1stOncology™: Cancer Intelligence Service – Page 6146 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Tyra Biosciences Reports Fourth Quarter and Full Year 2021 Financial Results and Highlights

On March 3, 2022 Tyra Biosciences, Inc. (Nasdaq: TYRA), a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer, reported financial results for the quarter and year ended December 31, 2021 and highlighted recent corporate progress (Press release, Tyra Biosciences, MAR 3, 2022, View Source [SID1234609457]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

"2021 was an important year of growth for TYRA and the progress we made has positioned us well for a meaningful 2022," said Todd Harris, CEO of TYRA. "We remain focused on execution across our pipeline and expect to submit Investigational New Drug Applications (INDs) to the U.S. Food and Drug Administration (FDA) this year for TYRA-300 and TYRA-200. In addition, we continue to advance our SNÅP chemistry platform with the goal to expand our pipeline through the nomination of clinical candidates from our FGFR3-related skeletal dysplasia, RET and FGFR4 programs."

Fourth Quarter 2021 and Recent Corporate Highlights

INDs for TYRA-300 and TYRA-200 on Track. During the fourth quarter of 2021, TYRA continued to advance TYRA-300, an FGFR3 inhibitor with an initial focus on patients with metastatic urothelial carcinoma of the bladder and urinary tract, and TYRA-200, an FGFR2 inhibitor with an initial focus on patients with intrahepatic cholangiocarcinoma. TYRA remains on track to submit an IND with the U.S. FDA for TYRA-300 in mid-2022 and for TYRA-200 in the second half of 2022.
Strengthened Clinical Team with Key Hire. During the fourth quarter of 2021, TYRA made the key senior appointment to its clinical team of Allison Kemner as Vice President, Clinical Sciences and Operations.
TYRA Added to Russell 2000 Index. On December 20, 2021, TYRA was added to the Russell 2000 Index as part of the index’s recent initial public offering additions. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Russell indexes are part of FTSE Russell, a leading global index provider.
Fourth Quarter and Full-Year 2021 Financial Results

Fourth quarter 2021 net loss was $9.9 million compared to $3.7 million for 2020.
Fourth quarter 2021 research and development expense was $7.2 million compared to $2.9 million for 2020.
Fourth quarter general and administrative expense was $2.7 million for 2021 compared to $0.8 million for 2020.
Full year 2021 net loss was $26.3 million compared to $9.3 million for 2020.
Full year 2021 research and development expense was $20.6 million compared to $7.2 million for 2020.
Full year 2021 general and administrative expense was $5.7 million compared to $2.1 million for 2020.
As of December 31, 2021, TYRA had cash and cash equivalents of $302.2 million.

Puma Biotechnology Reports Fourth Quarter and Full Year Financial Results

On March 3, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that financial results for the fourth quarter and year ended December 31, 2021 (Press release, Puma Biotechnology, MAR 3, 2022, View Source [SID1234609456]). Unless otherwise stated, all comparisons are for the fourth quarter and full year 2021, compared to the fourth quarter and full year 2020.

Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net for the fourth quarter of 2021 was $51.0 million, compared to product revenue, net of $50.0 million in the fourth quarter of 2020. Product revenue, net for the full year 2021 was $189.1 million, compared to product revenue, net of $196.7 million in 2020.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $4.2 million, or $0.10 per basic and diluted share, for the fourth quarter of 2021, compared to a net loss of $15.0 million, or $0.38 per basic and diluted share, for the fourth quarter of 2020. Net loss for the full year 2021 was $29.1 million, or $0.72 per basic and diluted share, compared to a net loss of $60.0 million, or $1.52 per basic and diluted share, for the full year 2020.

Non-GAAP adjusted net income was $8.4 million, or $0.21 per basic and diluted share, for the fourth quarter of 2021, compared to non-GAAP adjusted net loss of $5.5 million, or $0.14 per basic and diluted share, for the fourth quarter of 2020. Non-GAAP adjusted net income for the full year 2021 was $3.5 million, or $0.09 per basic share and $0.08 per diluted share, compared to non-GAAP adjusted net loss of $23.4 million, or $0.59 per basic and diluted share, for the full year 2020. Non-GAAP adjusted net income/loss excludes stock-based compensation expense. For a reconciliation of GAAP net income/loss to non-GAAP adjusted net income/loss and GAAP net income/loss per share to non-GAAP adjusted net income/loss per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the fourth quarter of 2021 was $5.4 million, compared to net cash used in operating activities of $5.6 million for the fourth quarter of 2020. Net cash provided by operating activities for the full year 2021 was $20.7 million, compared to net cash provided by operating activities of $0.8 million for the full year 2020. At December 31, 2021, Puma had cash, cash equivalents, and marketable securities of $82.1 million, compared to cash, cash equivalents, and marketable securities of $93.4 million at December 31, 2020.

