On March 12, 2020 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported its financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Synlogic, MAR 12, 2020, View Source [SID1234555490]).

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"We have built key Synthetic Biotic platform capabilities in synthetic biology, manufacturing and development to enable the efficient generation of therapeutics that have the potential to address unmet medical need in a range of indications from rare metabolic diseases to cancer," said Aoife Brennan, M.B., Ch.B., Synlogic’s president and chief executive officer. "Building on our experience in our PKU program we have made steady progress on new programs in enteric hyperoxaluria and maple syrup urine disease and we look forward to providing more detail on these initiatives as well as the underlying engine that powers our pipeline as year progresses."

2020 Priorities

Pipeline

Initiation of a Phase 2 clinical trial to evaluate a solid formulation of SYNB1618 in patients with phenylketonuria (PKU) expected in the first half of 2020. The trial is designed to evaluate safety and tolerability of a solid formulation of SYNB1618 as well as its potential to lower blood phenylalanine (Phe) levels in PKU patients. In addition, the study is expected to provide valuable information to validate predictive pharmacodynamic and preclinical modeling.
Evaluation of data expected in 2020 from the monotherapy arm of the Phase 1 clinical study of SYNB1891 in patients with advanced solid tumors or lymphoma. SYNB1891 is an intra-tumorally administered Synthetic Biotic medicine engineered to produce cyclic di-AMP, an agonist of the STING pathway, that is designed to serve as a dual innate activator of the immune system as a potential treatment for solid tumors or lymphoma. SYNB1891 is being evaluated as a monotherapy in an ongoing Phase 1 open-label, multicenter, dose escalation clinical trial (NCT04167137) in patients with advanced solid tumors or lymphoma. Synlogic expects to have data from the monotherapy arm of this study in 2020. After establishing a maximum tolerated dose for SYNB1891 as monotherapy, Synlogic expects to initiate a second arm of the trial in which subjects will receive escalating dose levels of SYNB1891 in combination with a fixed dose of the checkpoint inhibitor, atezolizumab (Tecentriq), to establish a recommended dose for the combination regimen.
Continued development of patient and commercialization-appropriate presentations of SYNB1618. Synlogic has developed and manufactured a solid formulation of its Synthetic Biotic SYNB1618 suitable for future clinical trials and continues to evaluate and develop presentations such as enteric-coated capsules and pressed tablets for eventual commercialization.
Advancement of new Synthetic Biotic programs in metabolic diseases with high unmet medical need. Synlogic is conducting preclinical studies of Synthetic Biotic medicines to treat enteric hyperoxaluria (HOX), an acquired metabolic disorder in which patients develop recurrent kidney stones due to elevated urinary oxalate levels and are at an increased risk of kidney failure. In addition, Synlogic is also developing Synthetic Biotic medicines for the treatment of maple syrup urine disease (MSUD), a rare inherited metabolic disease caused by defective enzymes that metabolize branched chain amino acids (BCAAs) which are components of protein. Elevated blood levels of BCAAs can lead to can lead to seizures, coma, and death. There are currently no approved therapies to treat these disorders.
Presentation and publication of data at major scientific and medical meetings. Synlogic is committed to publishing and presenting data that demonstrate the breadth of Synlogic’s Synthetic Biotic platform.
Corporate

Continued strengthening of Synlogic’s leadership. In January 2020, Synlogic announced the appointment of Michael Burgess, M.B., Ch.B., Ph.D., President, Research & Development, at Turnstone Biologics, to its board of directors. Dr. Burgess is a physician scientist who brings extensive experience in translational drug development from leadership roles at several large Pharma companies including Roche, Bristol-Myers Squibb and Lilly.
Continued exploration of additional strategic collaborations. Synlogic expects to continue to develop strategic collaborations to expand the breadth of its Synthetic Biotic pipeline in therapeutic areas that have high biology risk.
Fourth Quarter 2019 Financial Results

As of December 31, 2019, Synlogic had cash, cash equivalents, and short- and long-term investments of $127.1 million.

For the three months ended December 31, 2019, Synlogic reported a consolidated net loss of $12.8 million, or $0.37 per share, compared to a net loss of $11.9 million, or $0.47 per share, for the corresponding period in 2018.

Research and development expenses were $11.3 million for the three months ended December 31, 2019 compared to $8.9 million for the corresponding period in 2018. The increase in expenses was primarily due to use of synthetic biology services provided under Synlogic’s collaboration with Ginkgo and increased clinical activities, including the SYNB1618 bridging study and initiation of the SYNB1891 Phase 1 clinical study.

