On May 16, 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), obesity and cancer, reported financial results for the first quarter ended March 31, 2022 and business updates (Press release, Terns Pharmaceuticals, MAY 16, 2022, View Source [SID1234614641]).

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"The Terns team has continued to advance our pipeline with the opening of our combination therapy IND for NASH and the commencement of key IND-enabling activities in our GLP-1 program in obesity, along with the initiation of a clinical trial for TERN-701 in chronic myeloid leukemia by Hansoh, our development partner in China," said Senthil Sundaram, chief executive officer at Terns. "As we continue this momentum across our diverse pipeline, we remain committed to a prudent approach to funding our operations. Following a strategic review of our pipeline, we have decided to focus our resources on advancing our most promising pipeline candidates: (1) TERN-501, including combination therapy development with TERN-101, (2) TERN-601, our oral, small-molecule GLP-1 candidate, and (3) supporting our partner’s clinical development of TERN-701 for CML in China. This decision extends our expected cash runway into 2025, enabling key expected clinical trial readouts across three indications for TERN-501, TERN-601, and TERN-701 during that time period."

Recent Developments and Anticipated Milestones

TERN-501: Thyroid hormone receptor-beta (THR-β) agonist for NASH

TERN-501 is a THR-β agonist with high metabolic stability, enhanced liver distribution and greater selectivity for THR-β compared to other THR-β agonists in development
Investigational new drug (IND) application for Terns’ NASH combination therapy program was opened in April 2022, supporting the planned Phase 2a clinical trial of TERN-501 as monotherapy and in combination with TERN-101 (Terns’ liver-distributed farnesoid X receptor (FXR) agonist), as well as future studies of other combination therapy regimens
The Phase 2a trial is a multicenter, randomized, double-blind, placebo-controlled clinical trial in noncirrhotic NASH patients using a factorial design including both monotherapy and combination arms of TERN-501 and TERN-101
The trial is expected to enroll approximately 140 adult patients with elevated body mass index (BMI ≥ 25 kg/m2) and NASH with fibrosis, but not cirrhosis, based on prior liver biopsy and/or imaging and clinical criteria
All patients must have liver fat content measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF) of ≥10%, MRI corrected T1 (cT1) relaxation time of ≥ 800 msec, and meet other inclusion and exclusion criteria
The trial includes a 12-week treatment period and a 4-week follow-up period
The primary endpoint will be the relative change from baseline in MRI-PDFF at Week 12 for TERN-501 monotherapy compared with placebo
Secondary endpoints include assessment of changes in MRI-PDFF (combination vs. placebo) and cT1 (TERN-501 monotherapy vs. placebo as well as 501+101 combination vs. placebo)
IND has been opened in the United States; Phase 2a trial has been initiated with screening expected to start in June 2022, and top-line data expected in the second half of 2023
TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist for obesity

TERN-601 is an oral small-molecule glucagon-like peptide-1 receptor, or GLP-1R, agonist for the treatment of obesity
Terns screened more than 20,000 molecular permutations through its proprietary quantitative structure activity relationship (QSAR) model to identify suitable small-molecule scaffolds with potentially improved properties relative to other GLP-1-based approaches
Terns has identified structures believed to be suitable for oral administration as a single-agent or in combination with other drug candidates within its pipeline
IND-enabling activities for TERN-601, Terns’ lead GLP-1R development candidate, are underway with the goal of initiating a first-in-human clinical trial in 2023
The Phase 1 clinical program for TERN-601 is expected to include a single ascending dose trial in healthy volunteers and a multiple ascending dose proof-of-concept trial assessing potential endpoints such as body weight and HbA1c
TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor (TKI) for chronic myeloid leukemia

