On March 10, 2022 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, reported business updates, upcoming milestones and financial results for the fourth quarter and year ended December 31, 2021 (Press release, Geron, MAR 10, 2022, View Source [SID1234609887]). The Company ended 2021 with $212.7 million in cash and marketable securities, which the Company believes is sufficient to fund current operations through the end of the first quarter of 2023.

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"We made significant accomplishments in 2021 to advance the development of imetelstat toward two important Phase 3 data readouts, which if positive, have the potential to transform patient care in lower risk MDS and refractory MF," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "With completion of enrollment in IMerge Phase 3 last October, we look forward to top-line results from that trial in early January 2023. If those results confirm similar safety, as well as the depth, breadth and durability of transfusion independence that was observed in our Phase 2 trial, then upon approval of an NDA, we expect our U.S. commercial launch of imetelstat in lower risk MDS to occur as early as the first half of 2024."

Dr. Scarlett added, "In 2021, we also made progress with the IMpactMF Phase 3 trial in refractory MF, by opening 50% of the planned clinical sites to patient enrollment. In 2022, we plan to open the rest of the selected clinical sites to enable the planned interim analysis in 2024."

Dr. Scarlett also noted, "Building on the strong evidence of imetelstat’s disease modification potential from our Phase 2 trials, we started several new programs in 2021. We believe that the data to be generated from these programs over the next few years will provide strategic value to the imetelstat franchise through the potential expansion into new myeloid and lymphoid hematologic indications, as well as into combination regimens."

Key Upcoming Milestones Expected

Top-line results from IMerge Phase 3 in early January 2023
Open the rest of the selected clinical sites in IMpactMF for enrollment to enable the planned interim analysis in 2024
Expand into additional indications and treatment combinations:
Start of IMproveMF Phase 1 study of imetelstat + ruxolitinib in frontline MF in 1H 2022
Start of IMpress Phase 2 study of single-agent imetelstat in R/R AML and HR MDS in 2H 2022
Start of TELOMERE Phase 1/2 study of imetelstat + HMAs or venetoclax in R/R AML in 2H 2022
Top-Line Results Expected in Early January 2023 from IMerge Phase 3 in Lower Risk Myelodysplastic Syndromes (MDS)

Assuming the results of IMerge Phase 3 support regulatory submissions, Geron plans to submit a New Drug Application (NDA) in the United States in the first half of 2023 and a Marketing Authorization Application (MAA) in Europe in the second half of 2023 for imetelstat in lower risk MDS. Upon potential approval by the United States Food and Drug Administration (FDA) of the NDA, the Company expects that its commercial launch of imetelstat in lower risk MDS in the United States could occur as early as the first half of 2024.

Planned Interim Analysis in 2024 from IMpactMF in Refractory Myelofibrosis (MF)

IMpactMF, the only Phase 3 clinical trial in MF with overall survival (OS) as a primary endpoint, is planned to engage approximately 180 clinical sites across North America, South America, Europe, Australia and Asia to facilitate patient recruitment and enrollment into the trial. The Company expects to open for enrollment the remaining approximately 50% of selected clinical sites in 2022.

Under current planning assumptions around enrollment and median overall survival for each treatment arm, the Company expects to conduct the interim analysis in 2024 and the final analysis in 2025. The final analysis for OS is planned to be conducted after more than 50% of the patients enrolled in the trial have died. An interim analysis of OS is planned to be conducted after approximately 70% of the total projected number of events for the final analysis have occurred. If the pre-specified, statistically significant difference in OS between the two treatment arms is met at the interim analysis, it is possible that data from the interim analysis could support a registration filing. Both the planned interim and final analyses are event-driven and could occur on different timelines than currently expected.

Pipeline Expansion to Enhance Imetelstat Potential

In November 2021, the Company unveiled three new clinical programs and one preclinical program for imetelstat. These programs explore the use of imetelstat as a single agent and in combination with current standard of care therapies to expand the potential application of imetelstat.

In the first half of 2022, Geron plans to initiate IMproveMF, a company-sponsored Phase 1 study of imetelstat in combination with ruxolitinib in frontline MF patients. In addition, in collaboration with key opinion leaders with expertise in acute myeloid leukemia (AML), the Company is supporting investigator-led studies in relapsed/refractory AML and higher risk MDS (HR MDS) to evaluate imetelstat as a single agent and in combination with venetoclax or hypomethylating agents (HMAs). These studies are expected to start in the second half of 2022. The preclinical program in lymphoid malignancies is being conducted at MD Anderson Cancer Center, and the Company expects preliminary results from ongoing in vitro and in vivo experiments to be available by the end of 2022.

Fourth Quarter and Full Year 2021 Results

For the fourth quarter of 2021, the Company reported a net loss of $32.0 million, or $0.10 per share, compared to $23.8 million, or $0.07 per share, for the fourth quarter of 2020. Net loss for the full year of 2021 was $116.1 million, or $0.35 per share, compared to $75.6 million, or $0.28 per share, for the full year of 2020.

Revenues for the three and twelve months ended December 31, 2021 were $1.0 million and $1.4 million, respectively, compared to $50,000 and $253,000 for the same periods in 2020. Revenues in 2021 and 2020 primarily reflect estimated royalties from sales of cell-based research products from the Company’s divested stem cell assets. In connection with the 2013 divestiture of Geron’s human embryonic stem cell assets, including intellectual property and proprietary technology, to Lineage Cell Therapeutics, Inc. (formerly BioTime, Inc., which acquired Asterias Biotherapeutics, Inc.), Geron is entitled to receive royalties on sales from certain research or commercial products utilizing Geron’s former intellectual property. The increase in revenues in 2021 compared to 2020 primary reflects retroactive royalties of approximately $911,000 on product sales of cell-based research products.

Total operating expenses for the three and twelve months ended December 31, 2021 were $32.0 million and $115.4 million, respectively, compared to $23.3 million and $77.2 million for the same periods in 2020.