"In the fourth quarter of 2021 Puma executed on its key milestones, which included the presentation of data from the SUMMIT trial at the 2021 San Antonio Breast Cancer Symposium," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We were also pleased to announce the extension of an additional five years to the U.S. patent term of NERLYNX during the quarter as well. We remain committed to providing neratinib to patients with HER2 positive breast cancer and we are grateful to the Puma team members, the physicians and scientists with whom we work, and, most importantly, the patients and caregivers we serve every day."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) conducting a pre-NDA meeting with the FDA to discuss accelerated approval of neratinib in HER2-mutated HR-positive breast cancer (H1 2022); (ii) reporting Phase II data from the cohort of patients in the SUMMIT basket trial of neratinib in HER2-mutated HR-positive breast cancer (H1 2022); (iii) reporting Phase II data from the cohort of patients in the SUMMIT basket trial of neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations (H2 2022); (iv) conducting a meeting with the FDA to discuss the potential for an accelerated approval pathway for neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations who have previously been treated with an EGFR tyrosine kinase inhibitor (2022); (v) reporting Phase II TBCRC-022 trial data from Cohort 4B and 4C of the combination of Kadcyla plus neratinib in patients with HER2-positive breast cancer with brain metastases who have previously been treated with Kadcyla (H2 2022); and (vi) reporting Phase II data from the SUMMIT trial of neratinib in cervical cancer patients with HER2 mutations (H2 2022)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, license revenue and royalty revenue. For the fourth quarter of 2021, total revenue was $55.4 million, of which $51.0 million was product revenue, net, $1.5 million was license revenue received from Puma’s sub-licensees and $2.9 million was royalty revenue. This compares to total revenue of $52.6 million for the fourth quarter of 2020, of which $50.0 million was net product revenue and $2.6 million was royalty revenue. For the year ended December 31, 2021, total revenue was $253.2 million, of which $189.1 million was product revenue, net, $51.8 million was license revenue received from Puma’s sub-licensees, which included a $50 million upfront payment for providing development, manufacturing and commercial rights to NERLYNX in Greater China to Pierre Fabre, and $12.3 million was royalty revenue. This compares to total revenue of $225.1 million for the year ended December 31, 2020, of which $196.7 million was product revenue, net, $22.7 million was license revenue, and $5.7 million was royalty revenue from Puma’s sub-licensees.

Operating Costs and Expenses

Total operating costs and expenses were $48.6 million for the fourth quarter of 2021, compared to $63.9 million for the fourth quarter of 2020. Total operating costs and expenses were $251.9 million for the full year 2021 compared to $255.5 million for the full year 2020.

Cost of Sales

Cost of sales was $11.9 million for the fourth quarter of 2021, compared to $10.9 million for the fourth quarter of 2020. Cost of sales was $63.7 million for the full year 2021, of which $20.0 million was a termination fee paid to a former sub-licensee for the return of commercial rights to NERLYNX in Greater China, compared to cost of sales of $39.4 million for the full year 2020.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $22.5 million for the fourth quarter of 2021, compared to $28.8 million for the fourth quarter of 2020. SG&A expenses for full year 2021 were $116.3 million, compared to $118.4 million for full year 2020, a decrease of $2.1 million. The decrease in SG&A expenses for the full year 2021 compared to 2020 resulted primarily from a decrease in payroll and related costs of $3.2 million due to a reduction in headcount, a decrease of $4.6 million in professional fees related to marketing and commercialization efforts, and a $2.0 million change due to a credit loss recovery related to an outstanding license payment, offset by an increase in stock-based compensation expense of $7.9 million.