General and administrative expenses for the three months ended December 31, 2019 were $3.5 million compared to $4.0 million for the corresponding period in 2018.

Revenue was $1.2 million for the three months ended December 31, 2019 compared to $0.1 million for the three months ended December 31, 2018. Revenue is associated with services performed under the Synlogic’s collaboration with AbbVie to develop a Synthetic Biotic medicine for the treatment of inflammatory bowel disease (IBD). The increase in revenue for the fourth quarter of 2019 compared to the same period in 2018 was a result of revised estimates of time and effort required to reach certain milestones in the collaboration.

Full Year 2019 Financial Results

For the year ended December 31, 2019, consolidated net loss was $51.4 million, or $1.70 per share, compared to a consolidated net loss of $48.4 million, or $2.03 per share, for the year ended December 31, 2018. Revenues were $2.2 million for the year ended December 31, 2019, compared to $2.5 million for the same period in 2018. Total operating expenses were $56.6 million for the year ended December 31, 2019, compared to $53.8 million for the same period in 2018.

Conference Call & Webcast Information

Synlogic will host a conference call and live webcast today at 5:00 p.m. ET today, Thursday, March 12, 2020. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Alternatively, investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or +1 (213) 660-0926 from outside the United States. The conference ID number is 4089293. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors and Media section of the Synlogic website.

On March 12, 2020 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the fourth quarter and full year ended December 31, 2019, and provided a business update on recent corporate and clinical developments (Press release, Protalix, MAR 12, 2020, View Source [SID1234555506]). The Company will discuss the clinical, corporate and financial highlights on a conference call and live webcast, scheduled for Thursday, March 12th, 2020 at 8:30 am EDT.

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"2019 was a pivotal year for Protalix, as we successfully expanded on our strong foundation and entered into a new phase of development as a world-class recombinant therapeutic company," said Dror Bashan, Protalix’s President and Chief Executive Officer. "With this continued forward momentum toward commercialization of our Fabry program, we believe Protalix is positioned for both near- and long-term success," he continued.

"We are increasingly enthusiastic about our PRX-102 asset now that we have three ongoing, fully-enrolled Phase III clinical trials of PRX-102, and as we anticipate our BLA submission to the U.S. Food and Drug Administration under the Accelerated Approval pathway next quarter," added Mr. Bashan. "Furthermore, we anticipate the final results of our BRIDGE and BRIGHT trials in the first and second halves of 2020, respectively, which will further support our portfolio of data regarding PRX-102. Protalix is firing on all cylinders right now, and the energy among the entire staff reached a new pinnacle in 2019."

"We anticipate 2020 to be a banner year for Protalix as we increase our focus on advancing our clinical pipeline, expanding sales in Brazil of Elelyso, our enzyme replacement therapy for the treatment of Gaucher disease, and leveraging commercial opportunities to expand our global footprint in the treatment of Fabry disease," he concluded.

Conference Call and Webcast Information

The Company will host a conference call on Thursday, March 12, 2020, at 8:30 am, Eastern Daylight Time, to review the clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:

Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13699970
Webcast: View Source

The conference call will also be broadcast live and will be available for replay for two weeks in the Events Calendar of the Investors section of the Company’s website, www.protalix.com. Please access the Company’s website at least 15 minutes ahead of the conference call in order to register, download and install any necessary audio software.

2019 Full-Year and Recent Business Highlights

Clinical Advancements

·The Company and its collaboration partner, Chiesi Farmaceutici S.p.A., or Chiesi, plan the submission of a BLA for PRX-102 via the FDA’s Accelerated Approval pathway in the second quarter of 2020, based on data from the completed Phase I/II clinical trial of PRX-102 for the treatment of Fabry disease and the ongoing Phase III BRIDGE clinical trial.
Results from the Company’s Phase I/II clinical trial of PRX-102 were published in an article in the May 2019 edition of the Journal of Inherited Metabolic Disease.

·The Company announced positive 12-month interim on-treatment data from the BRIDGE study. The interim data demonstrate a mean improvement in kidney function in both male and female patients when switched from agalsidase alfa (Replagal) to PRX-102. The data will be included in the anticipated BLA filing to help to support the application.