Research and development expenses for the three and twelve months ended December 31, 2021 were $24.2 million and $85.7 million, respectively, compared to $16.2 million and $51.5 million for the same periods in 2020. The increase in research and development expenses for the three and twelve months ended December 31, 2021, compared to the same periods in 2020, primarily reflects increased clinical development costs associated with conducting two Phase 3 clinical trials, higher imetelstat manufacturing costs for producing validation batches at contract manufacturers to enable future production of imetelstat for clinical and commercial purposes and higher personnel-related costs for additional headcount.

General and administrative expenses for the three and twelve months ended December 31, 2021 were $7.9 million and $29.7 million, respectively, compared to $7.1 million and $25.7 million, for the same periods in 2020. The increase in general and administrative expenses for the three and twelve months ended December 31, 2021, compared to the same periods in 2020, primarily reflects new costs in connection with pre-commercial activities, including modernizing the internal infrastructure to support a commercial launch, and higher legal costs.

Interest income for the three and twelve months ended December 31, 2021 was $106,000 and $527,000, respectively, compared to $243,000 and $1.8 million for the same periods in 2020. The decrease in interest income for the three and twelve months ended December 31, 2021, compared to the same periods in 2020, primarily reflects lower yields on the Company’s marketable securities portfolio.

Interest expense for the three and twelve months ended December 31, 2021 was $1.1 million and $3.7 million, respectively, compared to $754,000 and $760,000 for the same periods in 2020. In September 2020, the Company secured a new debt facility for up to $75 million. As of December 31, 2021, a total of $50 million has been drawn down under the facility.

Financial Resources and Projected 2022 Financial Guidance

The Company ended 2021 with $212.7 million in cash and marketable securities, which the Company believes is sufficient to fund current operations through the end of the first quarter of 2023.

For fiscal year 2022, under generally accepted accounting principles (GAAP), the Company expects total operating expenses in the range of approximately $155 million to $165 million, which includes non-cash items such as: stock-based compensation expense, amortization of debt discounts and issuance costs and depreciation and amortization. The Company expects non-GAAP total operating expenses for fiscal year 2022, which excludes estimated non-cash items such as: stock-based compensation expense, amortization of debt discounts and issuance costs and depreciation and amortization, in the range of approximately $140 million to $150 million.

The fiscal year 2022 financial guidance reflects costs to support preparatory activities for top-line results in lower risk MDS; NDA and commercial readiness; two ongoing Phase 3 clinical trials and new clinical studies expanding the pipeline; finalizing validation batches of imetelstat at contract manufacturers to enable future production of imetelstat for clinical and commercial purposes; projected increases in headcount and interest payments on outstanding debt.

As of December 31, 2021, the Company had 72 employees. The Company plans to grow to a total of approximately 90 to 100 employees by year-end 2022.

Conference Call

Geron will host a conference call at 4:30 p.m. ET on Thursday, March 10, 2022 to discuss business updates, expected upcoming milestones and fourth quarter and full year 2021 financial results.

A live webcast of the conference call and related presentation will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the webcast by registering online using the following link, View Source Participants that are unable to register online can access the conference call via telephone by dialing domestically +1 (888) 330-2434 or internationally +1 (240) 789-2725. The conference ID is 67335.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment.

About IMerge Phase 3

IMerge Phase 3 is a double-blind, randomized, placebo-controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 170 transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS), also referred to as lower risk MDS, who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint is the rate of red blood cell (RBC) transfusion independence (TI) for any consecutive period of eight weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks, or 24-week RBC-TI rate, duration of TI and the rate of hematologic improvement-erythroid (HI-E), defined as a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden.

IMerge Phase 3 is fully enrolled and patient enrollment has been closed. For additional information about IMerge Phase 3, visit ClinicalTrials.gov/NCT02598661.

About IMpactMF

IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis (MF) who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete remission, partial remission, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.

IMpactMF is currently enrolling patients. For further information about IMpactMF, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT04576156.

On March 10, 2022 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported its financial results for the fourth quarter and full year 2021 and provided an overview of recent business highlights (Press release, Aligos Therapeutics, MAR 10, 2022, View Source [SID1234609886]).

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"Last year was very productive for our team," said Lawrence Blatt, PhD, MBA, Chairman & CEO of Aligos. "We made great strides in advancing our CHB, NASH and COVID portfolios, which has resulted in 3 drug candidates currently being evaluated in their target patient populations and our 4th drug candidate (CHB siRNA) on track to begin dosing in the clinic in the second half of this year. As a result, we expect multiple important data readouts to occur throughout 2022, including safety and proof of concept data for our CAM, ASO and THR-β drug candidates. These data have the potential to be important drivers of shareholder value and we look forward to sharing them as they emerge."

"In 2021, we received important validation of our expertise in developing oligonucleotide drug candidates when Merck entered into a second NASH research collaboration with Aligos," added Leo Beigelman, PhD, President of Aligos. "We view oligonucleotide approaches as powerful tools for silencing mRNA transcripts in a highly specific and durable manner. These approaches are well adapted to silencing transcripts important in driving the pathogenesis seen in CHB and NASH."

Recent Business Highlights

Aligos Portfolio of Drug Candidates:

Capsid Assembly Modulator (CAM)(ALG-000184)
After demonstrating an acceptable safety and PK profile and similar, robust DNA and RNA suppressive effects in HBeAg-negative subjects at the 50 and 100 mg dose levels and in HBeAg-positive subjects at the 100 mg dose level in 2021, further dose exploration has been initiated for our CAM (ALG-000184). Currently, the 10 mg dose level is being evaluated in HBeAg-negative subjects to better define the dose-response characteristics of ALG-000184. Additionally, based on the marked, best-in-class reductions seen in HBV DNA and RNA levels, we are currently exploring the potential of 300 mg ALG-000184 to reduce HBsAg levels (via the "secondary mechanism of action" of CAMs) in HBeAg-positive subjects. We plan to conduct longer term studies (12 weeks) later this year and share these data at a scientific conference in H2 2022.