Research and Development Expenses

Research and development (R&D) expenses were $14.2 million for the fourth quarter of 2021, compared to $24.2 million for the fourth quarter of 2020. R&D expenses for the full year 2021 were $71.9 million, compared to $97.7 million for the full year 2020. The decrease of $25.8 million in R&D expenses during full year 2021 compared to full year 2020 resulted primarily from a decrease in stock-based compensation expense of $11.9 million, a decrease in internal R&D expense of $5.7 million as a result of lower headcount and related compensation expense, and a decrease in clinical trial related expenses of $8.3 million due to the close out of certain clinical trials, a reduction in patient enrollments and monitoring cost and a reduction in consulting costs.

Total Other Income (Expenses)

Total other expenses were $2.4 million for the fourth quarter of 2021, compared to total other expenses of $3.7 million for the fourth quarter of 2020. Total other expenses were $30.1 million for the year ended December 31, 2021, compared to total other expenses of $29.4 million for the year ended December 31, 2020. The $0.7 million increase in other expenses for full year 2021 consisted primarily of an increase of $8.1 million related to a loss on extinguishment of debt, offset by decreases of $6.6 million related to legal verdict expenses and $1.3 million in interest expense.

Conference Call

Puma Biotechnology will host a conference call to report its fourth quarter and full year 2021 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PST/4:30 p.m. EST on Thursday, March 3, 2022. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

Rain Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Highlights Recent Progress

On March 3, 2022 Rain Therapeutics Inc. (NasdaqGS: RAIN), (Rain), a late-stage company developing precision oncology therapeutics, reported its financial results for the fourth quarter and full year ended December 31, 2021, along with an update on the Company’s key developments, business operations and upcoming milestones (Press release, Rain Therapeutics, MAR 3, 2022, View Source [SID1234609455]).

"Rain has achieved a number of important clinical milestones for milademetan including commencing two of the four planned trials in MDM2-dependent cancers. Rain dosed the first patient in the third quarter of last year and exceeded year-end 2021 targets for site activations for the pivotal, Phase 3 MANTRA trial in patients with liposarcoma and dosed the first patient in our Phase 2 MANTRA-2 basket trial in genetically selected patients with MDM2 gene amplification. We have also outlined two additional trials to start in the second half of this year, including the MANTRA-3 trial in patients with Merkel cell carcinoma, and our first combination trial MANTRA-4, with Roche’s anti-PD-L1 antibody, atezolizumab, in patients with advanced cancers exhibiting loss of the CDKN2A gene," said Avanish Vellanki, co-founder and chief executive officer of Rain.

Mr. Vellanki added, "We believe we have a strong capital position supporting completion of our ongoing and planned clinical trials, including an ample cash cushion for the Phase 3 MANTRA data timelines in liposarcoma. Further, considering the current capital markets picture in the biotech industry, we have taken steps to be even more prudent with capital to preserve the opportunity to generate data for milademetan across a diverse set of cancers."

Key Developments and Operational Updates

Phase 3 Dedifferentiated Liposarcoma Trial (MANTRA) is enrolling on schedule
Global site activations exceeded the target for year-end 2021, and all sites anticipated to be activated by the end of the first quarter of 2022. Enrollment in MANTRA trial on schedule.
Phase 2 Basket Trial (MANTRA-2) of Milademetan for MDM2-Amplified Advanced Solid Tumors
Rain dosed the first patient in its multicenter, open-label Phase 2 basket trial (MANTRA-2) in November 2021, evaluating milademetan in MDM2-amplified advanced solid tumors. Enrollment in MANTRA-2 trial on schedule.
Rain made significant progress in site activations for MANTRA-2 and anticipates all sites will be activated by the end of the first quarter of 2022.
Phase 2 Trial for Milademetan in Merkel Cell Carcinoma (MANTRA-3)
A Phase 2 clinical trial of milademetan as monotherapy in Merkel cell carcinoma (MCC) patients relapsed from first-line checkpoint inhibitors is anticipated to commence in the second half of 2022.
Rain Enters into Clinical Supply Agreement with Roche for the Supply of Atezolizumab in a Phase 1 Basket Trial in Advanced Solid Tumors Exhibiting Loss of the CDKN2A Gene (MANTRA-4)
In January 2022, Rain announced a clinical supply agreement with Roche for the supply of the anti-Programmed Death Ligand-1 (PD-L1) monoclonal antibody, atezolizumab.
A Phase 1 trial (MANTRA-4) is planned to evaluate the safety, tolerability and efficacy of milademetan in combination with Roche’s atezolizumab in patients with loss of CDKN2A and wild-type p53 advanced solid tumors and is anticipated to commence in the second half of 2022.
RAD52 Research Program
Continues to progress, with Rain-generated compounds exhibiting improved potency and selectivity versus the initial licensed portfolio.
Key Upcoming Milestones

