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PRESS RELEASE Bolt Biotherapeutics To Present Preclinical Proof of Concept Data at American Association for Cancer Research (AACR) Conference

On February 27, 2019 Bolt Biotherapeutics, Inc., a biotechnology company focused on unleashing the power of the immune system to achieve anti-tumor immunity in patients with its promising Immune-Stimulating Antibody Conjugate (ISAC) platform, reported the forthcoming presentation of preclinical data on its BoltbodyTM technology at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference (Press release, Bolt Biotherapeutics, FEB 27, 2019, View Source [SID1234533828]). The conference will be held March 29th through April 3rd in Atlanta, Georgia.

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Details relating to the presentation are as follows:
Abstract Title: TLR7/8 immune-stimulating antibody conjugates elicit robust myeloid activation leading to enhanced effector function and antitumor immunity in pre-clinical models.
Abstract Number: 1559
Date and Time: Monday, April 1, 2019, 8am – 12pm EDT
Session Category: Immunology Session Title: Therapeutic Antibodies
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 25, Poster Board 28

"We are pleased that the first public presentation of our BoltbodyTM technology will occur at the AACR (Free AACR Whitepaper) Annual Meeting," stated David Dornan, Ph.D., senior vice president of research at Bolt Biotherapeutics. "BoltbodyTM ISACs are a new class of therapeutics that harness the ability of toll-like receptor (TLR) agonists to convert cold tumors into immunologically hot tumors following systemic administration. We are rapidly advancing our lead BoltbodyTM therapeutic toward the clinic based upon the promising data."

"It is exciting to share the encouraging data generated by this unique technology which builds upon our growing understanding of the role of myeloid cells in generating effective anti-tumor immunity. Our poster will cover in vitro and in vivo data demonstrating that BoltbodyTM ISACs have the capacity to eliminate tumors in preclinical models," stated Ed Engleman, M.D., Bolt founder and co-director of the Immunology and Immunotherapy Research Program at the Stanford Cancer Institute.

About Bolt Biotherapeutics’ Immune-Stimulating Antibody Conjugate (ISAC) Platform Technology
The Boltbody platform consists of Immune-Stimulating Antibody Conjugates (ISAC) that harness the ability of TLR agonists to convert cold tumors into immunologically hot tumors (illuminating tumors to the immune system allowing them to be invaded by tumor killing cells). BoltbodyTM ISACs have demonstrated the ability to eliminate tumors following systemic administration in preclinical models and have also led to the development of immunologic memory.

CRISPR Therapeutics Announces Presentations at the American Association for Cancer Research 2019 Annual Meeting

On February 27, 2019 CRISPR Therapeutics (NASDAQ: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of the CRISPR team will present two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held March 29 to April 3, 2019, at the Georgia World Congress Center in Atlanta, GA (Press release, CRISPR Therapeutics, FEB 27, 2019, View Source [SID1234533813]).

Title: Allogeneic CRISPR/Cas9 gene-edited CAR-T cells targeting CD33 show potent preclinical activity against AML cells (abstract #1428, poster)
Time and Date: Monday, April 1, 2019, from 8:00 a.m. to 12:00 p.m. ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 21

Title: Targeting multiple solid tumor types with anti-CD70 allogeneic CAR-T cells (abstract #3184, poster)
Time and Date:Tuesday, April 2, 2019, from 8:00 a.m. to 12:00 p.m. ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 22

OPKO Health Reports 2018 Fourth Quarter Business Highlights and Financial Results

On February 27, 2019 OPKO Health, Inc. (NASDAQ: OPK) reported business highlights and financial results for the three months ended December 31, 2018 (Press release, Opko Health, FEB 27, 2019, View Source [SID1234533812]).