Antisense Oligonucleotide (ASO)(ALG-02572)
Recently, our Phase 1a evaluation of single ascending doses (SAD) of subcutaneously administered ALG-020572 in healthy volunteers (HVs) was completed and we initiated the Phase 1b portion of the study (in subjects with chronic hepatitis B (CHB)). Enrollment in the first CHB cohort is now complete. Over this year, we plan to evaluate multiple CHB cohorts at varying dose levels to define the dose-response characteristics and risk-benefit profile of ALG-020572. Safety and antiviral activity data are planned to be shared at a scientific conference in H2 2022.

Small Interfering RNA (siRNA)(ALG-125755)
Phase 1 enabling nonclinical studies for our siRNA (ALG-125755) were initiated in 2021 and remain on track for completion in H1 2022. If positive, we expect these data to enable dosing in a planned Phase 1a/1b study starting in HVs in H2 2022. Dosing in CHB subjects is anticipated to begin in H1 2023. HV data are planned to be shared at a scientific conference in H2 2022.

Thyroid Hormone Receptor – Beta (THR-B)(ALG-055009)
Phase 1 enabling nonclinical studies for our THR-β drug candidate (ALG-055009) were completed in 2021, which enabled initiation of a SAD study in HVs in Q4 2021. Administration of single doses in HVs and multiple doses in subjects with hyperlipidemia is ongoing. Topline data, including safety, PK, and pharmacodynamic (lipid) data, are expected in Q3 2022. We also plan to share these data at a scientific conference in H2 2022.

SARS-CoV-2 3CL Protease Inhibitor (COVID-PI)
Multiple COVID-PIs which are more potent in vitro than nirmatrelvir and do not require ritonavir boosting have been identified. These drug candidates are in late lead optimization and we expect to nominate a clinical candidate in the near future. Phase 1 enabling nonclinical studies of this compound are planned to initiate in Q3 2022.

Merck Collaboration
Significant progress has been made in the nonalcoholic steatohepatitis (NASH) oligonucleotide research collaboration with Merck with respect to an initial undisclosed target, utilizing Aligos’ know-how and our proprietary oligonucleotide chemistry platform. In addition to advancing this program further into lead optimization, the achievements of this collaboration also resulted in Merck committing to an oligonucleotide research collaboration for a second undisclosed NASH target.

PD-L1 Small Molecule Inhibitors
We are also developing orally delivered, liver-targeted small molecule PD-L1 inhibitors in order to modulate host immune responses to hepatitis B virus (HBV). This approach has demonstrated favorable effects on HBsAg lowering in patients with CHB. A lead compound, ALG-093453, has been shown to induce T cell activation in an in vitro Jurkat T cell-NFAT assay with similar activity to the PD-1 monoclonal antibody (mAb), nivolumab. In addition, ALG-093453 induces HBV-antigen specific IFN-γ secretion from T cells from patients infected with HBV to a similar extent to nivolumab and the PD-L1 mAb, durvalumab.

Corporate:

NASH Related License & Collaboration Agreement
Aligos Expands Collaboration with Merck to Develop Oligonucleotide Therapies for NASH (Q1’22)

Under the original agreement, Merck and Aligos committed to applying Aligos’ oligonucleotide platform technology to discover, research, optimize and develop oligonucleotides directed against a certain undisclosed NASH target. That agreement has now been expanded to include the granting of a license to Merck of an early-stage program with respect to a second undisclosed NASH target on which Aligos has previously been working independently and separately from Merck. In addition, under this expanded arrangement, Merck has the ability to add to the collaboration a third target of interest with respect to the cardiometabolic/fibrosis space.
Financial Results for the Fourth Quarter and Full Year 2021

Cash, cash equivalents and investments totaled $205.8 million on December 31, 2021, compared with $243.5 million on December 31, 2020. With the discontinuation of the development of our STOPS drug candidate, ALG-010133, that was being explored to address CHB, together with the proceeds resulting from our partnering activities and other cost saving measures, we believe our December 31, 2021 cash balance provides sufficient cash to fund planned operations into the first half of 2024.

Net losses for the three months ended December 31, 2021 were $37.7 million or basic and diluted net loss per common share of $(0.89) compared to $34.4 million or basic and diluted net loss per common share of $(1.09) for the three months ended December 31, 2020. For the year ended December 31, 2021, Net losses were $128.3 million or basic and diluted net loss per common share of $(3.22) compared to $108.5 million or basic and diluted net loss per common share of $(10.87) for the year ended December 31, 2020.

Research and development (R&D) expenses for the three months ended December 31, 2021 were $28.6 million, compared with $28.1 million for the same period of 2020. The increase in R&D expenses for this comparative period is primarily related to increases in salaries and employee-related expenses. Total R&D stock-based compensation expense incurred for the three months ended December 31, 2021, was $1.9 million compared with $0.7 million for the same period for 2020. R&D expenses for the year ended December 31, 2021 were $104.2 million, compared with $79.9 million for the same period of 2020. The increase in R&D expenses for this comparative period is primarily attributable to increased expenses related to the Company’s continued development and manufacturing of ALG-000184, ALG-020572 clinical trial activities and remaining clinical and manufacturing expenses related to the discontinuation of ALG-010133 clinical program, as well as increases in salaries and employee-related expenses and preclinical programs. Total R&D stock-based compensation expense incurred in the year ended December 31, 2021, was $7.6 million, compared with $1.0 million for the same period of 2020.

General and administrative expenses for the three months ended December 31, 2021 were $9.7 million, compared to $6.2 million for the same periods of 2020 and for the year ended December 31, 2021 were $28.5 million, compared to $17.9 million for the same period of 2020. The increase in G&A expenses for both comparable periods is primarily attributable to higher employee-related costs associated with the growth of the Company’s operations and additional professional, legal and consulting services related to being a public company. Total G&A stock-based compensation expense incurred for the three months ended December 31, 2021 was $1.7 million compared with $0.6 million for the same period for 2020 and for the year ended December 31, 2021 was $5.9 million, compared with $1.9 million for the same period of 2020.

