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Harbour BioMed Raises $75 Million Series B+ Venture Capital Financing To Accelerate Its Innovative Pipeline

On March 12, 2020 Harbour BioMed (HBM) reported successful completion of its Series B+ round financing of $75 million to accelerate the advancement of its clinical-stage compounds and growing portfolio of next generation biotherapeutics for treating cancer and immunological diseases (Press release, Harbour BioMed, MAR 12, 2020, View Source [SID1234555477]). New investors participating in the financing – SK Holdings, Greater Bay Area Fund, Efung Capital, Zheshang Venture Capital and Zhejiang University Future Capital and JT New Century – joined existing investors, including Legend Capital, AdvanTech and GIC Pvt. Ltd. The company previously completed an $85 million Series B financing in August 2018.

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The funds from the Series B+ will help drive these programs towards key clinical and development milestones. This round of financing further underscores both company’s existing and new investors’ confidence in HBM, and the team’s ability to execute with conviction and commitment.

"Over the past several months, HBM has made great progress in advancing two leading assets towards mid-late stage clinical trials in China, and we began international clinical studies with our first internally-discovered biotherapeutic, a next generation, fully-human anti-CTLA-4 antibody (HBM4003) for the treatment of advanced solid tumors," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "Our discovery efforts have also been extremely productive, both internally and in collaboration with leading organizations around the world. In addition to HBM4003, our innovative discovery platform HBICETM has rapidly generated a robust portfolio of differentiated, fully human antibodies, including next generation bi-and multi-specifics. More recently, we have leveraged the power of our antibody discovery platform in select other areas of great unmet medical needs, such as in coronavirus disease (COVID-19), where we have entered a collaboration with Mount Sinai Heath System in New York".

The Company recently reported on major progress in its clinical development programs, including:

· Start of Phase 1 clinical studies with HBM4003 for the treatment of advanced solid tumors. HBM4003, a next generation anti-CTLA 4 therapeutic, is the first fully human antibody based on HBM’s heavy chain only (HCAb) antibody discovery technology. The trial, underway in Australia, is the first in an international development program that will inaugurate trials in the US, EU and China. HBM recently received IND approval from the FDA to initiate its trial in the US. HBM4003 has shown potential in preclinical studies for increased anti-tumor activity based on enhanced antibody dependent cell toxicity mediated Treg depletion and a favorable safety profile.

· Start of Phase 2/3 clinical trials of HBM 9161, an anti-FcRn antibody, for the treatment of multiple severe, autoimmune diseases including myasthenia gravis, adult immune thrombocytopenia, Graves’ ophthalmology and other related indications. Phase 2/3 studies for several of these indications are expected to begin in the first half of 2020 in Greater China.

· Successful completion of a Phase 2 trial of HBM 9036 for Dry Eye Disease. HBM is preparing to start a Phase 3 registration trial in Q2 2020 in China.

· Start of Phase 2 clinical trials of HBM9167, its humanized IgG1 monoclonal antibody targeting programmed death-ligand 1 (PD-L1), for the treatment of nasopharyngeal cancer (NPC). The US FDA granted HBM9167 Orphan Drug Designation (ODD) for the development in treating NPC.

HBM has built a powerful drug discovery engine based on its patented HCAb platform for generating novel, fully human heavy chain only antibodies, including bi- and multi-specifics. The technology is integrated with other advanced approaches – e.g., single cell analysis and deep profiling— to dramatically reduce the time to candidate selection from months to days.

F1 Oncology Changes Name To EXUMA Biotech; Announces New Round Of Financing To Advance Cellular Therapies

On March 12, 2020 EXUMA Biotech Corp. (formerly F1 Oncology), a clinical-stage biotechnology company discovering and developing CAR-T therapies for solid and liquid tumors, reported a $19M Series B round of financing that includes new investments by MSD Partners and F1 BioVentures, as well as conversion of notes held by individual investors (Press release, EXUMA Biotechnology, MAR 12, 2020, View Source [SID1234555463]).

EXUMA Biotech Corp. and its affiliates will be utilizing these proceeds to advance new logic gated CAR-T therapies for solid tumor malignancies as well as for further development and partnering of its rapid point-of-care (or "rPOC"), same-day CAR-T platform technology.

Additionally, the company has now aligned management with its international subsidiaries under one cohesive global organization (www.exumabio.com), to better reflect its new business model. "We are now moving forward together as one company. The timing was right for us to create a unified global platform to leverage our synergistic capabilities, which we believe will ultimately allow us to produce and deliver CAR-T products even more efficiently for the millions of people worldwide in need of cutting-edge treatments in their fight against cancer," said Gregory Frost, Ph.D., Chairman and CEO of EXUMA Biotech Corp.

The name change coincides with the addition of two new directors, Scott Segal and Frank McCormick, who join existing directors David Ramsay and Gregory Frost. "We are pleased to welcome these new Directors to the EXUMA board; their collective experience will be invaluable as we advance through several key inflection points in 2020," said Dr. Frost. "This will be a tremendous year for the company as we continue development of these exciting new platforms, especially rPOC, which can help make cellular therapies more readily accessible to patients around the world."