Milademetan Dedifferentiated Liposarcoma Phase 3 Trial (MANTRA)
Top-line data anticipated in 2023
Milademetan MDM2-Amplified Phase 2 Basket Trial (MANTRA-2)
Interim data anticipated in the second half of 2022
Milademetan MCC Phase 2 Trial (MANTRA-3)
Phase 2 trial anticipated to commence in the second half of 2022
Milademetan Phase 1 Combination Trial (MANTRA-4)
Phase 1 trial anticipated to commence in the second half of 2022
Fourth Quarter Financial Results

For the three months and year ended December 31, 2021, Rain reported a net loss of $18.0 million and $51.4 million, respectively, as compared to a net loss of $5.4 million and $21.1 million for the same periods in 2020, respectively. Net loss per share for the three months and year ended December 31, 2021, was $0.68 and $2.65, respectively, as compared to a net loss per share of $1.56 and $6.29 for the same periods in 2020, respectively.

R&D expenses were $14.7 million and $40.8 million for the three months and year ended December 31, 2021, respectively, as compared to $4.2 million and $15.4 million for the same periods in 2020, respectively. The increases were primarily driven by the ongoing Phase 3 pivotal trial in dedifferentiated liposarcoma (MANTRA) and Phase 2 tumor-agnostic basket trial (MANTRA-2), as well as personnel costs. Non-cash stock-based compensation expenses included in R&D expenses were approximately $1.1 million and $2.5 million in the three months and year ended December 31, 2021, respectively, as compared to $0.2 million and $0.6 million in the same periods in 2020, respectively.

General and administrative (G&A) expenses were $3.4 million and $10.7 million for the three months and year ended December 31, 2021, respectively, as compared to $1.3 million and $3.6 million for the same periods in 2020, respectively. The increases were primarily due to higher costs associated with Rain becoming a public company, including the costs of director and officer insurance, personnel, legal, outside consulting, and accounting and audit fees. Non-cash stock-based compensation expense included in G&A expenses were approximately $0.2 million and $0.6 million for the three months and year ended December 31, 2021, respectively, as compared to $0.1 million and $0.3 million for the same periods in 2020, respectively.

Total non-cash stock-based compensation expenses were approximately $1.3 million and $3.1 million for the three months and year ended December 31, 2021, respectively, as compared to $0.3 million and $0.9 million for the same periods in 2020, respectively.

As of December 31, 2021, Rain had $140.2 million in cash, cash equivalents and short-term investments. Rain anticipates that its year-end cash position will provide runway into the first half of 2024, including completion of all its ongoing and planned clinical trials with an ample cash cushion for the Phase 3 MANTRA trial in liposarcoma.

As of December 31, 2021, Rain had approximately 26.5 million shares of common stock outstanding.

Fourth Quarter 2021 Results Conference Call and Webcast Details
The management of Rain Therapeutics will host a conference call and webcast for the investment community today, March 3, 2022 at 1:30 pm PT (4:30 pm ET). A live webcast may be accessed here: View Source The conference call can be accessed by dialing (833) 562-0127. The passcode for the conference call is 4729972.

Replay of the call will be available by visiting the "Events" section of the Rain website after the conclusion of the presentation and will be archived on the Rain website for 30 days.

About Milademetan

Milademetan (also known as RAIN-32) is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. Milademetan has already demonstrated antitumor activity in an MDM2-amplified subtype of liposarcoma (LPS) and other solid tumors in a Phase 1 clinical trial, supported by a rationally-designed dosing schedule to mitigate safety concerns and widen the therapeutic window of MDM2 inhibition. Milademetan is being evaluated in an ongoing Phase 3 clinical trial in patients with LPS (MANTRA), as well as a Phase 2 tumor-agnostic basket trial in certain solid tumors (MANTRA-2). Rain anticipates commencing a Phase 2 clinical trial of milademetan (MANTRA-3), for the treatment of patients with wildtype p53 Merkel cell carcinoma who are also refractory to immune checkpoint inhibition (ICI), in the second half of 2022, as well as a Phase 1 clinical trial to evaluate the safety, tolerability and efficacy of milademetan in combination with Roche’s atezolizumab in patients with loss of cyclin-dependent kinase inhibitor 2A (CDKN2A) and wildtype p53 advanced solid tumors (MANTRA-4), in the second half of 2022. Milademetan has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for patients with LPS.

