On May 13, 2021 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 for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Terns Pharmaceuticals, MAY 13, 2021, View Source [SID1234579932]).

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"Our development team has continued to rapidly advance our NASH clinical programs, with top-line data for the Phase 2a LIFT study of FXR agonist TERN-101 in NASH now accelerated into June 2021. In the LIFT study, in addition to safety and tolerability, we are assessing multiple non-invasive endpoints, including MRI-PDFF (proton density fat fraction), a marker of steatosis, as well as ELF (enhanced liver fibrosis) and cT1 (MRI corrected T1) which are markers of fibrosis and/or inflammation linked to clinical outcomes and histological improvements in chronic liver diseases," said Senthil Sundaram, CEO at Terns. "In March, we initiated our first clinical trial of TERN-501 and look forward to announcing top-line data in the second half of 2021 that we hope will provide clinical confirmation of its high metabolic stability and differentiated pharmacokinetic profile."

Recent Developments and Anticipated 2021 Milestones
TERN-101: Liver-distributed farnesoid X receptor (FXR) agonist

Completed patient enrollment in the Phase 2a LIFT study in NASH patients in January 2021
Expecting top-line data from the Phase 2a LIFT study in June 2021
TERN-501: Thyroid hormone receptor-beta (THR-β) agonist

Initiated dosing in a first-in-human Phase 1 SAD/MAD clinical trial in March 2021
Expecting top-line data from the ongoing Phase 1 trial in 2H21
Composition of matter claims allowed by USPTO
TERN-201: Vascular adhesion protein-1 (VAP-1) inhibitor

Expecting to initiate dosing in 12-week Phase 1b clinical trial in NASH patients in 1H21 with expected top-line data in 1H22
GLP1-R: Oral, small-molecule receptor agonist

Expecting to nominate a final candidate in 2H21 for further development
Strengthened balance sheet

Completed an oversubscribed and upsized $147 million initial public offering in February 2021
Cash and equivalents support operations into 2024
Terns also announced today that Erin Quirk, M.D., will assume the position of Head of Research & Development, in addition to President and Chief Medical Officer, effective immediately. Weidong Zhong, Ph.D. will be leaving his position as Chief Scientific Officer and board member, effective as of July 2, 2021. In the interim, Dr. Zhong will continue to support Dr. Quirk to ensure a smooth transition.

Mr. Sundaram continued, "On behalf of our board and our entire team, I would like to thank Weidong for all of the contributions he made in founding Terns but also in successfully building and advancing our diverse NASH pipeline. At the same time, we are pleased to expand Erin’s title in recognition of her ongoing role in leading our research, development and manufacturing teams, which she has done since 2020. With Erin’s leadership, I am confident that we are well positioned to continue to advance our current and future pipeline candidates through all stages of research and development."

First Quarter Financial Results

Cash Position: As of March 31, 2021, cash, cash equivalents and marketable securities were $195.6 million as compared with $74.9 million as of December 31, 2020. Based on its current operating plan, Terns expects these will be sufficient to fund its planned operating expenses into 2024.
Research and Development (R&D) Expenses: R&D expenses were $8.7 million for the quarter ended March 31, 2021, as compared with $7.2 million for the quarter ended March 31, 2020.
General and Administrative (G&A) Expenses: G&A expenses were $4.6 million for the quarter ended March 31, 2021, as compared with $2.2 million for the quarter ended March 31, 2020.
Net Loss: Net loss was $13.3 million for the quarter ended March 31, 2021, as compared with $9.2 million for the quarter ended March 31, 2020.

On May 13, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported financial results for the first quarter ended March 31, 2021 and provided a business update (Press release, Silverback Therapeutics, MAY 13, 2021, View Source [SID1234579931]).

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"In our first quarter as a public company, our team continues to execute on Silverback’s mission to bring tissue-targeted therapies to patients in need," said Laura Shawver, Ph.D., chief executive officer of Silverback. "We are on track to report interim clinical data for SBT6050 in the second half of this year, and we are equally excited about the progress and preclinical data emerging from SBT6290 and SBT8230, highlighting the broad applicability of our ImmunoTAC platform."