Business Highlights

RAYALDEE total prescriptions reported by IQVIA increased 166% in 4Q 2018 compared with 4Q 2017: Total prescriptions were approximately 9,300 during the fourth quarter of 2018. As of January 1, 2019, approximately 80% of prospective U.S. patients have access to RAYALDEE under their insurance plans. The Company continues to increase its commercial reach through expansion of its sales force.
Topline data from the global Phase 3 clinical trial for hGH-CTP in growth hormone deficient children is expected by the end of 2019; Enrollment completed in Japanese registration study: The global pediatric study is a pivotal, non-inferiority design comparing a single weekly administration of hGH-CTP with daily injections of a currently marketed growth hormone product. The global and Japanese pediatric studies utilize the pen device and formulation that will be launched commercially upon approval. The pediatric segment represents more than 80% of the commercial market for treatment of hGH deficiency.
RAYALDEE line extension trial initiated in hemodialysis patients with SHPT: Together with its partners, Vifor Fresenius and Japan Tobacco, OPKO is developing RAYALDEE for patients with Stage 5 CKD who have secondary hyperparathyroidism (SHPT) and vitamin D insufficiency and are undergoing regular hemodialysis. A Phase 2 trial in this population is currently underway in the United States.
Topline data from the Phase 2b study with OPK88003, a once-weekly oxyntomodulin dual GLP1-Glucagon agonist for type 2 diabetes and obesity, is anticipated during 1Q 2019: The last patient, last visit of this Phase 2b dose-escalation study occurred in February 2019. In an earlier, 420-patient Phase 2 trial in patients with type 2 diabetes, OPK88003 was similar to exenatide extended-release (Ex ER) in reducing HbA1c levels. OPK88003 showed statistically significantly greater weight loss and lowering of total cholesterol and triglycerides compared to once-weekly Ex ER, with a good safety profile.
Appointed Jon R. Cohen, M.D. Executive Chairman and promoted Geoff Monk as President, both for BioReference Laboratories: Dr. Cohen brings more than 30 years of healthcare experience as a seasoned strategic leader with extensive and diverse experience; his track record of expanding existing business and developing new ventures, while dealing effectively with the payor universe, is well recognized in the diagnostics industry.
4Kscore utilization remained strong during 4Q 2018 with nearly 20,000 tests performed: The 4Kscore test is a blood test that gives a man with elevated prostate specific antigen (PSA) levels a personalized prediction of his chance of having or developing an aggressive form of prostate cancer. The Company is pursuing U.S. Food and Drug Administration (FDA) approval with a submission expected in the first half of 2019. OPKO announced on January 31, 2019 that Novitas Solutions, Inc. issued a notice of a future non-coverage determination for 4Kscore effective March 20, 2019. The Company is currently making efforts to have the determination rescinded or reversed.
FDA approved Claros point-of-care (POC) PSA test: On February 1, 2019, OPKO announced that the FDA approved the Company’s point-of-care Sangia Total PSA Test using the Claros 1 Analyzer. The Company is taking steps to obtain CLIA waiver for the test and analyzer, which would permit the test to be performed by most medical office personnel with minimal training, and is also planning for scale up of manufacturing capacity during 2019. OPKO plans to expand the testing menu and the next test under development is testosterone, with clinical trials currently scheduled to commence in mid-2019.
Financial Highlights

Net loss for the fourth quarter of 2018 of $76.1 million compared to $217.9 million for the comparable quarter of 2017. Net loss for both periods included unusual or non-cash items consisting of:

During the fourth quarter of 2018, the Company recorded $21.8 million of non-cash impairment to Goodwill and in-process research and development related to its active pharmaceutical ingredient business and the suspension of the Phase 2b clinical trial for its selective androgen receptor antagonist for benign prostatic hyperplasia. In the comparable period of 2017, the Company recorded a $13.2 million impairment resulting from the discontinuation by its licensee of the intravenous formulation of VARUBI;

During the fourth quarter of 2018, the Company incurred approximately $8.0 million of expenses related to defense and investigation of actions brought by the U.S. Securities and Exchange Commission (SEC) and related civil lawsuits. The Company reached a settlement agreement with the SEC in the fourth quarter of 2018, which was finalized in January 2019; and

During the fourth quarter of 2017, the Company recorded $73.3 million of adjustments to revenue from services.

Consolidated revenues for the fourth quarter of 2018 were $221.9 million compared with $161.0 million for the comparable period of 2017. During the 2018 quarter, revenue from services was $183.1 million, revenue from products was $25.4 million, including RAYALDEE revenue of $6.0 million, and revenue from licensing and intellectual property was $13.4 million.
During the fourth quarter of 2018, total operating expenses were $311.9 million, including the aforementioned impairment charges of $21.8 million as well as continued investment in the Company’s pharmaceutical pipeline, with R&D expense of $33.3 million.
The Company recorded a $28.3 million income tax benefit during the fourth quarter of 2018 primarily as a result of valuation allowance releases in foreign jurisdictions. The comparable period of 2017 includes a $61.2 million income tax provision, principally as a result of the Tax Cuts and Jobs Act ($31.8 million) as well as recording a valuation allowance against U.S. based deferred tax assets.
Subsequent to the close of the fourth quarter, on February 5, 2019, OPKO completed the sale of $200 million aggregate principal amount of 4.5% Convertible Senior Notes due 2025.
CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time today. The conference call dial-in and webcast information is as follows:

DOMESTIC DIAL-IN: 866-634-2258
INTERNATIONAL DIAL-IN: 330-863-3454
PASSCODE: 4254518
WEBCAST: View Source

For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 4254518. The replay can be accessed for a period of time on OPKO’s website at View Source

FibroGen Reports Fourth Quarter and Full Year 2018 Financial Results

On February 27, 2019 FibroGen, Inc. (NASDAQ: FGEN), a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics, reported financial results for the fourth quarter and full year 2018 and provided an update on the company’s recent developments (Press release, FibroGen, FEB 27, 2019, View Source;p=irol-newsArticle&ID=2389325 [SID1234533811]).

Thomas B. Neff, FibroGen’s Chief Executive Officer, said, "FibroGen achieved a number of remarkable clinical and regulatory milestones in 2018. We received approval in China for roxadustat, a first-in-class treatment for anemia associated with chronic kidney disease for patients on dialysis in December 2018. Roxadustat will be the first HIF-PH inhibitor to be made available to CKD dialysis patients in need of anemia treatment.

"Following the release of positive efficacy data from our Phase 3 program, our team is now preparing for the submission of our U.S. NDA to the FDA in 2019. In addition, we were granted Fast Track designation from the FDA for pamrevlumab in idiopathic pulmonary fibrosis and in pancreatic cancer in 2018. Our team is focused on commencing Phase 3 clinical studies in both of these indications."

Recent Developments and Highlights
Roxadustat for CKD Anemia in U.S./ROW

FibroGen announced positive topline results from three U.S./EU Phase 3 trials of roxadustat for the treatment of anemia in patients with chronic kidney disease (CKD)
Our partner AstraZeneca announced positive topline results from two global Phase 3 trials of roxadustat for the treatment of anemia in patients with CKD
Our partner Astellas announced that roxadustat met its primary endpoint in its three Phase 3 trials of roxadustat for the treatment of anemia in patients with CKD
Roxadustat for CKD Anemia in China

Received marketing authorization from the National Medical Products Administration (NMPA) for roxadustat for the treatment of anemia caused by CKD in patients who are dialysis-dependent, including hemodialysis and peritoneal dialysis, triggering a total of $12 million in related milestone payments to FibroGen
Clinical results from two Phase 3 studies conducted in China were presented at the American Society of Nephrology (ASN) Kidney Week 2018 in a clinical late-breaking poster session
Roxadustat for CKD Anemia in Japan

Astellas announced positive topline results from the four Phase 3 dialysis-dependent studies
Astellas filed a New Drug Application (NDA) for roxadustat for anemia associated with dialysis-dependent CKD with the Pharmaceuticals and Medical Devices Agency (PMDA), triggering a $15 million milestone payment to FibroGen
Clinical results from two of the four Japan Phase 3 trials in dialysis-dependent patients were presented at the ASN Kidney Week 2018:
Phase 3 trial results in peritoneal dialysis patients presented in an oral session
Results of a Phase 3 darbepoetin alfa-controlled study in stable hemodialysis patients previously treated with ESA presented in a clinical late-breaking poster session
Roxadustat for MDS Anemia

Patient dosing ongoing in both a U.S./Europe Phase 3 study and a China Phase 2/3 study
Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)

Granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with idiopathic pulmonary fibrosis (IPF)
Presented positive Phase 2b efficacy and safety results (improvements in lung function (FVC), quantitative measure of fibrosis (HRCT) and quality of life (SGRQ)) in multiple poster presentations at the American Thoracic Society (ATS) 2018 Conference
Clinical and preclinical data presented at the European Respiratory Society International Congress (ERS) 2018 and 20th International Colloquium on Lung and Airway Fibrosis (ICLAF) 2018
Pamrevlumab for Pancreatic Cancer

Granted Fast Track designation by the FDA for the treatment of patients with unresectable locally advanced pancreatic cancer (LAPC)
Positive Phase 2 clinical trial results presented for presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Pamrevlumab for Duchenne Muscular Dystrophy

Completed Phase 2 clinical trial enrollment in the first quarter of 2018
Corporate and Financial