Oncolytics Biotech® Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Operational Highlights

On March 3, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported recent operational highlights and financial results for the quarter and year ended December 31, 2021 (Press release, Oncolytics Biotech, MAR 3, 2022, View Source [SID1234609454]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

"We begin 2022 with a strong foundational dataset and potential value-inflection points expected across our pipeline throughout the year," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Chief among these potential inflection points is the expected fourth quarter top-line data announcement for BRACELET-1, our randomized phase 2 trial in HR+/HER2- metastatic breast cancer. This trial builds upon prior clinical data demonstrating pelareorep’s ability to deliver statistically significant survival benefits and synergize with checkpoint inhibition in breast cancer. Importantly, its completion represents the last major clinical step on our path to a registrational study."

Dr. Coffey continued, "Our efforts to advance towards our 2022 milestones are built upon the progress we made in 2021. Analyses from the AWARE-1 breast cancer trial highlight changes in peripheral blood T cell populations as a potential predictive biomarker that could markedly identify patients most likely to respond to pelareorep. The use of such a biomarker could improve our chances of success in subsequent trials and we are working to further its development as part of BRACELET-1. We are employing a similar strategy in our triple-negative breast and gastrointestinal cancer trials, which are showing positive progress following recent updates confirming the favorable safety profile of pelareorep-checkpoint inhibitor combinations. Looking ahead, we will continue to leverage partnerships with industry leaders and academia to advance pelareorep across a spectrum of indications while remaining primarily focused on completing the steps needed to begin a registrational breast cancer study."
Fourth Quarter and Subsequent Highlights

Breast Cancer Program

AWARE-1 data indicate that changes in peripheral blood T cell populations may be a predictive biomarker of pelareorep therapy

Recently announced analyses from AWARE-1’s first two cohorts focused on changes in T cell populations from the peripheral blood and tumors of early-stage HR+/HER2- breast cancer patients following treatment with pelareorep and letrozole without (cohort 1) or with (cohort 2) the PD-L1 inhibitor atezolizumab. These changes were compared to the CelTIL score (a measure of tumor cellularity and inflammation) and tumor-infiltrating CD8+ T cells, two metrics that are associated with favorable clinical outcomes. Collectively, the analyses reinforced pelareorep’s immunotherapeutic mechanism of action and its ability to synergize with checkpoint inhibitors such as atezolizumab. They also indicated that changes in peripheral blood T cell populations may predict responses to pelareorep therapy and could

potentially serve as a blood-based biomarker to inform the selection of patients in future studies. This has the potential to significantly de-risk a phase 3 registrational trial and supports expansion into indications that have historically not responded to checkpoint blockade therapies.

Reported a positive interim safety update from the phase 2 IRENE trial at the 2021 San Antonio Breast Cancer Symposium

IRENE is an investigator-sponsored, phase 2 trial designed to evaluate the safety and efficacy of pelareorep in combination with Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab for second- or third-line treatment of patients with metastatic triple-negative breast cancer (TNBC) who failed prior chemotherapy. Safety data from the trial show that the combination has been well-tolerated, as no safety concerns were noted in any of the five patients enrolled in the trial at the time of reporting (link to PR, link to poster). In addition to evaluating the safety and efficacy of pelareorep plus retifanlimab, IRENE is also designed to assess changes in PD-L1 expression and correlations between treatment outcomes and changes in peripheral blood T cell populations. This could provide a potential biomarker of pelareorep response that may enable the success of future trials by allowing for the early identification of patients most likely to respond to therapy.

Partner Adlai Nortye advanced to the second dose escalation cohort of the Chinese bridging trial evaluating pelareorep-paclitaxel combination treatment in breast cancer

The bridging clinical trial is designed to satisfy Chinese regulatory requirements and thereby accelerate pelareorep’s development in China, which comprises the world’s second-largest pharmaceutical market. Advancement into the trial’s second cohort followed the completion of dosing in the first cohort without any safety issues. The dose being evaluated in the second dose escalation cohort is equivalent to the dose administered in the IND-213 study, which reported a statistically significant near doubling of median survival in HR+/HER2- metastatic breast cancer patients. Results from the bridging trial are expected to allow Adlai Nortye to include data from IND-213 and Oncolytics’ ongoing North American metastatic breast cancer trial, BRACELET-1, in future submissions to regulators in China and its territories.