Recent Highlights

SBT6050 (HER2-TLR8 ImmunoTAC) continues to advance through monotherapy and pembrolizumab combination dose escalation arms of the Phase 1/1b clinical study. Silverback is on track to deliver interim clinical data from the monotherapy dose escalation arm of the study in the second half of 2021.
GLP toxicology studies have commenced for SBT6290 (Nectin4-TLR8 ImmunoTAC), with an IND submission anticipated in the fourth quarter of 2021. Dosing has been initiated in the GLP toxicology study and GMP manufacturing of the Phase 1 clinical supply is underway. In April 2021, Silverback presented data at the American Association of Cancer Research Annual Meeting 2021. These preclinical data showed that SBT6290 activates human myeloid cells in a Nectin4-dependent manner and that a SBT6290 mouse surrogate confers single agent anti-tumor activity in preclinical studies.
SBT8230 (ASGR1-TLR8 ImmunoTAC for chronic HBV) continues to advance through preclinical development with CMC activities underway. GLP toxicology studies are expected to commence in the first quarter of 2022.
Appointed Maria Koehler, M.D., Ph.D. to Board of Directors. In March 2021, Silverback appointed Dr. Koehler, M.D., Ph.D. to its board of directors, bringing more than 20 years of clinical development leadership experience.
First Quarter Financial Results

For the first quarter ended March 31, 2021, Silverback reported a net loss of $18.9 million, compared to a net loss of $5.3 million for the comparable period in 2020. Net loss for the first quarter of 2021 included non-cash stock-based compensation expense of $4.3 million compared to $47,000 for the same period in 2020.

Research and development expenses for the first quarter ended March 31, 2021 were $12.2 million, compared to $4.4 million for the same period in 2020. The increases in the Company’s research and development expenses in 2021 were primarily attributable to the advancement of pipeline programs, including SBT6290 and SBT8230, into preclinical development and the continued development of SBT6050. Silverback also incurred additional personnel-related expenses as operations grew in support of program advances.

General and administrative expenses for the first quarter ended March 31, 2021 were $6.6 million, compared to $0.8 million for the same period in 2020. The increases in general and administrative expenses were primarily attributable to an increase in personnel-related expenses due to increased headcount in 2020, including new executives, as well as increases in salaries, bonuses, and stock-based compensation. The increases in general and administrative expenses were also due to an increase in legal fees, professional fees, and other various general and administrative expenses as we now operate as a public company.

As of March 31, 2021, Silverback reported cash and cash equivalents of $374.2 million, compared to $386.6 million at December 31, 2020, which is expected to fund operating expenses and capital expenditure requirements for at least the next 24 months.

On May 13, 2021 Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported financial results for the first quarter ended March 31, 2021 and provided an update on its clinical pipeline and other corporate developments (Press release, Conatus Pharmaceuticals, MAY 13, 2021, View Source [SID1234579930]).

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"We continue to focus on advancing our novel pipeline and are pleased to have initiated the emricasan study for treatment of mild symptomatic COVID-19 patients and are on track to initiate the HST-003 study for knee cartilage repair in the second quarter of 2021," said Richard W. Pascoe, President and Chief Executive Officer. We also welcomed Dr. Susan Windham-Bannister and Rochelle Fuhrmann to our Board of Directors. Both Sue and Rochelle bring to our board relevant industry experience with respective expertise in strategic growth and financial management, which will serve Histogen well. Looking forward, we will continue to focus on the initiation and execution of the HST-003 study, delivering top-line results of the emricasan COVID-19 trial, and completing our evaluation of the clinical development plans for the HST 001 program."

Highlights from the First Quarter Ended March 31, 2021 and Business Updates

HST-001 – In February 2021, we announced the final results from the week 26 assessments of our study of HST-001 for the treatment of androgenic alopecia in men. These results supported that HST-001 was shown to be safe and well tolerated as compared to placebo with no reports of serious adverse events but did not achieve statistical significance at week 26 as compared to placebo. Additional observations at week 26 included that 84% of patients treated with HST-001, as compared to baseline, demonstrated a statistically significant change in total hairs (terminal and vellus) within the target area (TAHC) of the vertex as measured by Canfield’s Hairmetrix macrophotography system. We are currently evaluating our clinical development plans for the HST-001 program and expect to complete our evaluation in the second quarter of 2021.

