On August 12, 2021 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported recent business progress and second quarter financial results (Press release, Kronos Bio, AUG 12, 2021, View Source [SID1234586517]).

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"At our virtual R&D Day in May, we outlined our vision for expanding and driving progress in our pipeline of clinical programs that target dysregulated transcription factors and the regulatory networks within cancerous cells. This included unveiling the development strategy for our SYK inhibitor portfolio, which comprises entospletinib (ENTO) and LANRA. These differentiated clinical-stage investigational development candidates have the potential to address the mutations that are present in more than two-thirds of patients with AML," said Norbert Bischofberger, Ph.D., president and CEO. "We are poised to initiate our registrational Phase 3 trial later this year to support potential accelerated approval of ENTO in patients newly diagnosed with NPM1-mutated AML. With the recent FDA clearance of our IND for LANRA in relapsed or refractory FLT-3 mutant AML, we plan to launch our second SYK inhibitor clinical trial in the fourth quarter of 2021, when we also expect to report initial Phase 1 data from our trial of KB-0742, our potent oral, highly selective cyclin dependent kinase 9 inhibitor. I am proud of our Company’s momentum and anticipate multiple important inflection points in the coming months."

Recent Company Highlights

Received clearance from U.S. Food and Drug Administration (FDA) for the IND application of LANRA, a next-generation spleen tyrosine kinase (SYK) inhibitor. The first of two planned Phase 1/2 clinical trials is expected to initiate in Q4 2021 in patients with relapsed or refractor FLT3-mutated AML and will include a dose-escalation and an expansion cohort study design. The first stage will evaluate initial safety, pharmacokinetic (PK) and anti-leukemic activity of escalating once-daily doses of LANRA in combination with gilteritinib. Initial data from this first stage of the trial are anticipated to be available in the second half of 2022.
On track to initiate the Phase 3 trial of ENTO in the second half of 2021 with a pivotal data readout expected in the second half of 2023.
This trial will assess measurable residual disease (MRD) negative complete response (CR) as the primary endpoint to support potential accelerated approval in patients newly diagnosed with NPM1-mutated AML.
Anticipates reporting initial safety, PK and pharmacodynamic (PD) data from Phase 1 trial of KB-0742, a highly selective, orally bioavailable cyclin dependent kinase 9 (CDK9) inhibitor being developed to treat MYC-amplified solid tumors, in the fourth quarter of 2021. The company presented preclinical data for KB-0742 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2021, which showed CDK9 inhibition on an intermittent dosing schedule with KB-0742 resulted in sustained inhibition of tumor growth in multiple types of solid tumors. The findings suggest that genomic amplification of MYC, a well-characterized transcription factor and a long-recognized driver of cancer, is a key factor of sensitivity to CDK9 inhibition.
Hosted a virtual R&D Day in May 2021 to discuss the company’s development strategy for the SYK inhibitors ENTO and LANRA, expectations for the upcoming Phase 1 data readout for KB-0742 and potential populations for expansion cohorts of a Phase 1/2 trial, along with an overview of the company’s differentiated drug discovery platform and future pipeline programs.
Second Quarter Financial Highlights

Cash, Cash Equivalents and Investments: As of June 30, 2021, cash, cash equivalents and investments totaled $419.3 million.

R&D Expenses: Research and development expenses were $19.8 million for the second quarter of 2021, which includes non-cash stock-based compensation expense of $3.4 million.

G&A Expenses: General and administrative expenses were $9.3 million for the second quarter of 2021, which includes non-cash stock-based compensation expense of $3.0 million.

Net Loss: Net loss for the second quarter of 2021 was $29.1 million, or $0.53 per share, including non-cash stock-based compensation expense of $6.4 million.

On August 12, 2021 Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue precision medicines, reported business highlights and financial results for the second quarter, ended June 30, 2021 (Press release, Monte Rosa Therapeutics, AUG 12, 2021, View Source [SID1234586516]).

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"Following our successful initial public offering and with several pivotal additions to our leadership team, we are excited to have the resources in place to advance our pipeline of novel molecular glues towards and into the clinic and to continue the development of our unique and proprietary QuEEN platform. We are delighted by the continuing progress of our pipeline of molecular glue degraders, including the recent transition of our NEK7 program into lead optimization," said Markus Warmuth, M.D., CEO of Monte Rosa. "As we look ahead for the year, we remain on track to progress a development candidate for our lead program targeting GSPT1 into IND-enabling studies. We also expect to advance at least one additional program into lead optimization this year. All of this will bring us closer to our goal of tackling the previously undruggable or inadequately drugged target protein universe and fostering a new generation of precision medicine therapeutics."

