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.

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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.

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]).

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"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.

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.

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"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.

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]).

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"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.

On March 3, 2022 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the fourth quarter and full-year ended December 31, 2021, and provided updated clinical data from the ongoing Phase 1b trial of ATRC-101 in select solid tumors (Press release, Atreca, MAR 3, 2022, View Source [SID1234609452]).

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"Last year was a highly productive year for Atreca with regard to both clinical development of ATRC-101 and the generation and advancement of other pipeline assets," said John Orwin, Chief Executive Officer. "We are pleased to report additional results from the ATRC-101 program today. The data continue to show a significant association between activity and target expression, and we’ve now observed a partial response in monotherapy along with a complete response in the pembrolizumab combination cohort. Given the relationship between activity and target expression, we are preparing to integrate a diagnostic for participant selection. We believe these data demonstrate that ATRC-101 has clinical activity, validating our platform and our approach to identifying potentially valuable therapeutic antibodies against novel targets in oncology. On the preclinical side, we look forward to presenting more information on our EphA2 program and other pipeline assets at an R&D day in April."

ATRC-101 Update

The Phase 1b trial is a first-in-human, open-label study of ATRC-101 in patients with select solid tumor cancers. The trial began with a dose escalation portion of five dose levels from 0.3 mg/kg to 30 mg/kg, which was completed last year with no dose-limiting toxicities observed. Patient enrollment is ongoing in a once-every-three-week (Q3W) monotherapy dose cohort, a once-every-two-week (Q2W) monotherapy dose cohort and combination dose cohort with pembrolizumab. Enrollment in the monotherapy cohorts is limited to patients with tumor types displaying greater than 50% immunoreactivity to ATRC-101 in preclinical studies, and greater than 30% in the combination cohort. The objectives of the study are to characterize safety, determine a maximum tolerated or recommended dose for future studies, measure initial anti-cancer activity, and characterize potential biomarkers of activity in tumors, plasma, and peripheral blood mononuclear cells (PBMC).
As of the data cut-off date of February 15, 2022, a total of 47 participants have been dosed in the trial and evaluated for safety, including 36 participants treated in the Q3W arm, 8 in the Q2W arm, and 3 in the combination arm. Thirty-eight of 47 participants were treated with doses of 3 mg/kg, 10 mg/kg or 30 mg/kg, which we believe are pharmacologically relevant. Participants enrolled in the study had received a median of five prior lines of treatment, and participants in the combination arm are required to have had prior anti-PD-1 or anti-PD-L1 therapy.
ATRC-101 has been generally well-tolerated, with no dose-limiting toxicities in the monotherapy or combination dose-escalation cohorts. Among the 47 participants enrolled, 16 (34%) had at least one grade ≥ 3 adverse event (AE). Only two grade 3 AEs were considered potentially treatment-related, which were headache and a small intestinal obstruction. The most common treatment-related AEs were fatigue (n=15, 32%) and nausea (n=12, 26%).
Target expression in tumor biopsies obtained at screening was significantly associated with anti-tumor activity in the 3,10 and 30 mg/kg cohorts. Among participants treated at the higher dose levels who were evaluable for target expression and response, stable disease (SD) (n=6), PR (n=1) or CR (n=1) was observed in 8 of 12 (66%) with a screening H-score ≥ 50 (high). By comparison, in such participants with a screening H-score < 50 (low), SD was observed in 2 of 12 (17%), and none achieved PR or better.
A confirmed CR was observed in a melanoma participant (H-score high) in the pembrolizumab combination cohort who had progressed on prior anti-PD-1 and combined BRAF/MEK inhibitor therapy. In the monotherapy cohorts, a participant with non-small cell lung cancer (H-score high) achieved PR with 48% reduction in tumor burden, and a participant with colorectal cancer (H-score unknown) experienced a 29% reduction. All three participants remain on study.
Enrollment is ongoing in the Q3W and Q2W monotherapy cohorts and in the pembrolizumab combination cohort. Atreca has now completed validation of the target diagnostic and is planning to begin participant selection based on target expression in 2Q22. Atreca expects to report additional monotherapy and combination data in 2H22.
"We are very encouraged by the safety profile and evidence of the anti-tumor activity of ATRC-101, both as a single agent and in combination with a checkpoint inhibitor," said Jonathan Benjamin, M.D., Ph.D., Senior Vice President, Clinical Research. "We are pleased to see stable disease with tumor burden reduction in several trial participants and are especially gratified that two participants achieved objective responses, including a 78-year-old participant with melanoma who had progressed on a prior anti-PD1 agent yet achieved a complete response with the combination of ATRC-101 and pembrolizumab. ATRC-101 recognizes a previously unknown ribonucleoprotein complex that is expressed selectively in tumor tissue of many different cancer types. Among participants with evaluable baseline tumor biopsies, tumor burden reduction was achieved exclusively in those with high ATRC-101 target expression. Selection of trial participants based on target expression will be important in further evaluation of ATRC-101 and is expected to begin by mid-year."

Other Recent Developments and Highlights

Atreca presented two posters on ATRC-101 at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.
Atreca disclosed data on its anti-SARS-CoV-2 antibody discoveries, originally planned for presentation at the Keystone Symposia Conference: Antibodies as Drugs, which was postponed. By applying its proprietary IRC technology, the company discovered antibodies from the immune responses of patients infected with the original SARS-CoV-2 virus, two of which were determined to be pan-neutralizing against a panel of SARS-CoV-2 variants, including Delta and more recently, Omicron.
Atreca will be hosting a pipeline-focused virtual R&D Day on April 5th, 2022. Topics to be covered include our EphA2 program, as well as other previously undisclosed antibodies against new targets in ADC, T cell engager and other weaponized formats, in addition to our non-oncology programs.
Fourth Quarter and Year End 2021 Financial Results

As of December 31, 2021, cash and cash equivalents and investments totaled $148.1 million.
Research and development expenses for the year ended December 31, 2021, were $78.3 million, including non-cash share-based compensation expense of $8.6 million. Research and development expenses for the three months ended December 31, 2021, were $22.2 million, including non-cash share-based compensation expense of $2.5 million.
General and administrative expenses for the year ended December 31, 2021, were $32.0 million, including non-cash share-based compensation expense of $8.3 million. General and administrative expenses for the three months ended December 31, 2021, were $7.3 million, including non-cash share-based compensation expense of $2.2 million.
Atreca reported a net loss of $109.3 million, or basic and diluted net loss per share attributable to common stockholders of $2.95, for the year ended December 31, 2021. The Company reported a net loss of $29.5 million, or basic and diluted net loss per share attributable to common stockholders of $0.79, for the three months ended December 31, 2021.
Conference Call and Webcast Details

Atreca will host a live conference call and webcast today at 4:30 p.m. EST. To access the conference call by telephone, please dial (800) 373-6606 (Domestic) or 409-937-8918 (International). The conference ID number is 5089907.

The live audio webcast and accompanying slide presentation can be accessed via the Events section of the Company’s investor relations website at View Source An archived replay of the webcast will be available on the Company’s website for 90 days following the live event.