TERN-701 is Terns’ proprietary, allosteric BCR-ABL TKI, designed to target the ABL myristoyl pocket, which is in development for the treatment of chronic myeloid leukemia (CML), a form of cancer that begins in the bone marrow
TERN-701 was designed with the goal of achieving improved tumor suppression against a broader range of mutations, an enhanced pharmacokinetic profile with an increased half-life and simplified dosing compared to the only available allosteric BCR-ABL TKI, recently approved by the FDA
TERN-701 is out-licensed to Hansoh Pharmaceutical Group Company Limited for development in the greater China region (referred to as HS-10382 by Hansoh); Terns retains all worldwide development and commercialization rights outside of greater China, as well as access to data generated by Hansoh in China
A Phase 1 trial of TERN-701 in CML patients in China has been initiated by Hansoh, with patient dosing currently underway; Hansoh is responsible for all development and commercialization-related activities in greater China
Terns plans to explore options for the development and commercialization of TERN-701 outside of greater China, including additional strategic partnerships
TERN-201: Vascular adhesion protein-1 (VAP-1) inhibitor

Terns reported top-line results from Part 1 of the Phase 1b AVIATION Trial in March 2022
Part 1 of the AVIATION Trial met the primary safety endpoint: TERN-201 10 mg administered once daily to NASH patients was generally safe and well-tolerated with no meaningful changes in exploratory serum or imaging NASH biomarkers, including cT1
Further spend for TERN-201 in NASH has primarily been limited to the completion of Part 2 (20 mg dose) of the ongoing AVIATION Trial with results expected in 4Q 2022; Terns plans to evaluate all AVIATION data at that point to inform next steps for clinical development in NASH or other indications where VAP-1 is implicated
Business Update

Terns completed a proactive and financially disciplined review of the Company’s operations, resulting in the prioritization of resources towards development activities related to TERN-501 (including the planned Phase 2a clinical trial of TERN-501 as monotherapy and in combination with TERN-101) and the GLP-1R agonist program, including TERN-601, and supporting Hansoh’s clinical development of TERN-701 for CML in China
As a result of these decisions, Terns anticipates existing cash to be sufficient to fund operations into 2025, including three expected clinical trial readouts for three product candidates across three indications during that time period
Upcoming Investor Events

Terns will present at the UBS Global Healthcare Conference on Monday, May 23, 2022 at 8:30am ET. A live webcast of the event will be available on the investor relations page of the Terns Pharmaceuticals website at View Source A replay of the webcast will be archived on Terns’ website for 30 days following the presentation
First Quarter 2022 Financial Results

Cash Position: As of March 31, 2022, cash, cash equivalents and marketable securities were $151.3 million, as compared with $166.0 million as of December 31, 2021. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2025.
Research and Development (R&D) Expenses: R&D expenses were $8.1 million for the quarter ended March 31, 2022, as compared with $8.7 million for the quarter ended March 31, 2021.
General and Administrative (G&A) Expenses: G&A expenses were $5.7 million for the quarter ended March 31, 2022, as compared with $4.6 million for the quarter ended March 31, 2021.
Net Loss: Net loss was $13.8 million for the quarter ended March 31, 2022, as compared with $13.3 million for the quarter ended March 31, 2021.

On May 16, 2022 Scholar Rock (NASDAQ: SRRK), a Phase 3 clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported financial results for the first quarter ended March 31, 2022 (Press release, Scholar Rock, MAY 16, 2022, View Source [SID1234614640]).