HST-003 – In March 2021, we announced that the U.S. Food and Drug Administration ("FDA") confirmed that we can proceed with the initiation of our planned Phase 1/2 clinical study of HST-003 to evaluate the safety and efficacy of human extracellular matrix (hECM) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure. We anticipate enrollment to commence in the second quarter of 2021. Patients will be enrolled at three sites: Oasis MD in San Diego, CA, The Steadman Clinic in Vail, CO, and Walter Reed Medical Center in Bethesda, MD.

Emricasan – In March 2021, we, in collaboration with our partner Amerimmune, announced dosing the first patient in the Phase 1 study of emricasan for the treatment of mild symptomatic COVID-19 patients. The study is designed to assess safety and tolerability and will also include various clinical and laboratory measures and patient reported outcomes (PROs) using the FDA COVID-19 Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Assessment tool. We, along with our partner Amerimmune, expect top-line data to be available in the second quarter of 2021.

Appointed Dr. Susan Windham-Bannister and Rochelle Furhmann to the board of directors – In March 2021, we continued to strengthen and diversify our board with the appointment of Dr. Windham-Bannister and Rochelle Fuhrmann. Dr. Windham-Bannister is an internationally recognized expert in innovation, market access and market optimization strategies. She has been recognized by Biosphere as one of the "10 Most Prominent African American Science Leaders," the Boston Globe as one of the "10 Most Influential Women in Biotech," by Boston Magazine as one of the "50 Most Powerful Women in Boston" and is the President of the National Board of Directors of the Association for Women in Science (AWIS). Dr. Windham-Bannister currently serves as Managing Partner of Biomedical Innovation Advisors LLC, which she founded with Dr. Harvey Lodish, co-founder of Genzyme, and member of the Whitehead Institute, MIT. She also serves as the President and CEO of Biomedical Growth Strategies, LLC. Ms. Fuhrmann currently serves as the Vice President Audit and Enterprise Risk Management at Becton Dickinson (BD). In 2016, Ms. Fuhrmann helped establish the BD Foundation, and she presently serves as Treasurer and as a member of its Board of Trustees. She joined BD in July 2015 as Senior Vice President and Chief Financial Officer, BD Life Sciences. Prior to joining BD, Rochelle held various positions responsible for the management of financial functions, including accounting and financial reporting, investor relations, corporate finance, risk management and treasury, primarily in the pharmaceutical industry with companies such as Amneal Pharmaceuticals and Warner Chilcott plc. She previously served as a member of the Board of Directors of Concordia International Corp. and held the position of Audit Committee Chairperson for three years.

Financings – In January 2021, we received $14 million of gross proceeds from an S-1 offering and as of March 31, 2021, an incremental $6.8 million of gross proceeds from the exercise of warrants associated with the January 2021 public offering.
First Quarter 2021 Financial Highlights

First Quarter Ended March 31, 2021 and 2020

Product and Service Revenues in the first quarter of 2021, revenue decreased 56% to $0.4 million from $1.0 million in the first quarter of 2020. The decrease is primarily related to revenue recognized during the first quarter of 2020 associated with the Allergan License Agreement amendments offset by first quarter 2021 revenue related to the final supply of cell conditioned medium ("CCM") to Allergan under the Allergan License Agreements.

Cost of revenues for the three months ended March 31, 2021 and 2020 were $0.2 million and $0.3 million, respectively. The cost of product revenue during the first quarter of 2021 is related to the final supply of CCM sold to Allergan as compared to $0.2 million of scrapped inventory and $0.1 million of costs associated with professional services during the first quarter of 2020.