Scott Segal is a Managing Director at MSD Partners ("MSD"), where he invests across a range of sectors, in both debt and structured equity. He joined MSD in 2006 from the Boston Consulting Group, where he provided consulting services to Fortune 500 executives. Prior to the Boston Consulting Group, Mr. Segal worked at HarbourVest Partners and Salomon Brothers.

Frank McCormick, Ph.D., F.R.S., D.Sc. (Hon) currently serves as a Professor at the UCSF Helen Diller Family Comprehensive Cancer Center. Prior to this, Dr. McCormick pursued cancer-related work and held positions with several Bay area biotechnology firms, including Cetus and Chiron Corporations. In 1992, he founded Onyx Pharmaceutics, where as CSO he initiated drug discovery efforts that led to the approval of Sorafenib in 2005 for treatment of renal cell cancer, and for liver cancer in 2007. Currently, he leads the NCI’s Ras Initiative, where he oversees developmental therapies against Ras-driven cancers, which include many pancreatic, colorectal, and lung cancers. Dr. McCormick is the author of over 300 scientific publications.

Selecta Biosciences Reports Fourth Quarter 2019 and Year-End Financial Results

On March 12, 2020 Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform, ImmTOR, reported financial results for the fourth quarter and year ended December 31, 2019 (Press release, Selecta Biosciences, MAR 12, 2020, View Source [SID1234555462]).

"2019 was a pivotal year for Selecta. We made substantial clinical advancements, as we completed enrollment in the head-to-head COMPARE trial for our lead product candidate, SEL-212, in chronic refractory gout, and advanced our gene therapy program through strategic partnerships with AskBio. We also strengthened our organization with the addition of several key members to the executive team and welcomed a new Chairman of our Board of Directors, and completed a $70 million financing," said Carsten Brunn, Ph.D., President and CEO of Selecta. "In the coming year, we look forward to reporting topline data from the COMPARE study, commencing the Phase 3 clinical program of SEL-212, and advancing our gene therapy program into the clinic in partnership with AskBio."

Recent Highlights and Anticipated Upcoming Milestones:

Topline Results from COMPARE Clinical Trial Expected in the Third Quarter of 2020: In December 2019, we announced the completion of enrollment in the head-to-head COMPARE study of Selecta’s lead product candidate, SEL-212 (ImmTOR + pegadricase), vs. pegloticase. Topline data from this trial is expected in the third quarter of 2020. The trial is evaluating a once-monthly dose of SEL-212 compared to biweekly doses of pegloticase, with the primary endpoint of the maintenance of serum uric acid (SUA) levels of <6mg/dL at three and six months.

Meeting with FDA Provides Clarity on Phase 3 Clinical Program of SEL-212: Selecta held a meeting with the U.S. Food and Drug Administration (FDA) in January 2020 to inform the design of the planned Phase 3 clinical program. Selecta plans to commence its Phase 3 clinical program of SEL-212 against placebo in the second half of 2020.

Gene Therapy Program in the Clinic by the End of 2020: In August 2019, Selecta announced a strategic partnership with Asklepios BioPharmaceutical, Inc. (AskBio), to jointly develop, manufacture, and commercialize a broad portfolio of next-generation AAV gene therapies. This

partnership will leverage the unique proprietary technology platforms of both companies with a human proof of concept trial to validate this portfolio of products and their potential for re-dosing in patients, which could represent a significant advancement in the gene therapy field. Selecta and AskBio anticipate entering the clinic by the end of 2020. Additionally, the Company intends to advance its proprietary program in ornithine transcarbamylase (OTC) deficiency.

Broadened Strategic Partnership with AskBio: In December 2019, Selecta and AskBio jointly announced that the companies entered into a license agreement under which AskBio exercised its option to exclusively license rights to develop and commercialize Selecta’s immune tolerance platform, ImmTOR, for use in adeno-associated virus (AAV) gene therapy for the treatment of Pompe disease. Affecting 5,000-10,000 people worldwide, Pompe disease is a rare, genetic, lysosomal storage disease characterized by the abnormal buildup of a sugar molecule called glycogen inside cells. Under the terms of the agreement, Selecta received upfront payments of $7 million and is eligible to receive milestone payments of $237 million plus royalties on product sales.

Raised $70 Million in a Private Placement: In December 2019, Selecta announced the closing of a transaction to sell securities in a private placement with institutional investors and certain members of the Company’s Board of Directors, resulting in gross proceeds of approximately $70 million.

Strengthened Board of Directors: In November 2019, Selecta announced the appointment of Carrie S. Cox to the position of Chairman of the Board of Directors. A renowned industry leader and successful biopharmaceutical executive, Ms. Cox has served on multiple Boards, and has held the position of Chair, for several biopharmaceutical companies.

Fourth Quarter and Full Year 2019 Financial Results:

Cash Position: Selecta had $91.6 million in cash, cash equivalents, and restricted cash as of December 31, 2019, which compares to cash, cash equivalents, restricted cash, and short-term investments of $35.9 million as of September 30, 2019. Selecta believes its available cash, cash equivalents, and restricted cash will be sufficient to meet its operating requirements into the first quarter of 2021.