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Business Strategy & Update

Prioritize R&D Activities to Support Progression and Completion of the Apitegromab Phase 3 SAPPHIRE Trial in Spinal Muscular Atrophy. Scholar Rock is focusing its expertise in inhibiting the activation of latent growth factors on completing the Phase 2 TOPAZ extension clinical trial and the Phase 3 SAPPHIRE clinical trial, both of which are evaluating the potential of apitegromab to address motor function impairments in patients with spinal muscular atrophy (SMA). The SRK-181 program for the treatment of patients with solid tumors showing primary resistance to anti-PD-(L)1 therapy remains a priority with strategic value. While investment in the existing scientific platform continues, the Company is narrowing the scope of discovery programs it expects to pursue.
Focused Strategy to Increase Operational Efficiency, Reduce Cash Burn and Extend Runway. The Company reported a restructuring of its business to prioritize and focus on its clinical stage assets resulting in a reduction to its workforce by approximately 25%, in addition to the curtailment of previously planned hiring. The reduction in operating expenses relates to general and administrative spend and research activities related to earlier stage programs. In conjunction with the pipeline prioritization, these changes are expected to extend the cash runway into the fourth quarter of 2023.
"We are highly confident in the transformative potential of apitegromab based upon the Phase 2 TOPAZ data we have released to date. We look forward to presenting two-year extension trial data in the coming weeks," said Nagesh Mahanthappa, Ph.D., Founding Chief Executive Officer of Scholar Rock. "Based upon the strength of the data released to date and our commitment to the SMA community, this narrower focus and associated headcount reduction is necessary to execute our core mission — completing the Phase 3 SAPPHIRE trial to bring apitegromab, our highly innovative therapeutic candidate, to patients suffering with this devastating disease."

Dr. Mahanthappa continued, "Parting with employees who have dedicated their talent and expertise to evolving a scientific platform into a Phase 3-stage company is very difficult, and we are extremely grateful for their contributions to our mission to support patients and help position us to potentially deliver the next big innovation to patients with SMA."

Changes to Development Leadership

The Company also announced today that Yung Chyung, M.D. has decided to step down as Chief Medical Officer (CMO) to explore new career opportunities, including his interest in global health. Dr. Chyung will remain with Scholar Rock through June 30 to work with the executive team and the development organization on a transition plan, and a retained search for a new CMO is ongoing.

"I am incredibly proud of the progress we’ve achieved to date at Scholar Rock and am humbled to have served alongside the amazing and talented employees across the company," said Dr. Chyung. "I am enthusiastic about the potential of apitegromab and SRK-181 to transform the lives of individuals impacted by serious diseases. With operational momentum continuing to build and the outstanding, high performing teams in place, I feel this is an appropriate time for me to explore my other long-term career interests, such as global health."

"The Board and I sincerely thank Yung for his ingenuity and leadership over the years, which have brought the apitegromab program forward through a successful Phase 2 proof-of-concept study and now into Phase 3, creating hope for patients and families suffering from SMA that muscle-directed therapy could have the potential to make a meaningful impact on their lives," said Dr. Mahanthappa. "While the search for a new CMO is a top priority and we are committed to identifying a medical leader with a strong track record in late-stage drug development and product launch, the significant depth of talent in our development team allows us to continue to build momentum in the SAPPHIRE pivotal and Phase 1 DRAGON proof-of-concept clinical trials without disruption."

Pipeline Updates

Apitegromab is a selective inhibitor of myostatin activation being developed as the potential first muscle-directed therapy for the treatment of spinal muscular atrophy (SMA).

Enrollment Ongoing for Phase 3 SAPPHIRE Clinical Trial Evaluating Apitegromab in Patients with Non-Ambulatory Type 2 and 3 SMA. The randomized, double-blind, placebo-controlled Phase 3 SAPPHIRE clinical trial is evaluating apitegromab for patients on either nusinersen or risdiplam. The clinical trial design plans for approximately 156 patients aged 2-12 years old with non-ambulatory Type 2 and 3 SMA to be enrolled in the main efficacy population.
Clinical Data from the Phase 2 TOPAZ 24-Month Extension Trial to be Presented at Cure SMA Annual Meeting in June.
Data from the Phase 2 TOPAZ Trial Presented at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference and the American Academy of Neurology Annual Meeting in March, as well as the European Paediatric Neurology Society Congress in April.
SRK-181 is a selective inhibitor of latent TGFβ1 activation being developed with the aim of overcoming primary resistance to and increasing the number of patients who may benefit from checkpoint inhibitor therapy.