Research and development expenses for the three months ended March 31, 2021 and 2020 were $2.2 million and $1.4 million, respectively. The net increase of $0.8 million for the three months ended March 31, 2021 as compared to the three months ended March 31, 2020 was primarily due to increases in expanded development costs of our product candidates partially offset by $0.2 million in qualifying reimbursable expenses in connection with the Department of Defense grant and increases in personnel related expenses.

General and administrative expenses for the three months ended March 31, 2021 and 2020 were $2.3 million and $1.2 million, respectively. The $1.1 million increase for the three months ended March 31, 2021 as compared to the three months ended March 31, 2020 was primarily due to incremental costs related to the transition from a private to a public exchange traded entity, such as legal, accounting and insurance fees and increases in personnel related expenses.

Cash and cash equivalents as of March 31, 2021 were $21.7 million. We believe that Histogen’s existing cash and cash equivalents and cash inflow from operations will be sufficient to meet its anticipated cash needs through the second quarter of 2022.

On May 13, 2021 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading edge computational and experimental technologies, reported first quarter 2021 financial results (Press release, Relay Therapeutics, MAY 13, 2021, View Source [SID1234579929]).

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"Since the start of 2021, we have been laser-focused on our mission for the year – execution. We continue to make progress on our clinical programs – RLY-1971, our SHP2 inhibitor partnered with Genentech, and RLY-4008, our FGFR2 inhibitor. Our PI3Kα mutant selective program is anticipated to enter IND enabling studies this year and we continue to advance our pipeline of precision oncology and genetic diseases programs," said Sanjiv Patel, M.D., president and chief executive officer. "We also made our first acquisition, ZebiAI, as we look to continually bolster our Dynamo platform and become a strategic partner of choice for emerging technologies."

Recent Corporate Highlights

Presented preclinical data for RLY-4008, a potent, selective and oral small molecule inhibitor of FGFR2, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021
Completed the IND transfer of RLY-1971 to Genentech, and Genentech remains on track for the start of a combination trial with their KRAS G12C inhibitor, GDC-6036, in 2021
Acquired ZebiAI, a pioneer in applying massive experimental DNA encoded library data sets to power machine learning for drug discovery (ML-DEL)
Strengthened clinical leadership with the appointments of Tara O’Meara as senior vice president of clinical development operations and Charles Ferté as global medical lead, RLY-4008
Expanded computational leadership with the addition of Patrick Riley as senior vice president of artificial intelligence
First Quarter 2021 Financial Results

Cash, Cash Equivalents and Investments: As of March 31, 2021, cash, cash equivalents and investments totaled approximately $726.1 million, compared to $678.1 million as of December 31, 2020. The Company expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2024. The increase in cash is primarily due to the receipt of Genentech’s $75 million upfront payment in the first quarter, partially offset by cash used to fund our operations.

R&D Expenses: Research and development expenses were $30.6 million for the first quarter of 2021, as compared to $21.7 million for the first quarter of 2020. This increase was primarily due to $5.5 million of additional employee related costs, including an increase in stock-based compensation of $3.3 million, $1.7 million related to increased clinical trial expenses associated with RLY-1971 and RLY-4008, and $1.3 million related to our pre-clinical candidates.

G&A Expenses: General and administrative expenses were $12.7 million for the first quarter of 2021, as compared to $4.8 million for the first quarter of 2020. This increase was primarily due to $6.2 million of increased personnel costs, including increased stock-based compensation of $5.0 million, to support our infrastructure and $1.7 million related to increases in other general and administrative expenses primarily attributed to an increase in insurance expense.

Net Loss: Net loss was $42.2 million for the first quarter of 2021, or a net loss per share of $0.47, as compared to a net loss of $24.9 million for the first quarter of 2020, or a net loss per share of $5.99.

On May 13, 2021 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, reported financial results for the first quarter 2021, and provided an update on its clinical development programs (Press release, Equillium, MAY 13, 2021, View Source [SID1234579928]).