Net cash used in operating activities was $12.9 million and $51.4 million for the fourth quarter and fiscal year 2019, respectively, as compared to $12.7 million and $59.2 million for the same periods in 2018.

Research and Development Expenses: Research and development expenses for the fourth quarter and fiscal year 2019 were $15.2 million and $42.7 million, respectively, which compares with $10.3 million and $47.7 million for the same periods in 2018. The quarterly increase reflects additional costs incurred specific to our Phase 2 head-to-head (COMPARE) clinical trial of SEL-212, for which we completed enrollment in December 2019. The decrease year over year reflects reduced costs in 2019 due to the completion of prior programs in 2018, combined with reduced salaries and benefits resulting from the headcount reduction in early 2019. The cost reductions were offset by an overall increase in costs incurred on our lead product candidate, SEL-212.

General and Administrative Expenses: General and administrative expenses for the fourth quarter and fiscal year 2019 were $4.1 million and $16.4 million, respectively, which compares with $5.1 million and $18.2 million for the same periods in 2018. The decrease is the result of lower salaries and stock compensation expense resulting from reduced headcount at the end of 2018, combined with reduced patent and professional fees.

Net Loss: For the fourth quarter and fiscal year 2019, Selecta reported a net loss of $14.9 million, or $0.28 per share and $55.4 million, or $1.22 per share, compared to a net loss of $14.7 million, or $0.65 per share, and $65.3 million, or $2.92 per share, for the same periods in 2018.

Conference Call and Webcast Reminder:
Selecta management will host a conference call at 8:30 AM ET today to provide a corporate update and review the company’s fourth quarter 2019 financial results. Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10138603. Investors and the public can access the live and archived webcast of this call and a copy of the presentation via the Investors & Media section of the company’s website, www.selectabio.com.

Nurix Therapeutics Closes $120 Million Financing to Advance Targeted Protein Modulation Drug Pipeline

On March 12, 2020 Nurix Therapeutics, Inc., a company developing targeted protein modulation drugs, reported it has closed an oversubscribed $120 million financing (Press release, Nurix Therapeutics, MAR 12, 2020, View Source [SID1234555461]). The round was led by Foresite Capital with participation from Bain Capital Life Sciences, Boxer Capital (Tavistock Group), EcoR1 Capital, Redmile Group, Wellington Management Company and an undisclosed investor, as well as Nurix’s founding investors The Column Group and Third Rock Ventures.

"With the funds raised in this financing, Nurix is well positioned to bring its targeted protein modulation therapeutics into the clinic," said Arthur Sands, M.D., Ph.D., chief executive officer of Nurix Therapeutics. "We will also continue to use our powerful DELigase platform to discover new therapies aimed at previously undruggable targets of high therapeutic potential."

Proceeds from the financing will enable the company to advance Nurix’s wholly owned development candidates into clinical development. The leading edge of Nurix’s pipeline includes an orally delivered BTK chimeric targeting molecule (CTM) for B cell malignancies for which the Company expects to file an IND application with the FDA by the end of the year. The second molecule in Nurix’s preclinical pipeline is an orally delivered inhibitor of the CBL-B ligase for stimulation of T cell activation and IL-2 secretion as a novel immuno-oncology agent. Both development candidates were derived from Nurix’s DELigaseTM targeted protein modulation platform, which combines the use of DNA-encoded libraries (DEL) with an expanding set of E3 ligases to achieve targeted protein modulation. Nurix’s scientific approach enables either the harnessing of E3 ligases to degrade specific target proteins, as in the case of the BTK CTM, or the inhibition of specific ligases to raise substrate protein levels, as in the case of the CBL-B inhibitor.

"Nurix’s CTM and DELigaseTM platform technologies have led to the discovery of novel BTK degraders with the potential to transform the treatment landscape for hematological indications," said Michael Rome, Ph.D., partner at Foresite Capital. "Their differentiated platform and novel approach have resulted in strategic corporate partnerships and we believe position the company as a leader in the emerging protein modulation field."

In addition to advancing its wholly owned pipeline, Nurix recently formed two new strategic collaborations with Sanofi and Gilead to develop novel protein degradation therapies in multiple therapeutic areas. Together, these collaborations provided Nurix with $100 million in upfront payments and the potential for over $4.5 billion in milestones with additional royalties and certain co-development options.

Curis to Release Fourth Quarter and Year-End 2019 Financial Results and Hold Conference Call on March 19, 2020

On March 12, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the Company will release its fourth quarter and full-year 2019 financial results on Thursday, March 19, 2020, after the close of US markets. Management will host a conference call on the same day at 4:30 p.m. ET (Press release, Curis, MAR 12, 2020, View Source [SID1234555460]).

To access the live conference call, please dial (888) 346-6389 from the United States or (412) 317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the ‘Investors’ section. A replay of the financial results conference call will be available on the Curis website shortly after completion of the call.