Gastrointestinal Cancers Program

Reported positive interim safety and enrollment updates from phase 1/2 GOBLET trial
The GOBLET trial is being conducted by AIO, a leading academic cooperative medical oncology group based in Germany, and is designed to evaluate the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with advanced or metastatic pancreatic, colorectal, and anal cancers. The study design was featured in a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (link to PR, link to poster) and included three-patient safety run-ins for two of its four cohorts (first-line advanced pancreatic cancer and third-line metastatic colorectal cancer). The pancreatic cancer cohort’s safety run-in is fully enrolled and has been evaluated by the study’s Data Safety Monitoring Board (DSMB). The DSMB noted no safety concerns and recommended the study proceed as planned. The safety run-in for the metastatic colorectal cancer cohort is fully enrolled and is awaiting DSMB review.

In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, GOBLET also seeks to assess the potential of CEACAM6 and T cell clonality as predictive biomarkers. An effective predictive biomarker could increase the likelihood of success of future registrational studies by allowing the selection of the most appropriate patients.

The trial builds on previously reported clinical proof-of-concept data for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer (link to PR, link to poster). It is also supported by prior early clinical data showing that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS-mutated colorectal cancer patients (link to PR, link to study) and a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster).
Corporate Highlights

Promoted Thomas C. Heineman, M.D., Ph.D., to Chief Medical Officer

Dr. Heineman has over two decades of experience successfully leading clinical development programs and previously served as Oncolytics’ Global Head of Clinical Development and Operations. Prior to joining Oncolytics, Dr. Heineman was Senior Vice President and Head of Clinical Development at Denovo Biopharma and Vice President and Head of Clinical Development at both Genocea Biosciences and Halozyme Therapeutics. At Halozyme, Dr. Heineman was also Head of Translational Medicine and oversaw clinical trials in indications such as breast and pancreatic cancer. Dr. Heineman’s experience further extends to big pharma and academia as he previously worked as Senior Director, Global Clinical Research and Development at GlaxoSmithKline and as an Associate Professor at the Saint Louis University School of Medicine.

Financial Highlights

•As of December 31, 2021, the Company reported $41.3 million in cash and cash equivalents.

•Operating expense was $3.8 million for the fourth quarter of 2021 and $13.3 million for the full year 2021, compared to $4.0 million in the fourth quarter of 2020 and $12.5 million for the full year 2020.

•R&D expense was $3.7 million for the fourth quarter of 2021 and $12.9 million for the full year 2021, compared to $4.1 million in the fourth quarter of 2020 and $12.9 million for the full year 2020.

•The net loss for the fourth quarter of 2021 was $7.8 million, compared to a net loss of $9.3 million in the fourth quarter of 2020. The basic and diluted loss per share was $0.14 in the fourth quarter of 2021, compared to a basic and diluted loss per share of $0.21 in the fourth quarter of 2020. The net loss for the full year 2021 was $26.3 million, compared to a net loss of $22.5 million for the full year 2020. The basic and diluted loss per share was $0.49 for the full year 2021, compared to a basic and diluted loss per share of $0.56 for the full year 2020.

•Net cash used in operating activities was $22.4 million for the full year 2021, compared to $22.1 million for the full year 2020.

Anticipated Milestones and Catalysts

•Completion of enrollment in phase 2 BRACELET-1 metastatic breast cancer study: Q1/Q2 2022

•Glioblastoma study update: H1 2022

•Multiple myeloma study data: H1 2022

•GOBLET 3rd-line metastatic colorectal cohort update: H1 2022

•GOBLET pancreatic cohort update: Q3 2022

•Top-line data from phase 2 BRACELET-1 metastatic breast cancer study: Q4 2022

Oncolytics expects to provide updates on the timing of the following milestones:

•Interim safety update from BRACELET-1 metastatic breast cancer study

Webcast and Conference Call
Management will host a conference call for analysts and institutional investors at 5:00 p.m. ET today, March 3, 2022. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 4650-7590. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 507-590.