SECOND QUARTER 2021 & RECENT HIGHLIGHTS

Completed upsized $255.6 million initial public offering: Monte Rosa Therapeutics closed its initial public offering of 13,455,000 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,755,000 additional shares of common stock at the public offering price of $19.00 per share. The aggregate gross proceeds were approximately $255.6 million before deducting underwriting discounts and commissions and other offering expenses.
Advanced NEK7 program into lead optimization: NEK7 is an activator of the NLRP3 inflammasome, a central regulator of cellular inflammatory responses to pathogens, damage and stress. Aberrant NLRP3 inflammasome activation is implicated in the pathogenesis of multiple autoimmune diseases. Our NEK7 degrader program has progressed into lead optimization, with the next major milestone anticipated to be selection of a development candidate.
Strengthened leadership team with key appointments: Since the start of 2021, Monte Rosa Therapeutics has made several key appointments aimed at further supporting advancement of its platform, expanding its business operations and preparing to bring its molecular glue degrader therapies into clinical trials. Most recently, the company announced the appointment of Filip Janku, M.D., Ph.D., as Chief Medical Officer, and has named Phil Nickson, Ph.D., J.D., as Head of Legal Operations and Jennifer Champoux as Vice President of Operations.
Expanded global presence: The company has opened two new state-of-the-art research centers in the Seaport District of Boston and in Basel, Switzerland. These sites will continue to enable the recruitment of key talent in both the U.S. and Europe.
KEY UPCOMING MILESTONES + EVENTS

Development candidate selection for lead program targeting GSPT1 for the treatment of cancers overexpressing one of the Myc family genes (c-Myc, N-Myc and L-Myc). The company anticipates selecting a development candidate and advancing it into IND-enabling studies before year-end.
Progression of at least one program in addition to NEK7 into lead optimization by end of 2021.
Upcoming conferences and presentations:
Owen Wallace, Ph.D., Chief Scientific Officer, to present at the European Protein Degradation Conference at 14:10 CEST, Sept. 21, in a session titled, "Facilitating interactions between ubiquitin ligase and selected proteins through rational design of molecular glues."
Sharon Townson, Ph.D., Chief Technology Officer, to present an overview of the company’s QuEEN platform at the 4th Annual Targeted Protein Degradation Summit at 11:45 a.m. EDT, Oct. 27; will also participate in a panel discussion titled, "What’s Next on the Horizon for Targeted Protein Degradation?" at 5 p.m. EDT, Oct. 28.
John Castle, Chief Data Scientist, to present an overview of the company’s QuEEN platform at the Genomics Live and BioData World Congress at 15:40 CEST, Nov. 3.
SECOND QUARTER 2021 FINANCIAL RESULTS

Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2021 were $14.6 million, compared to $4.9 million for the second quarter of 2020. The increase in R&D expense was primarily due to the expansion of research and development activities in the United States and Switzerland including increased headcount and facilities, as well as corresponding increases in laboratory related expenses.

General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2021 were $3.5 million, compared to $0.5 million for the second quarter of 2020. The increase in G&A expense was a result of increased headcount and expenses in support of the company’s growth.

Net Loss: Net loss for the second quarter of 2021 was $18.4 million, compared to $5.4 million for the second quarter of 2020.

Cash Position and Financial Guidance: Cash and cash equivalents as of June 30, 2021, were $357.1 million, compared to $41.7 million as of December 31, 2020. The June 30th balance does not include the additional $31.0 million in net proceeds the company received as part of its initial public offering from the full exercise of the underwriters’ option to purchase up to an additional 1,755,000 shares of common stock at the public offering price of $19.00 per share. The company expects its cash and cash equivalents , including the aggregate net proceeds from the initial public offering, will be sufficient to fund our planned operations and capital expenditures into late 2024.

On August 12, 2021 Adagene Inc. ("Adagene" or the "Company") (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, reported appointment of an interim Chief Medical Officer and new members of its Scientific and Strategic Advisory Board (the "SAB") (Press release, Adagene, AUG 12, 2021, View Source [SID1234586515]). The appointments include pioneers in the immuno-oncology field: Steven Fischkoff, M.D., Stanley Frankel, M.D., FACP and Robert Spiegel, M.D., FACP.