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"During the quarter, we announced the first of multiple data catalysts across three indications expected in 2021 for itolizumab, highlighting its potential broad therapeutic utility," said Bruce Steel, chief executive officer at Equillium. "Data from the Type A group of patients in the Phase 1b EQUALISE study, our first from subcutaneous delivery, showed favorable safety and tolerability results in systemic lupus erythematosus patients. It also demonstrated a dose-dependent reduction in the pharmacodynamic marker of CD6 expression on effector T cells, and that these results were consistent with the promising data generated from intravenous dosing of itolizumab in the EQUATE study in acute graft-versus-host disease (aGVHD). We now look ahead to the EQUATE study where we expect to announce topline data before the end of this quarter, followed by regulatory feedback on our proposed pivotal study in first-line treatment of aGVHD in mid-2021. In the second half of the year we expect to announce data from the Type B group of patients with lupus nephritis in the EQUALISE study along with data from the EQUIP study in uncontrolled asthma."

2021 Year-to-Date Corporate & Clinical Highlights:

Announced favorable data from the Type A group of patients with systemic lupus erythematosus in the EQUALISE study, where itolizumab:
Was found to be safe and well tolerated
Demonstrated a dose-dependent reduction of cell surface CD6 expression on effector T cells, a leading indicator of drug activity, consistent with its mechanism of action
Demonstrated changes in pharmacodynamic markers observed with subcutaneous dosing were consistent with intravenous dosing of itolizumab
Presented positive interim data from the EQUATE study in patients with acute graft-versus-host disease at the following conferences:
2021 Transplantation and Cellular Therapy Meetings Digital Experience
European Society for Blood and Marrow Transplantation
Completed a registered direct offering with Decheng Capital on February 5, 2021, which raised $29.9 million in net proceeds, strengthening Equillium’s balance sheet and extending its expected cash runway into the second half of 2023
Strengthened the company’s leadership, including the following additions since the beginning of this year:
Dolca Thomas, M.D., appointed as executive vice president of research and development and chief medical officer
Y. Katherine Xu, Ph.D., partner at Decheng Capital, appointed to Equillium’s board of directors
Upcoming Catalysts:

EQUATE Phase 1b study: topline data in first-line aGVHD, 1H 2021
Regulatory feedback on proposed pivotal study in first-line aGVHD, mid-2021
Initiate pivotal study in first-line aGVHD, 2H 2021*
EQUALISE Phase 1b study: interim data from Type B patients (lupus nephritis), 2H 2021
EQUIP Phase 1b study: topline data in uncontrolled asthma, 2H 2021
*Proposed protocol & timeline for site initiation contingent on regulatory review

First Quarter 2021 Financial Results

Research and development (R&D) expenses for the first quarter of 2021 were $5.9 million, compared with $4.7 million for the same period in 2020. The increase in the first quarter of 2021 compared to the same period in 2020 was driven by an increase in clinical development expenses, primarily related to the EQUATE and EQUALISE studies as well as purchases of drug product from Equillium’s collaboration partner, Biocon, for Equillium’s ongoing clinical trials, greater headcount expenses, and greater research and translational science expenses. Those increases were partially offset by a reduction in overhead costs, primarily travel, and lower consulting expenses.

General and administrative (G&A) expenses for the first quarter of 2021 were $2.8 million, compared with $2.7 million for the same period in 2020. The increase in the first quarter of 2021 compared to the same period in 2020 was driven by greater headcount expenses, partially offset by lower consulting expenses, legal fees, and travel expenses.

Net loss for the first quarter of 2021 was $9.0 million, or $(0.33) per basic and diluted share, compared with a net loss of $7.8 million, or $(0.45) per basic and diluted share for the same period in 2020. The increase in net loss was largely attributable to increased research and development expenses.

Cash used in operations for the first quarter of 2021 was $7.9 million compared to $8.3 million in the fourth quarter of 2020.

Cash, cash equivalents and short-term investments totaled $104.1 million as of March 31, 2021, compared to $82.2 million as of December 31, 2020. The increase was due to the registered direct offering with Decheng Capital in February 2021, which raised $29.9 million in net proceeds. Equillium believes that its cash and investments will be sufficient to fund its currently planned operations into the second half of 2023.

About Itolizumab
Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.