·The Company and Chiesi announced the completion of enrollment in the Phase III BALANCE clinical trial. The head-to-head BALANCE study is designed to evaluate the safety and efficacy of PRX-102 compared to agalsidase beta (Fabrazyme) on renal function in Fabry patients with progressing kidney disease previously treated with agalsidase beta. To date, more than 66 patients are being treated in the Company’s various extension studies after opting to continue treatment with PRX-102 after completion of an initial study.

·Enrollment was completed in the Phase III BRIGHT clinical trial of PRX- 102, via intravenous infusions of 2 mg/kg administered every 4 weeks. Preliminary pharmacokinetic (PK) data showed PRX-102 to be well-tolerated; and infusion of 2 mg/kg PRX-102 administered every 4 weeks resulted in the presence of continuous active enzyme throughout the entire infusion interval. Infusions every 2 weeks is the current standard of care for the treatment of Fabry disease.

Corporate & Financial Developments

·The Company yesterday successfully secured securities purchase agreements to raise proceeds equal to $43.7 million through a private financing with a number of leading Israeli and U.S.- based investors, including Psagot Investment House, More Investment House, Highbridge Capital, UBS O’Connor, Rosalind Capital, and Alrov Properties and Lodging, among others. Rosario Capital and Houlihan Lokey served as financial advisors in the private placement.

·In December 2019, the Company held a special meeting of stockholders to propose the following two critical financial amendments, which stockholders ultimately approved:
oA reverse stock split (1-for-10); and
oA reduction in the total number of shares of the Company’s common stock that the Company is authorized to issue from 350 million to 120 million shares.

·In December 2019, the Company enhanced its Board of Directors with addition of two accomplished biopharmaceutical executives, Pol F. Boudes, M.D., and Gwen A. Melincoff.

·In August 2019, the Company’s Board of Directors unanimously elected Zeev Bronfeld, an independent director, as Chairman of the Board.

·In July 2019, the Company appointed Eyal Rubin as Senior Vice President and Chief Financial Officer.

·In May 2019, the Company appointed Dror Bashan as President and Chief Executive Officer.

Regulatory Advancements

·In February 2020, Protalix and Chiesi announced the receipt of an agreement letter from the FDA for the Initial Pediatric Study Plan (iPSP) for PRX-102 for the treatment of Fabry disease, outlining an agreed-upon approach to address the needs of pediatric Fabry patients.

Financial Results

For the year ended December 31, 2019, compared to the year ended December 31, 2018

·The Company recorded revenues from selling goods of $15.9 million for the year ended December 31, 2019, an increase of $6.9 million, or 77%, compared to revenues of $9.0 million for the same period of 2018. The increase is primarily due to higher sales of Elelyso in Brazil as well as an increase in sales of drug substance to Pfizer.

·Research and development expenses, net, were $44.6 million for the year ended December 31, 2019, an increase of $11.3 million, or 34%, compared to $33.3 million for the same period of 2018. The increase resulted primarily from an increase of $9.1 million in clinical trial related costs as well as a decrease of $2.1 million in grants received from the Israeli Innovation Authority.

·Selling, general and administrative expenses were $9.9 million for the year ended December 31, 2019, a decrease of $1.0 million, or 9%, compared to $10.9 million for the same period of 2018. The decrease resulted primarily from costs related to the Company’s U.S. Exclusive License and Supply Agreement that the Company entered into in 2018, which were not incurred in 2019.

·Net loss was $18.3 million for the year ended December 31, 2019, or $1.23 per share, basic and diluted, compared to a net loss of $26.5 million, or $1.80 per share, basic and diluted, for the same period of 2018.

·At December 31, 2019, the Company had $17.8 million in cash and cash equivalents.

For the three months ended December 31, 2019, compared to the three months ended December 31, 2018

·The Company recorded revenues from selling goods of $3.8 million during the three-month period ended December 31, 2019, an increase of $2.0 million, or 111%, compared to revenues of $1.8 million for the same period of 2018. The increase is primarily due to higher sales of drug substance to Pfizer Inc. as well as higher sales of Elelyso in Brazil.

·Research and development expenses, net, were $9.6 million for the three-month period ended each of December 31, 2019 and December 31, 2018.

·Selling, general and administrative expenses were $3.0 million for the three-month period ended December 31, 2019, an increase of $0.8 million, or 36%, compared to $2.2 million for the same period in 2018. The increase is primarily due to costs related to the efforts to evaluate and pursue strategic alternatives, business development advisory fees, and legal fees and costs related to replacement of the Chief Executive Officer.