On March 10, 2022 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported financial and operating results for the fourth quarter and full year 2021 (Press release, Lineage Cell Therapeutics, MAR 10, 2022, View Source [SID1234609885]). Lineage management will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its fourth quarter and full year 2021 financial and operating results and to provide a business update.

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"2021 was a transformative year for Lineage, in part because we entered into a worldwide corporate partnership with Roche and Genentech for our OpRegen program for the treatment of ocular disorders," stated Brian M. Culley, Lineage CEO. "We have continued to execute on our strategic plan to position Lineage as a leader in the allogeneic cell transplant revolution, supported by our regenerative medicine technology; manufacturing and differentiation of specific cell types. These cells are transplanted into the body to restore or improve function lost due to aging, injury, or disease. We believe the collaboration of our lead asset with a world-class pharmaceutical partner with extensive ophthalmology capabilities brings significant validation to our technology platform and our approach to product development. As importantly, this transaction adds significant new capital to help support the advancement of our OPC1 program, VAC platform, and the expansion of our regenerative medicine pipeline into new disease settings. Our corporate objectives in 2022 will be focused on the continued advancement of our current clinical programs and making responsible investments in the expansion of our novel approach to cell transplant medicine in disease settings where we believe we can make a meaningful impact. We look forward to announcing our new, internally developed pipeline candidate later this quarter."

Some of the more significant milestones we achieved in 2021 include:

– Established an exclusive worldwide collaboration and license agreement with Roche and Genentech (the "Roche Collaboration"), for the development and commercialization of OpRegen, a retinal pigment epithelium ("RPE") cell therapy, for the treatment of ocular disorders, including advanced dry age-related macular degeneration ("dry AMD") with geographic atrophy ("GA"), in a transaction worth up to $670 million in addition to double digit royalties;

– Reported a fourth case of retinal restoration with OpRegen; notably, four patients with dry AMD were observed to have areas of GA which diminished or remained unchanged relative to baseline for a period of at least 12 months;

– Announced a worldwide license agreement with Immunomic Therapeutics, Inc. for an allogeneic cell-based cancer immunotherapy based on our VAC platform; Lineage received $2 million upfront and may receive up to $67 million in development and commercial milestones plus royalties;

– Entered into an exclusive agreement with Neurgain Technologies to evaluate a novel delivery system for OPC1 to treat Spinal Cord Injury;

– Expanded our management team with the additions of Chief Financial Officer, Kevin L. Cook, as well as General Counsel, George A. Samuel, III; and

– Expanded our Board of Directors with the appointments of Drs. Anula Jayasuriya, M.D., Ph.D., M.B.A. and Dipti Amin, MBBS, FFPM, MRCGP, DCPSA, DCH, DRCOG, DGM.

Some of the events and milestones anticipated by Lineage in 2022 include:

– Announcement of a new pipeline program from our regenerative medicine cell therapy platform anticipated in March;

– Completion of GMP production of OPC1 via an improved and larger-scale manufacturing process and a new thaw-and-inject formulation; anticipated in Q1 2022;

– FDA interaction to discuss recent manufacturing improvements made to OPC1, anticipated in Q3 2022;

– Initiation of clinical performance and safety testing of the novel Parenchymal Spinal Delivery system device for OPC1, with an anticipated Investigational New Drug ("IND") amendment submission in Q3 2022;

– Updates from the ongoing VAC2 Phase 1 non-small cell lung cancer study; anticipated in Q2 2022;

– An anticipated IND submission for VAC2 in 2H 2022;

– Continued development of a cell-based therapeutic for glioblastoma with our strategic partner, Immunomic Therapeutics; ongoing throughout 2022;

– Evaluation of opportunities for new VAC product candidates based on internally identified or partnered tumor antigens; ongoing throughout 2022;

– Evaluation of partnership opportunities and expansion of existing collaborations; ongoing throughout 2022; and

– Continued participation in numerous investor and partnering meetings and medical and industry conferences to broaden the knowledge of our work.

Balance Sheet Highlights

Cash and cash equivalents totaled $55.7 million as of December 31, 2021. In January 2022, we received a $50.0 million upfront payment related to the Roche Collaboration and made subsequent payments pursuant to Lineage’s downstream obligations.

Fourth Quarter Operating Results

Revenues: Lineage’s revenue is generated primarily from research grants, royalties, and licensing fees. Total revenues for the three months ended December 31, 2021 were approximately $1.2 million, an increase of $0.8 million as compared to $0.4 million for the same period in 2020. The increase was related to royalties and licensing fees, which was primarily driven by licensing revenues in connection with collaboration agreements entered into in 2021.

Operating Expenses: Operating expenses are comprised of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Total operating expenses for the three months ended December 31, 2021 were $29.2 million, an increase of $23.1 million as compared to $6.1 million for the same period in 2020. The overall increase was substantially driven by $20.6 million in higher OpRegen-related expenses, mainly due to accruals for future financial obligations payable to the Israel Innovation Authority ("IIA") and Hadasit Medical Research Services and Development Ltd ("Hadasit"), related to the receipt of the $50.0 million upfront payment under the Roche Collaboration.

R&D Expenses: R&D expenses for the three months ended December 31, 2021 were $24.8 million, an increase of $22.2 million as compared to $2.6 million for the same period in 2020. The increase was substantially driven by the $21.0 million accrual for future financial obligations payable to IIA and Hadasit. Other drivers of the increased variance were related to $1.0 million and $0.6 million in higher expenses to support the development of the OPC1 and VAC programs, respectively.

G&A Expenses: G&A expenses for the three months ended December 31, 2021 were $4.4 million, an increase of $0.9 million as compared to $3.5 million for the same period in 2020. The increase was primarily attributable to increases of $0.3 million in legal and litigation expenses, $0.3 million in salaries and related benefits, and $0.3 million in share-based compensation expense.