Enrollment Ongoing for Part B of the Phase 1 DRAGON POC Clinical Trial for SRK-181. Part B consists of multiple proof-of-concept cohorts focused upon evaluating the ability of SRK-181 to overcome primary resistance to anti-PD-(L)1 therapy. Each cohort will enroll up to 40 patients with various solid tumors, including urothelial carcinoma (UC), cutaneous melanoma (MEL), non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma (ccRCC), and other solid tumors. The biomarker strategy in part B of DRAGON will explore early signs of SRK-181 activity, including target engagement and pathway modulation. This will include measuring effects on both circulating and tumor immune contexture, such as CD8+ T cell infiltration and reductions in myeloid-derived suppressor cell (MDSC) populations as well as analysis of TGFβ-related pathway signaling. Initial evidence of drug activity and safety data are anticipated in 2022.
First Quarter 2022 Financial Results

For the quarter ended March 31, 2022, net loss was $8.0 million or $0.21 per share compared to a net loss of $27.7 million or $0.76 per share for the quarter ended March 31, 2021.

Revenue was $33.2 million for the quarter ended March 31, 2022 compared to $4.7 million for the quarter ended March 31, 2021 and was related to the Gilead fibrosis-focused research collaboration, which was executed in December 2018 and concluded in December 2021.
Research and development expense was $29.4 million for the quarter ended March 31, 2022 compared to $22.5 million for the quarter ended March 31, 2021. The increase year-over-year primarily reflects increased clinical costs associated with apitegromab and higher personnel costs. The Company expects research expenses to decline beginning in the third quarter of 2022 due to the portfolio updates and workforce reduction announced today.
General and administrative expense was $10.8 million for the quarter ended March 31, 2022 compared to $9.4 million for the quarter ended March 31, 2021. The increase year-over-year was primarily attributed to higher personnel costs. As a result of our reduction in force, we expect our employee-related expenses to decline in the second half of the year as compared to the first half of 2022.
As of March 31, 2022, Scholar Rock had cash, cash equivalents, and marketable securities of approximately $210 million. The Company expects that the updates and changes announced today will fund its anticipated operating and capital expenditure requirements into the fourth quarter of 2023.
"While we have paused many of our discovery programs, we are continuing to progress selected pre-clinical programs which best exemplify the value of our platform. As a platform company, business development remains an important part of our strategy and we continue to explore partnerships for these programs which could be a source of non-dilutive capital in the future," said Ted Myles, Chief Operating Officer and Chief Financial Officer at Scholar Rock. "Our streamlined focus and structure allow us to channel the majority of our resources to supporting the SAPPHIRE trial and SRK-181, which we believe are key near- and long-term value drivers."

On May 16, 2022 Celularity Inc. (Nasdaq: CELU) ("Celularity" or the "Company"), a clinical-stage biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies, reported financial results for the first quarter ended March 31, 2022, and provided a corporate update (Press release, Celularity, MAY 16, 2022, View Source [SID1234614639]).

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"We have continued to achieve multiple transformational milestones and make significant progress this year with three ongoing Phase 1 clinical trials of two investigational drugs, CYNK-001 and CYNK-101, both of which have been granted Fast Track and Orphan Drug Designations for certain indications," said Robert J. Hariri, M.D., Ph.D., Founder, Chairperson and Chief Executive Officer of Celularity. We expect to have data readouts for all three ongoing Phase 1 programs later this year. As such, we believe we are well-positioned to continue executing our business strategy and developing cellular therapies for cancer, infectious and degenerative diseases that leverage our proprietary placental-based technology platform."

