On March 3, 2022 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates to address serious diseases, such as non-alcoholic steatohepatitis (NASH) and obesity, reported financial results for the fourth quarter and full year ended December 31, 2021 and corporate highlights (Press release, Terns Pharmaceuticals, MAR 3, 2022, View Source [SID1234609460]).

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"2021 was a cornerstone year for Terns, during which we demonstrated monotherapy proof of concept for TERN-501 and TERN-101, nominated an oral small-molecule GLP-1 receptor agonist, TERN-601, as our development candidate to explore various metabolic diseases such as obesity, augmented our leadership team with key hires, and strengthened our financial position though our IPO," said Senthil Sundaram, chief executive officer at Terns. "We look forward to continuing our momentum with top-line data from the AVIATION trial of TERN-201 in NASH patients later this month. With four differentiated single-agent drug candidates under development, and our first combination therapy trial in NASH expected to initiate in the first half of 2022, we are rapidly advancing and broadening our pipeline to address serious diseases such as NASH and obesity."

Recent Developments and Anticipated Milestones

TERN-201: Vascular adhesion protein-1 (VAP-1) inhibitor

Top-line data from AVIATION Trial Part 1 (10 mg) and Part 2 (20 mg) expected in March 2022 and the second half of 2022, respectively, including:
Safety and tolerability
Key imaging endpoint: Corrected T1 (cT1), an imaging marker of liver inflammation and fibrosis linked to clinical outcomes
Serum markers: CK-18, ALT, plasma VAP-1 activity
Initiated Part 2 of Phase 1b AVIATION Trial in the first quarter of 2022
Part 2 will evaluate 20 mg of TERN-201 vs placebo for 12 weeks
TERN-501: Thyroid hormone receptor-beta (THR-β) agonist

Announced positive top-line single-ascending and multiple-ascending dose (SAD/MAD) data from Phase 1 proof of concept clinical trial in November 2021, including a presentation of SAD data at AASLD’s The Liver Meeting Digital Experience 2021, demonstrating:
Significant, dose-dependent effects on sex hormone binding globulin (SHBG), a key pharmacodynamic marker of THR-β engagement linked to NASH histologic efficacy
TERN-501 was generally well-tolerated
Predictable pharmacokinetic profile with low variability and median half-life supportive of once-daily dosing
Potential to be a best-in-class THR-β agonist monotherapy and the THR-β agonist of choice for coformulations of fixed-dose combinations for the treatment of NASH
Data support planned initiation in 1H 2022 of Terns’ first Phase 2a trial of TERN-501 alone and in combination with farnesoid X receptor (FXR) agonist TERN-101 in NASH patients with top-line data expected in 2H 2023
TERN-101: Liver-distributed FXR agonist

Announced positive data from Phase 2a LIFT Trial in NASH in June 2021, including multiple presentations at AASLD in November 2021, demonstrating:
TERN-101 was generally well-tolerated at all doses studied with no discontinuations due to adverse events, including pruritus
cT1, an imaging marker of liver inflammation and fibrosis linked to clinical outcomes, declined significantly as early as Week 6 with persistent decreases through Week 12 in all TERN-101 groups compared to placebo, with cT1 changes at Week 6 strongly correlated with changes at Week 12
TERN-101 treatment led to study population shifts to cT1 categories associated with lower risk of clinical events in chronic liver disease patients
In 5 and 10 mg groups of TERN-101, no differences from placebo in percentage change of low-density lipoprotein cholesterol and high-density lipoprotein cholesterol from baseline to Week 12
Data support planned initiation in 1H 2022 of Terns’ first Phase 2a trial of TERN-101 alone and in combination with THR-β agonist TERN-501 in NASH patients with top-line data expected in 2H 2023
TERN-601: Glucagon-like peptide-1 (GLP1) receptor agonist

TERN-601 candidate nominated at year-end 2021 as an oral, small-molecule GLP-1 receptor agonist targeting metabolic diseases such as obesity and NASH with the potential for once-daily dosing
Synthetic GLP-1 peptides have been approved for indications such as diabetes and obesity, which are conditions often accompanying NASH
Terns plans to engage in IND-enabling activities for TERN-601 with the goal of initiating a first-in-human clinical trial in 2023
Key Appointments

Diana Chung was promoted to senior vice president, chief development officer in January 2022, and was previously senior vice president, clinical development and operations at Terns
Jeffrey Jasper, Ph.D. joined Terns in December 2021 as senior vice president, head of research, bringing more than 28 years of experience in the biopharmaceutical industry
Ann E. Taylor, M.D. joined the Board of Directors in September 2021, bringing more than 35 years of experience in drug development, having served most recently as chief medical officer of AstraZeneca plc
Pamela Danagher joined Terns as vice president and head of regulatory affairs in August 2021, bringing more than 20 years of experience in the pharmaceutical and biotechnology sectors
Terns was appointed to the Steering Committee of the NAIL-NIT Consortium, a multi-stakeholder effort to link non-invasive tests (NITs) directly to liver-related outcomes and accelerate the usage of NITs as surrogate endpoints for NASH
Fourth Quarter and Full Year Financial Results

Cash Position: As of December 31, 2021, cash, cash equivalents and marketable securities were $166.0 million as compared with $74.9 million as of December 31, 2020. Terns completed an upsized initial public offering in February 2021, raising $146.6 million in gross proceeds. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2024, including through the clinical readout of its planned NASH Phase 2a combination trial of TERN-501 and TERN-101.
Research and Development (R&D) Expenses: R&D expenses were $9.5 million and $31.3 million for the quarter and year ended December 31, 2021, respectively, as compared with $7.8 million and $28.0 million for the quarter and year ended December 31, 2020, respectively.
General and Administrative (G&A) Expenses: G&A expenses were $5.4 million and $19.5 million for the quarter and year ended December 31, 2021, respectively, as compared with $1.0 million and $9.0 million for the quarter and year ended December 31, 2020, respectively.
Net Loss: Net loss was $14.2 million and $50.2 million for the quarter and year ended December 31, 2021, respectively, as compared with $9.9 million and $40.6 million for the quarter and year ended December 31, 2020, respectively.