Loss from Operations: Loss from operations for the three months ended December 31, 2021 was $28.2 million, an increase of $22.3 million as compared to $5.9 million for the same period in 2020, principally owing to collaboration-related expense accruals of $21.0 million which were not deferrable expenses, and as such, do not align with current period revenues due to revenue deferral accounting standards.

Other Income, Net: Other income, net for the three months ended December 31, 2021 was $0.2 million, compared to other income, net of $6.9 million for the same period in 2020. The variance was primarily related to changes in the value of marketable equity securities for the applicable periods.

Net Income/(Loss) Attributable to Lineage: The net loss attributable to Lineage for the three months ended December 31, 2021 was ($29.0) million, or ($0.17) per share (basic and diluted), compared to a net income attributable to Lineage of $2.0 million, or $0.01 per share (basic and diluted), for the same period in 2020. The large year-over-year change was principally due to the collaboration-related expense accruals amounting to ($0.12) per share which were not deferrable expenses, and as such, do not align with current period revenues due to revenue deferral accounting standards.

Full Year Operating Results

Revenues: Lineage’s revenue is generated primarily from research grants, royalties, and licensing fees. Total revenues for the year ended December 31, 2021 were $4.3 million, an increase of $2.5 million as compared to $1.8 million for the same period in 2020. The increase was primarily related to a $2.0 million increase in royalty revenues, and a $1.1 million increase in licensing revenues in connection with collaboration agreements, partially offset by a $0.6 million decrease in grant revenues.

Operating Expenses: Operating expenses are comprised of R&D expenses and G&A expenses. Total operating expenses for the year ended December 31, 2021 were $52.1 million, an increase of $24.2 million as compared to $27.9 million for the same period in 2020. The overall increase was substantially driven by $19.9 million in higher OpRegen-related expenses, mainly due to accruals for future financial obligations payable to IIA and Hadasit, related to the receipt of the $50.0 million upfront payment under the Roche Collaboration.

R&D Expenses: R&D expenses for the year ended December 31, 2021 were $33.9 million, an increase of $21.6 million as compared to $12.3 million for the same period in 2020. The increase was substantially driven by the $21.0 million accrual for future financial obligations payable to the IIA and Hadasit. Other drivers of the net increase variance were $2.2 million in higher manufacturing and device development costs to support the OPC1 program, offset by $0.3 million in lower VAC program expenses.

G&A Expenses: G&A expenses for the year ended December 31, 2021 were $18.2 million, an increase of approximately $2.6 million as compared to $15.6 million for the same period in 2020. The increase was primarily related to increases of $1.3 million in legal, litigation and patent expenses, $0.9 million in share-based compensation expenses, and $0.3 million in payroll and related benefits expense.

Loss from Operations: Loss from operations for the year ended December 31, 2021 was $49.2 million, an increase of $22.8 million as compared to $26.4 million for the same period in 2020, principally owing to collaboration-related expense accruals of $21.0 million which were not deferrable expenses, and as such, do not align with current period revenues due to revenue deferral accounting standards.

Other Income, Net: Other income, net for the year ended December 31, 2021 was $5.9 million, compared to other income, net of $4.5 million for the same period in 2020. The net variance was primarily related to the changes in the value of marketable equity securities for the applicable periods.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the year ended December 31, 2021 was $43.0 million, or $0.26 per share (basic and diluted), compared to a net loss attributable to Lineage of $20.6 million, or $0.14 per share (basic and diluted), for 2020. The large year-over-year change is principally due to collaboration-related expense accruals amounting to $0.13 per share which were not deferrable expenses, and as such, do not align with current period revenues due to revenue deferral accounting standards.

Conference Call and Webcast

Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through March 18, 2022, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 7718167.

On March 10, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported financial results and operational highlights for the fourth quarter and fiscal year ended December 31, 2021 (Press release, Lantern Pharma, MAR 10, 2022, View Source/news/press-releases/detail/82/lantern-pharma-reports-fourth-quarter-and-fiscal-year-2021" target="_blank" title="View Source/news/press-releases/detail/82/lantern-pharma-reports-fourth-quarter-and-fiscal-year-2021" rel="nofollow">View Source [SID1234609884]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"2021 was a transformational year for Lantern Pharma as we strengthened our financial position, significantly expanded our A.I. platform, and achieved multiple key clinical milestones that further advanced our oncology portfolio," stated Panna Sharma, President and CEO of Lantern Pharma. "Our proprietary RADR A.I. platform surpassed 18 billion data points and grew over 1,000% in 2021, significantly exceeding our growth expectations. This further development of RADR is enabling an acceleration of the insights that are powering development decisions for our drug candidates and also support evaluation of drugs and drug candidates of other biopharma companies."

"Across our entire portfolio of late-stage drug programs, we are progressing towards launching Phase 1 and Phase 2 clinical trials in 2022, including the Phase 2 trial for LP-300, The Harmonicä Clinical Trial, for advanced non-small cell lung cancer in never smokers. Our dedicated team is focused on completing the requirements and details to launch these trials including IND-enabling studies and submissions, clinical site selection, and patient enrollment," stated Sharma.