Net income for the fourth quarter of 2018 was $21.0 million, or $0.25 per basic share and $0.23 per diluted share, compared to a net loss of $33.9 million, or $0.41 net loss per basic and diluted share one year ago
Net loss for the year ended December 31, 2018, was $86.4 million, or $1.03 per share, compared to $120.9 million, or $1.66 per share one year ago
At December 31, 2018, FibroGen had $747.2 million in cash, restricted time deposits, cash equivalents, investments, and receivables, compared to $762.2 million at year-end 2017
The weighted average number of common shares used to calculate net loss per share was 84.1 million shares and 73.0 million shares for the years of 2018 and 2017, respectively
Total shares outstanding as of December 31, 2018 were 85.4 million shares
2019 Outlook
Roxadustat

Approval to treat non-dialysis-dependent CKD patients in China is expected in mid-2019
Regulatory decision on the treatment of dialysis-dependent CKD patients in Japan is expected in the second half of 2019
Full MACE adjudication procedures from our roxadustat Phase 3 studies for the NDA and MAA are expected to be completed in the first half of 2019
Submission of our U.S. NDA for the treatment of anemia associated with CKD to the FDA is anticipated in the third quarter of 2019; and we expect our partner Astellas to submit a marketing authorization application (MAA) to the European Medicines Agency (EMA) thereafter
In MDS, we plan to advance roxadustat into the double-blind, placebo-controlled pivotal portion of our U.S./EU Phase 3 study
In chemotherapy-induced anemia, we expect to start enrolling patients in our Phase 2 clinical study in the U.S. in 2019
Pamrevlumab

On track to start a randomized, double-blind, placebo-controlled pivotal Phase 3 study evaluating pamrevlumab in combination with gemcitabine and nab-paclitaxel as a neoadjuvant therapy for LAPC in approximately 260 patients in the second quarter of 2019
Expect to commence a randomized, double-blind, placebo-controlled Phase 3 clinical trial in IPF with a primary endpoint of change in forced vital capacity (FVC) from baseline in approximately 500 patients in the second quarter of 2019
Expect to complete the first year of treatment for all 21 non-ambulatory DMD patients in our Phase 2 trial in the first quarter of 2019
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Wednesday, February 27, 2019, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial (888) 771-4371 (U.S. and Canada) or (847) 585-4405 (international), reference the FibroGen fourth quarter and full year 2018 financial results conference call, and use passcode 48309188. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 48309188#.

About Roxadustat
Roxadustat (FG-4592), discovered by FibroGen, is a first-in-class, orally administered small molecule currently approved in China for the treatment of anemia in CKD patients on dialysis. Roxadustat is a HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, improving iron regulation, and overcoming the negative impact of inflammation on hemoglobin syntheses and red blood cell production by downregulating hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation and without a need for supplemental intravenous iron.

FibroGen and its collaboration partners are pursuing four approval pathways in major jurisdictions to prepare for commercialization worldwide:

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa.
AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.
About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, has been granted Orphan Drug Designation (ODD) in each of these indications. Pamrevlumab has also received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with IPF and for patients with locally advanced unresectable pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). Across all trials, pamrevlumab has consistently demonstrated a good safety and tolerability profile to date. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

Tocagen Reports Fourth Quarter and Full Year 2018 Financial and Business Results

On February 27, 2019 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported financial results and business highlights for the fourth quarter and full year ended December 31, 2018 (Press release, Tocagen, FEB 27, 2019, View Source [SID1234533808]).

"We had a very strong close to the year, accomplishing all of our 2018 business goals. In particular, NRG Oncology’s selection of Toca 511 & Toca FC for a Phase 2/3 trial in newly diagnosed glioblastoma was a major accomplishment for our team and we look forward to initiating this trial in late 2019. Expansion of our late-stage cancer-selective gene therapy program regimen into the front-line indication could pave the way to having a greater impact on more patients in the years ahead," said Marty Duvall, chief executive officer of Tocagen. "Furthermore, having ended the year with approximately $96 million in cash, we have a favorable financial position as we look towards the results in 2019 from our Phase 3 Toca 5 trial in recurrent high grade glioma and build for success going into 2020."

Fourth Quarter 2018 Highlights

NRG Oncology, a member of the National Cancer Institute’s National Clinical Trial Network, announced in November 2018 plans to conduct and sponsor a clinical trial to evaluate Toca 511 & Toca FC for the treatment of patients with newly diagnosed glioblastoma (GBM). The proposed NRG-BN006 Phase 2/3 trial will be the first clinical trial of the Toca 511 & Toca FC regimen in the newly diagnosed GBM setting, and is expected to commence in late 2019. NRG Oncology conducts practice-defining, multi-institutional trials funded primarily by the NCI.