On March 3, 2022 Geron Corporation (Nasdaq: GERN) reported that it will release its fourth quarter and full year 2021 financial results after the market closes on Thursday, March 10, 2022 via press release, which will be available on the Company’s website at www.geron.com/investors (Press release, Geron, MAR 3, 2022, View Source [SID1234609459]). Geron will host a conference call to discuss the financial results as well as upcoming milestones at 4:30 p.m. ET the same day.

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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.

On March 3, 2022 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, reported fourth quarter and full year 2021 financial results and provided a business update (Press release, NextCure, MAR 3, 2022, View Source [SID1234609458]).

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"In 2021, NextCure set the stage for multiple data readouts in 2022. This year, we intend to have important updates on NC318, NC410, and NC762," said Michael Richman, NextCure’s president and chief executive officer. "Additionally, we expect our year-end cash position of $219.6 million to fund us into the first quarter of 2024."

Business Highlights

NC318
Combined Phase 1 and 2 data presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting showed early evidence of potential clinical benefit in patients with lung cancer, squamous cell carcinoma of the head and neck, breast cancer and other advanced/metastatic solid tumors.
Preclinical data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting suggest that Siglec-15 (S15) may be targeted therapeutically with compounds such as NC318 to activate T lymphocytes against leukemia cells. Knock-out of S15 in a murine model resulted in leukemia clearance in immunocompetent recipients and 100% survival across all recipients.
NC410
Interim Phase 1 data presented at the SITC (Free SITC Whitepaper) Annual Meeting showed that NC410 appears to be safe and well-tolerated in patients with advanced tumors and demonstrated evidence of immune modulation.
Preclinical data published in the online journal Frontiers in Immunology indicated that collagen fragments in the tumor microenvironment (TME) can mediate T cell suppression through LAIR-1, and this suppression could subsequently be reversed by a LAIR-2 fusion protein like NC410.
NC762
Continued to enroll patients and advance the program to report initial Phase 1 clinical data in the second half of 2022.
NC525
Introduced our fourth program, which targets LAIR-1 expression with a novel mechanism of action that kills acute myeloid leukemia (AML) blasts and leukemia stem cells with minimal effect on hematopoietic stem and progenitor cells.
Preclinical data presented at the ASH (Free ASH Whitepaper) Annual Meeting appear to show that NC525 could preferentially target and kill LAIR-1 expressing AML stem cells with minimal effect on healthy hematopoietic stem and progenitor cells.
Appointed Ellen G. Feigal, M.D., a Partner and Head of the Biologics Practice at NDA Partners LLC, and Anne Borgman, M.D., former Vice President and Global Therapeutic Area Lead, Hematology-Oncology, at Jazz Pharmaceuticals, to the Board of Directors.
Appointed Elizabeth Jaffee, M.D., Ursula Matulonis, M.D., and Weiping Zou, M.D., Ph.D., to the NextCure Scientific Advisory Board.
Expected Upcoming Milestones

The widespread impact of the COVID-19 pandemic, including the emergence of the Omicron variant, has impacted enrollment and operations at certain clinical trial sites involved in NextCure’s ongoing trials. As a result, some milestones have been delayed. NextCure has taken multiple steps intended to drive enrollment and will continue to institute measures designed to mitigate the impact of the pandemic.

NC318 Phase 2 update: fourth quarter of 2022 (Amended Phase 2: S15+ selection with CLIA assay, 800 mg dosed Q1W).
NC318 anti-PD-1 Combo (Yale University Investigator-Initiated trial): second half of 2022.
NC410 Phase 1 update: second half of 2022.
NC762 initial Phase 1 data: second half of 2022.
NC525 Investigational New Drug Application (IND) filing: fourth quarter of 2022.
Financial Guidance

Based on its current research and development plans, NextCure expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditures into the first quarter of 2024.

Financial Results for Fourth Quarter and Full Year Ended December 31, 2021

Cash, cash equivalents, and marketable securities, excluding restricted cash as of December 31, 2021, were $219.6 million as compared with $283.4 million as of December 31, 2020. The decrease of $63.8 million as of December 31, 2021, as compared to December 31, 2020, primarily reflects cash used to fund operations of $57.2 million.
Research and development expenses were $50.2 million and $12.3 million for the year and quarter ended December 31, 2021, respectively, as compared with $46.6 million and $12.1 million for the year and quarter ended December 31, 2020, respectively. The increase was driven primarily by clinical-related and personnel-related costs, partially offset by timing of research and manufacturing supply costs.
General and administrative expenses were $20.6 million and $4.8 million for the year and quarter ended December 31, 2021, respectively, as compared with $17.0 million and $4.1 million for the year and quarter ended December 31, 2020, respectively. The increase was primarily related to personnel-related costs.
Revenue was not recognized for the year ended December 31, 2021, as compared with $22.4 million for the year ended December 31, 2020. Revenue generated in 2020 was from our former research and development agreement with Eli Lilly.
Net loss was $69.4 million and $16.9 million for the year and quarter ended December 31, 2021, respectively, as compared with $36.6 million and $15.5 million for the year and quarter ended December 31, 2020, respectively. The changes in net loss for the year and quarter were primarily due to increased research and development expenses and increased general and administrative expenses from an increase in headcount, offset by the recognition for the year ended 2020 of the remaining deferred revenue under the former research and development agreement with Eli Lilly.

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]).

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"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.

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.