Gossamer Bio Announces Fourth Quarter and Full-Year 2021 Financial Results and Provides Business Update

On March 3, 2022 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the fourth quarter and year ended December 31, 2021 and provided a business update (Press release, Gossamer Bio, MAR 3, 2022, View Source [SID1234609453]).

"After a considerable amount of planning and effort, the Gossamer team is excited to enter 2022 with two ongoing Phase 2 trials expected to readout this year," said Faheem Hasnain, Co-Founder, Chairman and Chief Executive Officer of Gossamer Bio.

"In the near term, we are eager to review GB004 Phase 2 SHIFT-UC 12-week topline data in patients with mild-to-moderate ulcerative colitis in the second quarter. We believe that, in contrast to other IBD therapies, GB004 has the potential to restore the epithelial barrier without systemic immune suppression. If this thesis bears out, GB004 could address the large swath of ulcerative colitis patients who are reticent to progress to systemic immunomodulatory or biologic agents, despite their disease being uncontrolled by 5-ASA therapy."

Clinical-Stage Product Candidate Updates

GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease (IBD)

Primary endpoint week 12 topline data from the Phase 2 SHIFT-UC study in patients with mild-to-moderate ulcerative colitis (UC) are expected in the second quarter of 2022.
Treat through week 36 topline data from the Phase 2 SHIFT-UC study in patients with mild-to-moderate UC are expected in the fourth quarter of 2022.
Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor for Pulmonary Arterial Hypertension (PAH)

Enrollment ongoing in the TORREY Study, a Phase 2 clinical trial in patients with PAH whose disease has progressed despite standard-of-care therapy. The primary endpoint is change in pulmonary vascular resistance from baseline at week 24. Topline data from the TORREY study are expected in the second half of 2022, subject to developments in the ongoing COVID-19 pandemic.
GB5121: Oral, CNS-Penetrant BTK Inhibitor for Primary CNS Lymphoma (PCNSL)

An investigational new drug (IND) application for GB5121 is now active, following a fourth quarter filing with the U.S. Food and Drug Administration (FDA).
Gossamer expects to initiate a global Phase 1b/2 clinical trial of GB5121 in PCNSL patients in the first half of 2022.
Financial Results for Quarter and Full Year Ended December 31, 2021

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2021, were $325.2 million. As a result, we currently expect cash, cash equivalents and marketable securities, and access to our debt facility will be sufficient to fund operating and capital expenditures into the second half of 2023.
Research and Development (R&D) Expenses: For the quarter ended December 31, 2021, R&D expenses were $40.9 million compared to R&D expenses of $38.9 million for the same period in 2020. R&D expenses for the full year ended December 31, 2021, were $170.3 million compared to $160.9 million for the full year ended December 31, 2020. The increase was primarily attributable to an increase of clinical trial and preclinical study costs associated with seralutinib, GB004, GB5121, and preclinical programs. This increase was partially offset by decreases in clinical trial and preclinical study costs related to GB001 and GB1275.
In-Process Research and Development (IPR&D) Expenses: There were no significant IPR&D expenses for the quarter and year ended December 31, 2021. For the quarter ended December 31, 2020, IPR&D expenses were $5.3 million. IPR&D expenses for the full year ended December 31, 2020, were $23.4 million.
General and Administrative (G&A) Expenses: For the quarter ended December 31, 2021, G&A expenses were $10.7 million compared to $15.9 million for the same period in 2020. G&A expenses for the full year ended December 31, 2021, were $45.8 million compared to $49.7 million for the full year ended December 31, 2020.
Net Loss: Net loss for the three months ended December 31, 2021, was $56.3 million, or $0.74 per share, compared to a net loss of $64.6 million, or $1.05 per share, for the same period in 2020. Net loss for the full year ended December 31, 2021, was $234.0 million, or $3.13 per share compared to a net loss of $243.4 million, or $3.55 per share, for the full year ended December 31, 2020.
Conference Call and Webcast

Gossamer’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Thursday, March 3, to discuss its fourth quarter and full year 2021 financial results and provide a corporate update.

The live audio webcast may be accessed through the "Events / Presentations" page in the "Investors" section of the Company’s website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

A replay of the audio webcast will be available for 30 days on the "Investors" section of the Company’s website, www.gossamerbio.com.