Operational Highlights:

RADR Platform Growth and Development

Surpassed 18 billion data points for RADR platform, a significant growth of more than 1,000% from year-end 2020; forecasting to reach more than 25 billion data points by year-end 2022.
The ongoing growth of RADR data points is expected to drive continual improvement in Lantern’s ability to rapidly identify new indications, combination therapies, and mechanisms of action for the Company’s drug candidates.
Expanding RADR’s capabilities with a focus on increasing the number of machine learning algorithms and self-learning algorithms.
The Company expects to continue to expand its focus on building biopharma collaborations to utilize and expand on the growth of RADR.
Lantern’s Portfolio of Targeted Therapies
Lantern Pharma is currently developing four drug candidates and an Antibody-Drug Conjugate (ADC) program across eight disclosed tumor targets, and several undisclosed targets. Lantern’s portfolio currently includes:

LP-100 – is in a Phase 2 trial for the treatment of metastatic castration resistant prostate cancer (mCRPC). We are evaluating possibilities for further enrollment in the current Phase II trial as well as other potential clinical development opportunities. Lantern reacquired global rights to LP-100 in July 2021.
LP-300 – is preparing to enter a Phase 2 clinical trial, the Harmonicä Clinical Trial, during 2022. The Harmonicä trial will be a 90 patient, two-arm, open label clinical trial focused on never smoker patients with relapsed primary adenocarcinoma of the lung, a type of NSCLC.
LP-184 – is in preparation for potentially multiple Phase 1 clinical trial launches for genomically defined cancers, including pancreatic, glioblastoma multiforme (GBM), bladder and atypical teratoid rhabdoid tumors (ATRT).
The FDA granted LP-184 Orphan Drug Designations for the treatment of pancreatic cancer, GBM, and ATRT and a Rare Pediatric Disease Designation for treatment of ATRT. These designations will assist the advancement of LP-184 towards clinical studies. Under the Rare Pediatric Disease Priority Review Voucher Program companies may be eligible to receive a priority review voucher if the product satisfies certain conditions, including receipt of regulatory marketing approval following required clinical testing. Vouchers may be sold or transferred to another sponsor, and past transfers of vouchers have occurred at average prices of more than $100 million.

LP-284 – is in preclinical development and has demonstrated potency at low nanomolar levels in hematological cancer cell lines, including lymphoma, multiple myeloma, and leukemia. LP-284’s indications in hematological cancers are distinct from the indications targeted by LP-184 and were generated with the assistance of RADR insights.
Antibody Drug Conjugate (ADC) Program – we have selected and ranked multiple targeting antibodies of interest with potential to be linked to selected cytotoxic payloads. We are currently evaluating various cytotoxic agents and classes of agents to be used as ADC payloads.
World-Class Scientific Collaborations

Expanded collaboration with the National Cancer Institute to accelerate the path to first in-human clinical trials for drug candidates LP-184 and LP-284.
Entered collaboration with The Greehey Children’s Cancer Research Institute (GCCRI) at University of Texas Health Science Center-San Antonio to expand Lantern’s drug portfolio research into several additional pediatric cancers.
Continued GBM & brain cancer collaboration with Johns Hopkins & Kennedy Krieger Institute to develop Phase 1 clinical design and further validate LP-184’s ability to works independently of MGMT (a DNA repair enzyme) status.
Expanded collaboration with Fox Chase Cancer Center in pancreatic cancers with a focus on clinical design and strategy for LP-184.
Launched a research collaboration with The Danish Cancer Society Research Center to support development of drug candidates LP-100 and LP-184 in 9 solid tumor types that have a known deficiency in DNA repair mechanisms. LP-100 and LP-184 have both been shown to have a synthetically lethal impact on tumors deficient in DNA repair mechanisms.
Publications and Presentations

Published two scientific articles in Oncotarget and BMC Bioinformatics highlighting the effectiveness of Lantern’s drug candidate LP-184 in potential tumor indications.
Presented positive preclinical data on the efficacy of LP-284 in hematologic cancers at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
Preclinical data supporting the effectiveness of LP-184 in select pancreatic cancers was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Special Conference.
The effectiveness of LP-184 in multiple in vitro and in vivo Glioblastoma models was presented at the Society for Neuro-Oncology (SNO) 2021 Annual Meeting.
On World Pancreatic Cancer Day, Lantern hosted a virtual KOL webinar on the potential of drug candidate LP-184 for pancreatic cancer.
Additional Highlights

Strengthened intellectual property estate with 12 new patent applications, with the current total IP estate at over 80 active patents and patent applications across 14 patent families.
Completed strategic hires to expand and strengthen Lantern’s data science, research, management, and communications teams.
Financial Highlights:

Raised gross proceeds of $69 million USD through January 2021 public offering and full exercise of underwriter’s over-allotment option.
Capital raised extends cash runway into 2025, allowing the Company to focus on efficiently developing its portfolio of promising oncology therapeutics.
Authorized a share repurchase program to acquire up to $7 million of the Company’s common stock. Repurchases of shares of common stock pursuant to the repurchase program amounted to $0.9 million during the quarter and year ended December 31, 2021 and an additional $2.2 million of repurchases from January 1, 2022 through March 1, 2022.
Fourth Quarter and 2021 Financial Overview:

Balance Sheet: Cash, cash equivalents, and marketable securities were $70.7 million as of December 31, 2021, compared to $19.2 million as of December 31, 2020. The quarterly and annual cash burn for 2021 reflects our capital-efficient, collaborator-centered business model.
R&D Expenses: Research and development expenses were $2.2 million and $7.6 million for the quarter and year ended December 31, 2021 compared to $1.4 million and $2.2 million for the quarter and year ended December 31, 2020, respectively. The annual increase was primarily attributable to increases in product candidate manufacturing related expenses of approximately $2.7 million, increases in research studies of approximately $0.8 million, increases in research and development payroll expenses of approximately $0.7 million, and an increase of $1.0 million related to the upfront payment to Allarity Therapeutics under the Allarity Asset Purchase Agreement, which was a nonrecurring expense.
G&A Expenses: General and administrative expenses were $1.4 million and $5.0 million for the quarter and year ended December 31, 2021 compared to $1.6 million and $3.7 million for the quarter and year ended December 31, 2020, respectively. The annual increase was primarily attributable to increases in business and corporate development expense of approximately $0.4 million, increases in corporate insurance expense of approximately $0.6 million, and increases in legal and patent related expenses of approximately $0.4 million.
Net Loss: Net losses were $3.5 million (or $0.31 per share) and $12.4 million (or $1.13 per share) for the quarter and year ended December 31, 2021, compared to a net loss of $2.9 million (or $0.47 per share) and $5.9 million (or $1.37 per share) for the quarter and year ended December 31, 2020, respectively.
2022 Key Objectives:

Launch of The Harmonicä Trial – Ph. 2 clinical trial for LP-300 in NSCLC
Advance LP-100 clinical trial
Launch Ph. 1 clinical trial for LP-184 in solid tumors
Launch Ph. 1/2 clinical trial for LP-184 in GBM
Progress LP-184 in ATRT towards Ph. 1/2 clinical trial
Advance pediatric cancer program
Advance ADC preclinical studies to support future Phase 1 launch
Explore potential combinations for LP-184 & LP-300 with other existing approved drugs
Strategically grow RADR A.I. platform to 25 billion datapoints
Licensing and partnership opportunities
2022 Outlook:
"During 2022 we expect to reach over 25 billion data points and also grow the methods and algorithms powering the analysis and insights of our RADR platform. Our team has been developing machine learning modules and algorithms that enable a wide range of analysis, correlations and predictions that are central to cancer drug development," added Sharma. "These additions to our platform are cornerstone to the advancement of our programs, and we believe this will be clearly demonstrated this year as we launch multiple clinical trials, report new data, and expand our collaborations."

"Our team will continue to advance our portfolio and our platform along with the development of new drug programs which we will be able to accomplish through our significant cash position, our focused strategy of collaborations and our data-driven drug development model. We are looking forward to a year of significant value creation for cancer patients and investors alike as we transform and accelerate the drug development process in oncology."

Earnings Call and Webinar Details
Lantern will host its fourth quarter and fiscal year 2021 earnings call and webinar today, Thursday, March 10 at 4:30 p.m. ET.

View Source
Related presentation materials will be accessible at: View Source
Replay Details

A replay of the 2021 earnings call and webinar will be available at View Source
(Press release, Lantern Pharma, MAR 10, 2022, View Source/news/press-releases/detail/82/lantern-pharma-reports-fourth-quarter-and-fiscal-year-2021" target="_blank" title="View Source/news/press-releases/detail/82/lantern-pharma-reports-fourth-quarter-and-fiscal-year-2021" rel="nofollow">View Source [SID1234609884])

On March 10, 2022 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer and infectious disease immunotherapies, reported financial results for the fourth quarter and full year ended December 31, 2021 and provided recent clinical and corporate updates (Press release, Gritstone Oncology, MAR 10, 2022, View Source [SID1234609883]).

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"2021 was a transformational year for Gritstone, as we extended our unique understanding of T cell antigens and proprietary vaccine delivery platforms to infectious disease, expanding our pipeline to include novel programs in COVID-19 (CORAL) and human immunodeficiency virus (HIV). Furthermore, we made significant progress with our tumor-specific neoantigen oncology programs, GRANITE and SLATE, which are advancing into later-stage trials," said Andrew Allen, M.D., Ph.D., Co-Founder, President and Chief Executive Officer of Gritstone. "In CORAL, we have demonstrated the potential for our T cell enhanced samRNA vaccine candidates to drive broad and durable immune responses in humans against both current and future variants against COVID-19, a credible first step toward developing a pan-coronavirus vaccine given the high conservation of many T cell antigens across different coronaviruses. Within oncology, we have continued to demonstrate the ability to drive a large and sustained T cell response, including the challenging CD8+ killer T cells, against tumor-specific neoantigens. These T cell responses are potentially driving the molecular and radiological responses observed in our "off the shelf" program, SLATE, which is focused on KRAS mutations, and also appear to be driving molecular response and extended overall survival in the end-stage colorectal cancer patients treated in our individualized program, GRANITE."

"Our collective experience with cancer immunotherapy suggests that as these programs move into earlier stages of disease, immune responses may be stronger and the potential benefits of our approach will be further accentuated," Dr. Allen continued. "Consequently, we are excited to have initiated randomized Phase 2/3 trials with GRANITE in colorectal cancer (CRC) patients where unmet need persists and checkpoint inhibitor therapy has had little impact to date in the vast majority of patients. We believe Gritstone is well-positioned to continue advancing our programs and platforms, and look forward to sharing updates as the year progresses."

Clinical Program Updates

Tumor-Specific Neoantigen (TSNA) Oncology Programs

GRANITE – Individualized, tumor specific neoantigen (TSNA)-directed immunotherapy using an adenoviral priming vector and self-amplifying mRNA boost vector to deliver relevant neoantigens

To date, an ongoing Phase 1/2 study assessing GRANITE in combination with an anti-PD-1 checkpoint inhibitor, nivolumab, and subcutaneous anti-CTLA-4 antibody, ipilimumab, has demonstrated a favorable safety and tolerability profile for patients treated in the study and demonstrated consistent induction of neoantigen-specific CD8+ T cells, and reduction in circulating tumor DNA (ctDNA), an increasingly recognized biomarker within utility in immunotherapy in advanced solid tumors.

Additionally, colorectal cancer patients who demonstrated a molecular response (ctDNA reduction >50% from baseline) had median overall survival of >17 months (median not reached) whereas those without molecular response exhibited a median overall survival of 7.8 months, the latter being consistent with expected outcome in 3rd line treatment of metastatic, microsatellite-stable colorectal cancer (MSS-CRC) patients. These data support the potential for GRANITE to offer benefit in a disease setting such as MSS-CRC where patients do not traditionally respond to checkpoint inhibitor therapy.

