utrecht Science Park a welcome addition to accommodate more innovative companies in the Life Sciences sector. The building will be developed aiming for high sustainability requirements (BREEAM Excellent) and will have a prominent place at the entrance of Utrecht Science Park.
"We are happy to welcome U-Protein Express to Accelerator. Accelerator is designed to facilitate and connect Life Sciences companies, creating a tight international community within Utrecht Science Park. U-Protein Express is a great addition to the ecosystem and Accelerator will stimulate their growth ambitions," said Chiel van Dijen, Commercial Director of Kadans Science Partner.

Dr. Martin Hessing, General Manager of U-Protein Express, stated: "We are delighted to move our continuously expanding service activities towards the new building alongside important stakeholders such as Genmab and Merus. This will enable us to keep in pace with our growing contract research business as Accelerator will give us over 3-4 times current capacity".

"The investments we are making in our European operations are a strong reflection of ImunoPrecise’s position in the marketplace and positive outlook for the future," said Dr. Jennifer Bath, President and CEO. "The Accelerator provides state-of-the-art facilities that enable our talented team to respond to the increasing demand for our services and innovative technologies."

On January 9, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that it will host a Clinical Data Call on Wednesday, February 19, 2020 at 10:30 am Eastern Time (Press release, Cellectar Biosciences, JAN 9, 2020, View Source [SID1234552921]).

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Members of Cellectar’s senior management team and Dr. Sikander Ailawadhi, M.D., the lead investigator for the company’s Phase 2 study, will provide additional clinical data, as well as an update and analysis of the CLR 131 Phase 1 and Phase 2 hematology focused trials. The team will also provide a summary of the data for patients with relapsed/refractory B-cell malignancies, including patients with multiple myeloma and select non-Hodgkins lymphoma. Additionally, the team will review the current treatment landscape and unmet medical need for treating patients with these cancers, and provide an overview of the market opportunity and its clinical development plan for CLR 131.

Sikander Ailawadhi, M.D., is an Associate Professor, Division of Hematology/Oncology at Mayo Clinic Florida and is the lead investigator for the company’s Phase 2 CLOVER-1 trial of CLR 131 in patients with relapsed/refractory B-cell hematologic cancers. Dr. Ailawadhi was awarded the 2013 NCI CCITLA as an Assistant Professor of Medicine at the Norris Cancer Center, University of Southern California (USC), Los Angeles CA. Subsequently, he joined the Division of Hematology and Oncology at Mayo Clinic in Florida as a Senior Associate Consultant in order to pursue his career goal of clinical, translational and outcomes-based research in B-cell malignancies, especially plasma cell disorders.

Dial-In & Webcast Information

Domestic: 877-705-6003

International: 201-493-6725

Conference ID: 13697717

Webcast: View Source

A replay of the call will be available on the Events section on the Investor Relations page of company’s website following the live event.

About the Phase 2 CLOVER-1 Trial

CLOVER-1 is a Phase 2 study of CLR 131 being conducted in approximately 10 leading cancer centers in the United States in patients with relapsed/refractory B-cell hematologic cancers. The hematologic cancers being studied in the trial include multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL).

The study will enroll up to 80 patients. Its primary endpoint is clinical benefit response (CBR), with additional endpoints of overall response rate (ORR), progression free survival (PFS), median overall survival (OS) and other markers of efficacy following a fractionated dose of 37.5mCi/m2 of CLR 131 administered in two 30-minute infusions of 18.75mCi/m2 of CLR 131 administered on day 1 and day 7 (± 1), with the option for a second dose cycle approximately 75-180 days later.

Cellectar was awarded approximately $2 million in non-dilutive grant funding from the National Cancer Institute to help fund the trial. More information about the trial, including eligibility requirements, can be found at www.clinicaltrials.gov, reference NCT02952508.

About the Phase 1 R/R MM Trial

The Phase 1 multicenter, open-label, dose-escalation study is designed to evaluate the safety and tolerability of CLR 131 administered as a 30-minute IV infusion, either as a single bolus dose or as two fractionated doses, in patients with relapsed/refractory multiple myeloma. All doses to date have been deemed safe and well tolerated by an independent Data Monitoring Committee (DMC). Based on the data and the recommendation of the DMC, the company is enrolling a Cohort 7 where patients will receive 40mCi/m2 fractionated dose of CLR 131.

About CLR 131

CLR 131 is a small-molecule, targeted Phospholipid Drug Conjugate (PDC) designed to deliver cytotoxic radiation directly to cancer cells, while limiting exposure to healthy cells. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and two Phase 1 dose-escalating clinical studies, one in multiple myeloma and one in pediatric solid tumors and lymphoma. CLR 131 was granted Orphan Drug designation for the treatment of multiple myeloma by both the U.S. and the European Commission, and was granted U.S. Orphan Drug designation for the treatment of lymphoplasmacytic lymphoma and was granted U.S. Orphan Drug and Rare Pediatric Disease designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma.