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"We are honored to have such a prestigious group with deep therapeutics development experience to join our efforts in bringing transformative new cancer therapeutics to patients worldwide," said Peter Luo, Ph.D., Co-Founder, Chief Executive Officer and Chairman of the Board of Adagene. "This team has spearheaded some of the original immunotherapies, and their strategic vision adds tremendous value to Adagene as we design global development programs to maximize the potential of our robust pipeline. We are fortunate to work with these talented individuals in leveraging our innovative antibody-based technology platforms to usher in the next generation of immuno-oncology treatments."

The new appointments include:

Steven Fischkoff, M.D. – Dr. Fischkoff serves as the interim Chief Medical Officer of Adagene and is a member of the company’s SAB. He is a board-certified medical oncologist who has been active in the pharmaceutical industry for approximately 30 years. Previously, while at Medarex, Dr. Fischkoff led the clinical development of Yervoy (ipilimumab), the first checkpoint inhibitor and the only anti-CTLA-4 product approved by the U.S. Food and Drug Administration ("FDA"). He also led development of Humira (adalimumab), the world’s top selling pharmaceutical product, from first-in-man through submission and approval in the U.S. and the EU at Knoll Pharmaceuticals and Abbott Laboratories.

Stanley Frankel, M.D., FACP – Dr. Frankel joins the SAB as a hematologist-oncologist with over 20 years of industry experience, including the research, clinical development, and commercialization of immuno-oncology and cellular therapies. He served as Corporate Vice-President Immuno-Oncology at Celgene where he oversaw the clinical development collaborations for the Medimmune/AstraZeneca alliance for durvalumab, and Celgene’s alliances with BeiGene for tislelizumab and with Juno Therapeutics to develop cell-based therapies. He served as Senior Vice-President, Global Drug Development for Cell Therapy at BMS following the acquisition of Celgene to oversee the filing and development of Breyanzi (lisocabtagene maraleucel) and Abecma (idecabtagene vicleucel). Previously, he oversaw T-cell engager bispecific antibody development as Vice President, Clinical Development at Micromet including development of Blincyto (blinatumomab). He is Chief Medical Officer at Cytovia Therapeutics and is a Non-Executive Director at Precision Biosciences. He serves on the Scientific Advisory Board at Sutro Biopharma, Immunai, and Minerva Biotechnologies. Dr. Frankel is also an Adjunct Associate Professor of Medicine at the Vagelos College of Physicians and Surgeons at Columbia University, New York.

Robert Spiegel, M.D., FACP – Dr. Spiegel joins the SAB with over 30 years of extensive R&D and operational experience in biopharmaceuticals and as an advisor to venture capital and private equity firms. Following a fellowship at the National Institutes of Health in medical oncology, Dr. Spiegel was the Director of Translational Medicine at NYU Cancer Center and then spent over 25 years at Schering-Plough (now Merck & Co.) where he joined as the first Director for Oncology Clinical Research, and subsequently held a series of senior executive positions, including Chief Medical Officer. He led the development of Temodar (temozolomide) and Remicade (infliximab) and was involved with approval of over 30 New Drug Applications by the FDA. Dr. Spiegel has been a consultant to the biotech industry and has served on the scientific advisory board and board of directors of multiple biotech companies.
Adagene’s SAB is comprised of leaders who have played a key role in the field of immuno-oncology.

The SAB will work cohesively with management and other key advisors to provide strategic input as the company pursues global clinical development of its transformative, expanding pipeline.

On August 12, 2021 Vaccitech plc (NASDAQ: VACC) reported its financial results for the second quarter, ended June 30, 2021, and provided an overview of the Company’s recent corporate developments (Press release, Vaccitech, AUG 12, 2021, View Source [SID1234586514]). Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer.

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"The second quarter of 2021 was our first as a public company following our initial public offering that closed in May," said Bill Enright, CEO of Vaccitech. "Capital raised by that transaction as well as from a Series B private round earlier this year is being applied to our chronic infectious disease and oncology programs. We continue to make significant progress across all of our ongoing programs, including the recent announcement of our clinical collaboration with Arbutus."