Given the results of the Phase 1/2 study, Gritstone has initiated two studies assessing GRANITE in earlier stages of disease: GRANITE-CRC-1L (a Phase 2/3 randomized, controlled trial evaluating the individualized neoantigen vaccine GRANITE in combination with immune checkpoint blockade for the first line (1L) maintenance treatment of newly diagnosed patients with metastatic MSS-CRC) and GRANITE-CRC-ADJUVANT (Randomized, controlled phase 2 trial of adjuvant GRANITE immunotherapy in high risk MSS-CRC patients with stage II/III disease who are ctDNA+ after definitive surgery). In January 2022, Gritstone announced the first patient was enrolled for inclusion in the GRANITE-CRC-1L trial. As of March 2022, the first patient was enrolled for inclusion in the GRANITE–CRC-ADJUVANT study.
SLATE – "Off-the-shelf" shared neoantigen-directed immunotherapy using an adenoviral priming vector and self-amplifying mRNA boost vector to deliver a cassette of shared TSNA

Preliminary data from an ongoing Phase 1/2 trial in advanced disease patients indicated a favorable safety and tolerability profile and induction of CD8+ T cells against multiple KRAS TP53 driver mutations. Clinical activity was observed in NSCLC patients who had all progressed on prior chemoimmunotherapy, including 6 NSCLC patients with the G12C KRAS mutation. Among these G12C patients, ctDNA responses were observed in 2 of 3 eligible for analysis, which correlated with clinical benefit, and a RECIST radiologic response (unconfirmed) was observed in one 2nd line patient with aggressive disease who had progressed after 3 months of 1st line chemo-immunotherapy. There were no safety signals of note; the most common adverse events being low grade, self-limiting fever and injection site reactions. An optimized SLATE cassette (SLATE-KRAS, v2), which exclusively includes KRASmut epitopes, exhibited immunogenic superiority over version 1 in preclinical studies. This next-generation SLATE-KRAS cassette is now in Phase 2 testing in patients with advanced non-small cell lung cancer (NSCLC) and CRC, and initial data are expected in 2H 2022.
Infectious Disease Programs

CORAL – second-generation SARS-CoV-2 vaccine program delivering both spike and highly conserved non-spike T cell epitopes (TCEs) with a focus on the samRNA vector. This approach offers potential for more durable clinical protection and broader immunity against SARS-CoV-2 variants than first generation products by inducing potent CD8+ T cells in addition to neutralizing antibody responses.

To date, the CORAL program has demonstrated positive preclinical and clinical data supporting the approach of a T cell enhanced samRNA vaccine against COVID-19, indicating a favorable safety profile and induction of both neutralizing antibodies and T cells.

In January 2022, Gritstone announced positive clinical data from the first cohort of CORAL-BOOST, a Phase 1 study evaluating the safety, reactogenicity, and immunogenicity of a samRNA vaccine directed against Spike and highly conserved non-Spike TCEs as a booster against SARS-CoV-2 in healthy adults ≥60 years who previously received two doses of AstraZeneca’s first-generation COVID-19 vaccine AZD1222 (Vaxzevria). Enrollment of the second cohort of CORAL-BOOST has since concluded and based on the favorable immunogenicity and reactogenicity seen with the 10µg dose, the study is proceeding to additional cohorts utilizing this dose.

Two additional Phase 1 trials, CORAL-CEPI and CORAL-IMMUNOCOMPROMISED, were initiated in 1Q 2022. The CORAL-CEPI trial, which is evaluating T cell enhanced omicron- and beta-spike constructs in virus-naïve, convalescent, and HIV+ patients, is being run in South Africa with support from the Coalition for Epidemic Preparedness Innovations (CEPI). The CORAL-IMMUNOCOMPROMISED trial, which is evaluating T cell enhanced samRNA and chimpanzee adenovirus (ChAd) vaccines in B cell deficient subjects, is being run in the United Kingdom.

CORAL-NIH, a Phase 1 study evaluating the immunogenicity and safety of samRNA and/or ChAd vaccines in healthy adult subjects that is supported by the National Institute of Allergy and Infectious Diseases (NIAID) is being conducted through their Infectious Diseases Clinical Research Consortium (IDCRC). Initial data is expected in 1H 2022.

All four clinical trials within the CORAL program are now enrolling and Gritstone expects to provide data updates on each of these trials throughout the remainder of 2022.
HIV – Collaboration with Gilead Sciences, Inc (Gilead) under their HIV Cure Program to research and develop vaccine-based HIV immunotherapy treatment

Following initiation of the collaboration with Gilead in early 2021, an IND was submitted and subsequently cleared in December 2021.
2021 Funding Highlights and Recent Corporate Updates

2021 Funding Highlights

Gritstone entered into a funding agreement of up to $20.6 million with the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the clinical development of Gritstone’s CORAL second generation mRNA COVID-19 vaccine program.
Gritstone secured $55 million Private Placement led by Frazier Life Sciences Public Fund, Redmile Group and Gilead Sciences.
Gritstone secured $60 million payment from Gilead at closing of HIV program collaboration, consisting of a $30 million upfront cash payment and a $30 million equity investment at a premium.
Recent corporate updates

The funding agreement with CEPI was expanded for up to $5 million to advance the clinical development of Gritstone’s CORAL second generation mRNA COVID-19 vaccine program targeting the omicron variant in South Africa (December 2021).
Clare Fisher, Senior Vice President of Business Development and Mergers & Acquisitions at BeiGene, was appointed to the Gritstone Board of Directors effective as of January 1, 2022 (December 2021).
Gritstone was added to the Nasdaq Biotechnology Index (December 2021).
Full Year 2021 Financial Results

Cash, cash equivalents, marketable securities and restricted cash were $223.5 million as of December 31, 2021, compared to $172.1 million as of December 31, 2020.
Research and development expenses were $97.5 million for the year ended December 31, 2021, compared to $88.6 as of December 31, 2020. The increase was primarily due to increases in personnel-related expenses and clinical trial expenses.
General and administrative expenses were $25.9 million for the year ended December 31, 2021, compared to $21.4 million as of December 31, 2020. The increase was primarily attributable to an increase in personnel-related costs as we expanded our headcount, and an increase in outside services for legal, finance, recruiting and other professional services to support our ongoing operations and operate as a public company.
Collaboration and license revenue was $46.7 million for the year ended December 31, 2021, compared to $3.5 million for the prior year. During the year ended December 31, 2021, we recorded $38.6 million in license revenue and $5.1 million in collaboration revenue related to the Gilead Collaboration Agreement, and $3.0 million in collaboration revenue related to the 2seventy bio Agreement.