·Net profit for the three months ended December 31, 2019 was $0.3 million, or $0.02 per share, basic and diluted, compared to a net loss of $5.4 million, or $0.40 per share, basic and diluted, for the three months ended December 31, 2018.

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]).

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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.

On March 12, 2020 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the fourth quarter and full year 2019 and provided an operational update (Press release, Bellicum Pharmaceuticals, MAR 12, 2020, View Source [SID1234555491]).

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"Bellicum is at an exciting inflection point as we continue to validate the GoCAR platform and explore its utility more broadly," said Rick Fair, President and Chief Executive Officer of Bellicum. "We recently presented promising new translational data from the BPX-601 Phase 1 study, and we intend to present an update later this year on safety and preliminary activity in pancreatic cancer using repeated BPX-601 GoCAR-T activation with rimiducid. We have also expanded utilization of our GoCAR platform by initiating our first off-the-shelf GoCAR-NK program. In 2020, we look forward to the progress we expect to make applying our platform to solid tumor and off-the-shelf cell therapies."

PROGRAM HIGHLIGHTS AND CURRENT UPDATES
BPX-601 GoCAR-T

Bellicum presented new Phase 1 translational data for BPX-601 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco in January 2020. Primary observations included tumor infiltration, GoCAR-T mediated immunomodulation, survival and persistence of cells for up to nine months, and changes in the tumor microenvironment gene expression consistent with a productive CAR-T cell immune response.

Bellicum is currently enrolling cohort 5C of this trial to collect data to evaluate the safety of repeat rimiducid dosing to re-activate GoCAR-T cells over time, the first-in-human experience using the GoCAR platform as intended. Initial results from Cohort 5C are expected to be presented at a medical meeting by the end of 2020.

BPX-603 GoCAR-T

In response to Bellicum’s IND application for BPX-603, the FDA requested additional nonclinical data to further characterize this product candidate. Non-clinical experiments to generate the data are underway. Management expects to provide an update on its progress for this program in the third quarter of 2020.

BCMA GoCAR-NK Program

Bellicum recently initiated formal preclinical development activities for its GoCAR-NK program targeting B-cell maturation antigen, or BCMA, for the treatment of multiple myeloma. Bellicum presented a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2019 that included preclinical data that suggest the GoCAR platform may enhance NK cell proliferation, persistence, and cytotoxicity, potentially improving their utility as an off-the-shelf cancer therapy. Specifically, Bellicum believes that GoCAR-NK may improve the durability of clinical responses while offering the anticipated advantages that an allogeneic, off-the-shelf product may provide, including faster and more certain time to treatment, greater scalability and convenience, and potentially lower cost.

Management expects to present additional preclinical data for this program by the end of 2020.

Corporate Highlights

In January 2020, Bellicum entered into an asset purchase agreement under which The University of Texas MD Anderson Cancer Center will acquire Bellicum’s approximately 60,000-square-foot Houston facility, including manufacturing, office and laboratory space, for $15.0 million. As part of the transaction, Bellicum will also enter into a master services agreement with MD Anderson. Following completion of the transaction, MD Anderson will operate the Houston facility for its own internal programs as well as to manufacture Bellicum’s GoCAR and other cellular therapy programs for clinical trials and potentially early commercial supply.

In December 2019, Bellicum licensed its CaspaCIDe safety switch to MD Anderson for use in its CD19 CAR-NK program. Under terms of the original license agreement, MD Anderson exercised its option to non-exclusively license the technology for this construct and subsequently sublicensed it to a third party for future development. These actions entitled Bellicum to receive an upfront payment of $5 million and undisclosed future milestone payments and royalties on sales.