First Quarter Clinical and Regulatory Updates

CYNK-001 for the Treatment of AML and GBM:

CYNK-001 is Celularity’s unmodified cryopreserved human placental hematopoietic stem cell-derived NK cell therapy candidate that is enriched with CD56+/CD3- NK cells and expanded from human placental CD34+ cells. CYNK-001 is currently being investigated in two Phase 1 clinical trials, in AML and in GBM, with data readouts expected in the second half of 2022.
Celularity continues to enroll new cohorts in both arms of the Phase 1 AML study with clinical trial protocol adjustments communicated in December 2021, which include an addition of interleukin-2 (IL-2) to the treatment regimen; a fourth dose on day 21; and an increase in the dose of NK cells.
CYNK-101 for the Treatment of Gastric Cancer:

CYNK-101 is a novel allogeneic off-the-shelf human placental CD34+-derived NK cell product candidate that is genetically modified to express high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant to drive antibody-dependent cell-mediated cytotoxicity. CYNK-101 is currently being investigated in the Phase 1 portion of a Phase 1/2a clinical trial in advanced HER2+ gastric cancer.
In January 2022, the FDA granted Fast Track designation to CYNK-101, which is being developed in combination with standard chemotherapy, trastuzumab and pembrolizumab in first-line locally advanced unresectable or metastatic HER2/neu positive gastric/gastroesophageal (G/GEJ) adenocarcinoma.
In February 2022, the FDA granted Orphan Drug Designation to CYNK-101 for the treatment of G/GEJ cancer.
CYCART-19 for the Treatment of B-Cell Malignancies:

CYCART-19 is an allogeneic Chimeric Antigen Receptor (CAR) engineered human placental-derived T cell that is a potential drug candidate in B-cell malignancies.
Preclinical data demonstrating the feasibility and functionality of expressing a CAR directed to CD19 on placental CD34+derived, cryopreserved, off-the-shelf, allogeneic CYNK cells were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021.
Celularity submitted an Investigational New Drug (IND) application to FDA to investigate CYCART-19 for the treatment of B-cell malignancies in the first quarter of 2022 and in April 2022, received email notification from FDA that it will be requesting additional information before Celularity can proceed with the planned Phase 1/2 clinical trial. Celularity anticipates a formal written communication by late May 2022 and plans to work with the FDA in an effort to resolve its questions as promptly as possible and, if the IND is cleared, commence a Phase 1/2 clinical trial of CYCART-19 in B-cell malignancies in the second half of 2022.
First Quarter 2022 Financial Results

Cash and Cash Equivalents: Cash, cash equivalents and marketable securities were $48.0 million as of March 31, 2022, compared to $37.2 million as of December 31, 2021. In March 2022, we amended and restated certain warrants to reduce the exercise price per share to $3.50 per share, among other items, following which the holders exercised such warrants in full for cash for approximately $46.5 million and we issued the holders an aggregate 13,281,386 shares of our Class A common stock.
Total Revenues: Total revenues were $5.9 million for the first quarter of 2022, compared to $2.7 million for the first quarter of 2021. This increase in revenues was primarily driven by sales activity from supply and distribution agreements for Celularity’s degenerative disease products.
Research & Development (R&D) Expenses: R&D expenses were $21.7 million for the first quarter of 2022, compared to $17.0 million for the first quarter of 2021. The increase was primarily driven by higher clinical development expenses.
Selling, General & Administrative (SG&A) Expenses: SG&A expenses were $16.5 million for the first quarter of 2022, compared to $7.6 million for the first quarter of 2021. The increase in SG&A expenses was primarily caused by higher expenses related to being a public company, such as stock-based compensation, insurance and consulting fees.
Net loss: Net loss for the first quarter of 2022 was $62.9 million, or $(0.48) per share for both basic and diluted shares. Net loss for the first quarter of 2021 was $81.5 million, or $(3.40) per share for both basic and diluted shares.

On May 16, 2022 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, reported that Ryan Spencer, Chief Executive Officer, will present at the H.C. Wainwright Global Investment Conference, being held May 23-26, 2022 (Press release, Dynavax Technologies, MAY 16, 2022, https://investors.dynavax.com/news-releases/news-release-details/dynavax-present-hc-wainwright-global-investment-conference [SID1234614638]).