On January 9, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported certain unaudited preliminary performance results for the fourth quarter and full-year 2019 (Press release, Castle Biosciences, JAN 9, 2020, View Source [SID1234552920]). The Company will report its full financial results and other metrics during its fourth quarter and year-end 2019 conference call, which is expected to be held in March 2020. Additionally, the Company expects to provide certain preliminary guidance for 2020 when it reports its final results for the fourth quarter and year-end 2019.

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"We are pleased with our solid execution in 2019, particularly the acceleration in DecisionDx-Melanoma volume seen since our first quarter 2019 commercial expansion," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We attribute this growth to a combination of ongoing evidence development, which included eight peer-reviewed publications, as well as the early 2019 commercial expansion. As a result of this growth, we executed a second commercial expansion on December 1, 2019. And as of December 31, 2019, we have more than doubled our commercial personnel compared to December 31, 2018. Evidence development continued in 2019, including prospective studies that further support the two intended uses of our DecisionDx-Melanoma test, which we believe contributed to the posting of a draft Medicare Local Coverage Determination (LCD) expansion, as well as the acceptance of our application for a Category I MAAA Current Procedural Terminology (CPT) code by the American Medical Association’s CPT Editorial Panel.

"We believe the substantial volume growth in our lead product, DecisionDx-Melanoma, is providing more patients diagnosed with early stage cutaneous melanoma the opportunity to have informed discussions with their doctors and potentially improve treatment decisions. Additionally, we remain on track for the commercial launch of our two additional skin cancer products – our DecisionDx-SCC gene expression profile (GEP) test for use in patients diagnosed with high risk cutaneous squamous cell carcinoma, and our skin cancer product for

use in patients with a suspicious pigmented lesion – in the second half of 2020. We believe these two late stage pipeline products will increase our estimated total addressable U.S. market by more than $1.4 billion, for an estimated total addressable U.S. market of $2.0 billion for current and pipeline products."

Fourth Quarter Ended December 31, 2019, Highlights

Delivered 4,480 DecisionDx-Melanoma test reports in the 2019 fourth quarter, compared to 3,270 reports during the fourth quarter of 2018, representing an increase of 37% compared to the same period in 2018.

Delivered 434 DecisionDx-UM test reports in the 2019 fourth quarter, compared to 385 reports during the fourth quarter of 2018, representing an increase of 13% compared to the same period in 2018.

Year- Ended December 31, 2019, Highlights

Delivered 15,529 DecisionDx-Melanoma test reports for the full year 2019, compared to 12,032 reports during the full year 2018, representing an increase of 29%.

In 2019, new ordering clinicians for DecisionDx-Melanoma increased 24% year-over-year. Additionally, total ordering clinicians in 2019 for DecisionDx-Melanoma increased 32% to 3,927, year-over-year.

Delivered 1,526 DecisionDx-UM test reports for the full year 2019, compared to 1,413 reports during the full year 2018, representing an increase of 8%. On a combined basis, overall reports increased by 27% for both DecisionDx-Melanoma and DecisionDx-UM for the full year 2019, compared to 2018.

Year-end 2019 cash and cash equivalents balance was approximately $99 million.

More than 1,000 squamous cell carcinoma patients from 56 U.S. centers enrolled in the DecisionDx-SCC clinical validation and performance studies as of December 31, 2019. The Company reported positive data from the clinical validation cohort study (n=321) in October 2019, and expects to report data from the performance cohort in 2020. Castle expects to launch its DecisionDx-SCC gene expression profile (GEP) test for use in patients diagnosed with high risk cutaneous squamous cell carcinoma in the second half of 2020.

More than 1,000 patients were also enrolled in the clinical development, validation and performance cohort studies for Castle’s GEP test for patients with a suspicious

pigmented lesion as of December 31, 2019. The Company expects to announce data from these studies and launch this GEP test in the second half of 2020.

Castle Biosciences has not completed the preparation of its financial statements for the fourth quarter or full -year 2019. The preliminary, unaudited performance results presented in this news release for the quarter and year-ended December 31, 2019, are based on management’s initial review of the information presented and are subject to adjustment based on the completion of the Company’s end-of-period reporting processes and related activities, including the audit of the Company’s financial statements, as such, any financial information contained herein may differ from the information reflected in our financial statements as of and for the year-ended December 31, 2019. Additional information and disclosures would be required for a more complete understanding of the Company’s financial position and results of operations as of and for the quarter and year-ended December 31, 2019. Accordingly, undue reliance should not be placed on this preliminary information.