Second Quarter and Recent Corporate Developments

Closed an initial public offering of American Depository Shares for total gross proceeds of $110.5 million.
Signed a clinical trial collaboration agreement with Arbutus Biopharma Corporation to evaluate an innovative therapeutic combination for the treatment of subjects with chronic hepatitis B virus (HBV) infection (CHB) who are already receiving standard-of-care nucleoside or nucleotide analog (NA) therapy. The Phase 2a clinical trial will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of Arbutus’s RNAi therapeutic, AB-729, followed by the Company’s immunotherapy candidate, VTP-300, in NA-suppressed subjects with CHB.
Upcoming Milestones

In the fourth quarter of 2021, the Company expects to announce topline safety and immunogenicity data from the Phase 1 trial of VTP-300, HBV001, in healthy volunteers and patients with chronic HBV infection.
In the same quarter, the Company expects to initiate dosing in the Phase 1/2a trial of VTP-600 in patients with non-small cell lung cancer in combination with a checkpoint inhibitor and chemotherapy.
In the first quarter of 2022, the Company intends to conduct an interim efficacy review, of HBV002, the Phase 1/2a clinical trial of VTP-300 in patients with chronic HBV infection.
In the second quarter of 2022, the Company intends to conduct an interim efficacy review of HPV001, the Phase 1/2a clinical trial of VTP-200 in patients with high-risk and persistent HPV infection.
Second Quarter 2021 Financial Highlights:

Cash position: As of June 30, 2021, cash and cash equivalents were $243.6 million, compared to $43.3 million as of December 31, 2021. The increase was primarily due to completion of the Series B financing in the first quarter of 2021, which raised a further $125.3 million, and to the initial public offering in the second quarter, which raised gross proceeds of $110.5 million. The Company believes its cash and cash equivalents are sufficient to fund operations into the first half of 2024.
Research and development (R&D) expenses: Research and development expenses were $4.5 million for the second quarter of 2021 compared to $3.9 million for the comparable period of the prior year. The increase in R&D expenses was primarily due to increased spending on progressing the development of VTP-300 and VTP-850.
General and administrative expenses: General and administrative expenses were $12.4 million for the second quarter of 2021 compared to $1.0 million for the comparable period of the prior year. The increase was primarily attributable to higher personnel costs, reflecting mainly an increase in the Company’s headcount over the prior period and vesting of certain share awards upon IPO, and higher insurance costs associated with operating as a public company.
Net loss: The Company generated a net loss attributable to shareholders of $15.9 million, or $0.64 per share on both basic and fully diluted bases, for the second quarter of 2021 compared to a net loss of $3.6 million, or $0.45 per share on both basic and fully diluted bases, for the same period of the prior year.

On August 12, 2021 Century Therapeutics, (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported financial results and business highlights for the second quarter ended June 30, 2021 (Press release, Century Therapeutics, AUG 12, 2021, View Source [SID1234586513]).

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"With the proceeds raised from our IPO in June, we are well positioned to advance our lead candidate CNTY-101 toward clinical development, targeting IND filing in mid-2022," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "We continue our investment in our iPSC platforms and are pleased with the progress achieved in developing iPSC-derived cell product candidates for the treatment of cancers with high unmet clinical need. We look forward to providing scientific updates on our programs and platform in the second half of 2021."

Recent Highlights

Raised $221 million in public offering of common stock: In June 2021, the company announced a public offering of 10,550,000 shares of its common stock at a price of $20 per share. The underwriters also exercised their option to purchase an additional 1,582,500 shares of common stock for total offering net proceeds of $221 million.
Expanded our Board of Directors: The Company appointed pharmaceutical industry veterans Alessandro Riva, M.D. and Kimberly Blackwell, M.D., as new Independent Directors.
Continued manufacturing and technical operations investment: Our US manufacturing facility is expected to be operational by end of 2021.
Second Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $440.0 million as of June 30, 2021, as compared to $246.1 million as of March 31, 2021. This includes $221.2 million in net proceeds from the company’s public offering in June 2021.

Research and Development (R&D) expenses: R&D expenses were $18.9 million for the three months ended June 30, 2021, compared to $8.5 million for the same period in 2020.

General and Administrative (G&A) expenses: G&A expenses were $4.1 million for the three months ended June 30, 2021, compared to $2.3 million for the same period in 2020.
Net loss: Net loss was $23.3 million for the three months ended June 30, 2021, compared to $15.3 million for the same period in 2020.