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The on demand presentation will be available, beginning Tuesday, May 24, 2022 at 7:00 a.m. E.T. and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source

On May 16, 2022 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, reported first-quarter 2022 financial results and provided a corporate update (Press release, Ayala Pharmaceuticals, MAY 16, 2022, View Source [SID1234614637]).

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"We continued to execute on advancing our clinical programs during the first quarter of 2022," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "Our highest immediate priority is completing Part A of the RINGSIDE study evaluating AL102 in desmoid tumors and we are on target to announce initial interim data around mid-year. This will be followed by initiation of Part B, the randomized portion of the study, immediately thereafter. We are very encouraged by the positive feedback received from investigators in the study and by early signs of anti-tumor activity. Other important milestones expected this year include clinical updates from the ongoing ACCURACY trial of AL101 in adenoid cystic carcinoma and the planned initiation of a Phase 2 trial of AL102 in T-ALL."

First-quarter 2022 and Recent Business Highlights

Completed enrollment of Part A of the Phase 2/3 RINGSIDE study of AL102 in desmoid tumors: 42 patients have been enrolled in Part A of the RINGSIDE study, which is evaluating the safety and tolerability of AL102, as well as tumor volume by MRI at 16 weeks. Three dosing regimens of AL102 are being tested to determine the optimal dose regimen to advance forward.

Initiated "Window of Opportunity" study of AL101 in adenoid cystic carcinoma (ACC): The study, which is being conducted in collaboration with M.D. Anderson Cancer Center and the Adenoid Cystic Carcinoma (ACC) Research Foundation, is focused on determining the effects of AL101 for the treatment of ACC and other cancers. The goals of the study are to better understand the mechanism of AL101, determine the best treatment regimen and generate data for the future development strategy.
Upcoming Milestones

Initial interim data from pivotal Phase 2/3 RINGSIDE trial in desmoid tumors: Ayala expects to report an initial interim data read-out from Part A of Phase 2/3 RINGSIDE trial of AL102 in desmoid tumors around mid-2022. Part B of the study will be a double-blind placebo-controlled study enrolling up to 156 patients with progressive disease, randomized between AL102 or placebo. The study’s primary endpoint will be progression free survival with secondary endpoints including objective response rates, duration of response and patient reported quality of life measures.
Clinical data from Phase 2 ACCURACY trial of AL101 in ACC: The Phase 2 ACCURACY clinical trial is an open-label, single-arm, multi-center study to assess the clinical activity of AL101 using radiographic assessments of patients with R/M ACC demonstrating disease progression within 6 months prior to dosing. A poster at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting is expected to feature safety, efficacy, pharmacokinetics, and pharmacodynamics data from the 6mg AL101 cohort in the trial.
Initiate Phase 2 clinical trial evaluating AL102 in T-cell acute lymphoblastic leukemia (T-ALL): Ayala plans to begin a Phase 2 clinical trial evaluating AL101 in R/R T-ALL in the second half of 2022.
First-Quarter 2022 Financial Results

Cash Position: Cash and cash equivalents were $27.4 million as of March 31, 2021, as compared to $37.3 million at December 31, 2021.

Collaboration Revenue: Collaboration revenue was $0.4 million for the first quarter of 2022, as compared to $1.0 million for the corresponding quarter in 2021.

R&D Expenses: Research and development expenses were $7.5 million for the first quarter of 2022, compared to $6.9 million for the corresponding quarter in 2021.

G&A Expenses: General and administrative expenses were $2.4 million for the first quarter of 2022, compared to $2.3 million for the first quarter of 2021.

Net Loss: Net loss was $10.0 million for the first quarter ended March 31, 2022, resulting in basic and diluted net loss per share of $0.66. This compares with a net loss of $9.6 million for the first quarter ended March 31, 2021, or basic and diluted net loss per share of $0.74.

For further details on the company’s financial results, refer to form Quarterly Report on Form 10-Q for the three months ended March 31, 2022, filed with the SEC on May 16, 2022.