Fourth Quarter and Full Year 2019 Financial Results and Outlook
Revenue: Bellicum reported revenue of $5.1 million and $7.1 million for the fourth quarter and year ended December 31, 2019, respectively compared to $0.3 million and $1.1 million during the comparable periods in 2018. The increase in revenues in the fourth quarter and full year 2019 compared to the respective periods in 2018 were primarily due to a $5.0 million license fee received from MD Anderson for the non-exclusive license to the CaspaCIDe safety switch.
R&D Expenses: Research and development expenses were $13.3 million and $64.5 million for the fourth quarter and year ended December 31, 2019, respectively, compared to $19.9 million and $71.6 million during the comparable periods in 2018. The reduction in expenses in the fourth quarter and full year 2019 compared to respective periods in 2018 were primarily due to reduced expenses related to rivo-cel, reductions in general R&D expenses, and reduced employee salary-related charges from the reduction in force that was implemented during the second half of 2019, partially offset by the impairment of the intangible asset previously recorded from the Miltenyi Supply Agreement, increased expenses related to our GoCAR-T program, and employee severance costs arising from the reduction in force.
G&A Expenses: General and administrative expenses were $5.7 million and $30.0 million for the fourth quarter and year ended December 31, 2019, respectively, compared to $7.0 million and $25.0 million during the comparable periods in 2018. The reduction in expenses in the fourth quarter of 2019 relative to the comparable period in 2018 was primarily due to a decrease in personnel costs and share-based compensation from the reduction in force that was implemented during the second half of 2019. The increase in G&A expenses for the year ended December 31, 2019, compared to the year ended December 31, 2018, was primarily due to an increase in personnel costs and commercialization activities during the first half of 2019, partially offset by a reduction in rivo-cel related commercialization activities as well as the effects of the reduction in force that reduced employee salary-related charges.

Loss from Operations: Bellicum reported a loss from operations of $13.9 million and $87.4 million for the fourth quarter and year ended December 31, 2019, respectively, compared to a loss from operations of $26.6 million and $95.5 million for the comparable periods in 2018.
Cash used in operating activities was $12.7 million and $77.6 million for the fourth quarter and year ended December 31, 2019, respectively, compared to cash used in operating activities of $20.4 million and $74.8 million for the comparable periods in 2018.
Net Loss: Bellicum reported a net loss of $29.0 million and $112.5 million for the fourth quarter and year ended December 31, 2019, respectively, compared to a net loss of $27.2 million and $98.0 million for the comparable periods in 2018. The results included non-cash expense of $14.3 million and $19.2 million related to the change in fair value of warrant liability in the fourth quarter and year ended December 31, 2019, respectively.
Shares Outstanding: In February, Bellicum effected a reverse stock split of its issued and outstanding common stock, at a ratio of 1-for-10. As of February 28, 2020, Bellicum had 5,047,892 shares of common stock outstanding and 534,200 shares of preferred stock outstanding. Each preferred share can be converted into 10 shares of common stock.
Cash Position and Guidance: Based on current operating plans, Bellicum expects that current cash resources will be sufficient to meet operating requirements into the second half of 2021. Management expects cash utilization of $55 to $65 million in 2020. Bellicum reported cash and cash equivalents, restricted cash and investments totaling $93.8 million as of December 31, 2019, compared to $106.9 million as of September 30, 2019.

Conference Call and Webcast
Bellicum’s management will host a webcast and conference call today at 5 p.m. ET / 2 p.m. PT, March 12, 2020, to discuss the financial results for the fourth quarter 2019 and provide a corporate update. The live call may be accessed by dialing (877) 407-3103 for domestic callers and (201) 493-6791 for international callers. A live webcast of the call will be available from the Investors and Media section of the company’s website at www.bellicum.com and a replay will be available shortly after the live event.

On March 12, 2020 Merck & Co reported that the rejection, which would have been for adults who have had platinum-containing chemotherapy, comes after a review of new evidence collected while the MSD blockbuster was available via the Cancer Drugs Fund.

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NICE says that there is still uncertainty surrounding the long-term benefit of the second-line immunotherapy treatment in comparison with other options, meaning it is not a "cost-effective use of NHS resources at its current price."

The organisation says that the drug will be withdrawn from the Cancer Drugs Fund once final guidance has been published, meaning that no new patients will be offered the treatment, although it will not affect those whose treatment was started before the final guidance was published.

As it stands, the list price for Keytruda is £2,630 per 100mg vial, which would be given as 200mg intravenously every three weeks. Even when the drug is offered with its agreed discount, the most plausible cost-effectiveness estimate remains above what NICE normally considers acceptable, even for end-of-life treatments.

The rejection marks the second NICE ‘no’ for MSD and Keytruda in the last month or so, as the organisation released a draft guidance rejecting the drug in combo with Pfizer’s Inlyta (axitinib) to treat advanced renal cell carcinoma in February.

Urothelial cancer begins in the lining of the bladder and is thought to be caused by prolonged exposure to harmful substances such as those found in tobacco smoke. It is the most common form of bladder cancer and accounts for nine in 10 of all cases.