Under Tocagen’s PRIME (PRIority MEdicines) designation for Toca 511 & Toca FC, the European Medicines Agency indicated that the statistical analyses, seamless design and use of overall survival as the primary endpoint in the ongoing Phase 3 Toca 5 clinical trial are appropriate for a potential marketing authorization applications for Toca 511 & Toca FC in Europe.

Tocagen presented clinical and preclinical data at congresses hosted by the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and Society for Neuro-Oncology (SNO). We identified immunologic biomarkers in our clinical trials that may help predict patient outcomes following treatment with Toca 511 & Toca FC, and preclinical studies demonstrated the additive benefits of combining Toca 511 & Toca FC with chemotherapy.

In December 2018, Tocagen raised $30.0 million of gross proceeds in an underwritten public offering of its common stock.

2019 Milestones

Toca 5 second interim analysis expected in the second quarter of 2019

Toca 5 final analysis planned for the fourth quarter of 2019

Prepare to initiate a rolling biologics license application (BLA) for Toca 511 & Toca FC in recurrent high grade glioma

Build U.S. commercial team for potential launch of Toca 511 & Toca FC

NRG Oncology to initiate NRG-BN006 clinical trial evaluating Toca 511 & Toca FC in newly diagnosed GBM in late 2019

Report updated Toca 6 safety and immune activity data in advanced solid tumors

Fourth Quarter 2018 Financial Results

Research and Development (R&D) Expenses: R&D expenses were $15.6 million for the quarter ended December 31, 2018, compared to $8.3 million for the quarter ended December 31, 2017. The R&D expenses in both periods were primarily driven by costs to support the Toca 5 trial and to support the manufacturing of drug product. The increase in 2018 reflects primarily higher manufacturing spend as compared to the same period in 2017.

General and Administrative (G&A) Expenses: G&A expenses were $3.5 million for the quarter ended December 31, 2018, compared to $2.4 million for the quarter ended December 31, 2017. The increase in G&A expenses was primarily due to higher costs to support increased operations activity.

Net Loss: Net loss was $19.6 million, or $0.96 per common share (basic and diluted), for the quarter ended December 31, 2018, compared to a net loss of $10.8 million, or $0.55 per common share (basic and diluted), for the quarter ended December 31, 2017. The 2018 calculation is based on 20.5 million average common shares outstanding for the fourth quarter of 2018, compared to 19.8 million average common shares outstanding for the fourth quarter of 2017.

2018 Twelve-Month Results

License Revenue: License revenue was $18.0 million for the 12 months ended December 31, 2018, compared to less than $0.1 million for the 12 months ended December 31, 2017. The 2018 revenue was associated with a $16.0 million upfront payment and a $2.0 million development milestone earned upon completion of enrollment in the Toca 5 clinical study, both recognized under Tocagen’s license agreement with ApolloBio.

R&D Expenses: R&D expenses were $51.1 million for the 12 months ended December 31, 2018, compared to $29.1 million for the 12 months ended December 31, 2017. The increase in R&D expenses primarily reflects increased costs in manufacturing and our Toca 5 clinical trial.

G&A Expenses: G&A expenses were $12.8 million for the 12 months ended December 31, 2018, compared to $8.6 million for the 12 months ended December 31, 2017, with the increase primarily driven by higher personnel costs and costs to support increased operations activity.

Net Loss: Net loss was $49.0 million, or $2.44 per common share (basic and diluted), for the 12 months ended December 31, 2018, compared to a net loss of $38.9 million, or $2.66 per common share (basic and diluted), for the 12 months ended December 31, 2017. The 2018 calculation is based on 20.1 million average common shares outstanding for the 12 months ended December 31, 2018, compared to 14.6 million average common shares outstanding for the prior year.

Cash Position and Guidance

Cash, cash equivalents and marketable securities were $96.1 million at December 31, 2018 compared to $88.7 million at December 31, 2017. Total gross cash burn to support operations was $51.3 million for the year ended December 31, 2018. Based on current operating plans, Tocagen estimates the total cash used in 2019 to fund operations and capital expenditures will be approximately $65 million.

About Toca 511 & Toca FC

Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511 (vocimagene amiretrorepvec), and an investigational small molecule, Toca FC (flucytosine, extended-release). Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.