On February 24, 2022 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer and other serious diseases, reported recent business progress and fourth-quarter and full-year 2021 financial results (Press release, Kronos Bio, FEB 24, 2022, View Source [SID1234608972]).

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"We had a successful year, marked by the significant progress we made across our clinical pipeline, including initiating our registrational Phase 3 AGILITY study of entospletinib, and initiating our Phase 1/2 study of KB-0742 and subsequently reporting positive initial results from the KB-0742 study," said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. "We expect to announce the initiation of our third clinical trial later this quarter. We continue to dose-escalate KB-0742 and anticipate reaching the recommended Phase 2 dose and sharing additional Phase 1 data in the fourth quarter."
KB-0742 Update
•Kronos Bio is continuing to enroll patients in the Phase 1/2 trial of KB-0742. KB-0742 is the company’s internally discovered, highly selective, orally administered cyclin dependent kinase 9 (CDK9) inhibitor being developed to treat MYC-amplified and other transcriptionally addicted solid tumors. Kronos Bio reported positive initial data from the study last year and is continuing to dose escalate.
•The company expects to announce a recommended Phase 2 dose and announce updated Phase 1 data in Q4 2022.
•While the first stage of the study does not mandate enrollment of patients with MYC amplification or other evidence of transcriptional addiction, as the trial nears pharmacologically active dose levels, the company anticipates increased enrollment of patients who may be more likely to respond to CDK9 inhibition.
SYK Inhibitor Program Update
•Kronos Bio expects to dose the first patient in a Phase 1b/2 clinical trial of lanraplenib in the first quarter of 2022. This trial will evaluate lanraplenib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML) in combination with the current standard of care, gilteritinib.
•To better focus on and prioritize the company’s resources on the areas of highest unmet need, Kronos Bio has decided not to proceed at this time with its previously planned second Phase 1b/2 clinical trial of lanraplenib in combination with venetoclax/azacitidine.
Fourth-Quarter Company Highlights
•Kronos Bio dosed the first patient in the registrational Phase 3 AGILITY clinical trial of entospletinib, a selective inhibitor targeting spleen tyrosine kinase (SYK), in combination with standard of care anthracycline and cytarabine (7+3) chemotherapy. This trial is the first in AML to

Exhibit 99.1
use measurable residual disease (MRD) as the primary endpoint and has the potential to support accelerated approval of entospletinib by the U.S. Food and Drug Administration as a treatment for patients newly diagnosed with NPM1-mutated AML who are fit for intensive induction. The company expects to share data from the trial in the second half of 2023.
•Kronos Bio announced positive data from the ongoing Phase 1/2 clinical trial of KB-0742. The initial analysis of the ongoing dose escalation stage of the trial demonstrated a differentiated pharmacokinetic profile and evidence of target engagement for KB-0742.
•Kronos Bio appointed Roshawn Blunt to its Board of Directors. Ms. Blunt has decades of experience in the commercialization of new therapeutics, including oncology medicines, with expertise in patient access, reimbursement and health policy. Her expertise will be highly relevant as Kronos Bio advances its lead programs.
•Kronos Bio announced its multi-year collaboration with Tempus Labs, Inc., a leader in artificial intelligence and precision medicine, during the fourth quarter. The agreement provides Kronos Bio with access to real-world patient genomic and transcriptomic data and data analytics tools, with the goal of accelerating the development of the company’s current and future clinical portfolio.
Fourth-Quarter and Full-Year 2021 Financial Highlights
•Cash, Cash Equivalents and Investments: With its ongoing and currently planned clinical programs and $339.5 million in cash, cash equivalents and investments as of December 31, 2021, the company anticipates sufficient resources to fund its planned operations into the second half of 2024.

•R&D Expenses: Research and development expenses were $50.8 million for the fourth quarter of 2021, which includes non-cash stock-based compensation expense of $3.4 million. For the full year of 2021, research and development expenses were $112.9 million, which includes non-cash stock-based compensation expense of $13.0 million.

Research and development expenses for the fourth quarter included the $29.0 million milestone paid to Gilead Sciences upon initiation of Kronos Bio’s registrational Phase 3 clinical trial of entospletinib in December 2021.

•G&A Expenses: General and administrative expenses were $11.6 million for the fourth quarter of 2021, which includes non-cash stock-based compensation expense of $4.0 million. For the full year of 2021, general and administrative expenses were $38.5 million, which includes non-cash stock-based compensation expense of $13.3 million.

•Net Loss: Net loss for the fourth quarter of 2021 was $62.3 million, or $1.13 per share, including non-cash stock-based compensation of $7.4 million. Net loss for the full-year 2021 was $151.1 million, or $2.76 per share, including non-cash stock-based compensation expense of $26.2 million.

On February 24, 2022 A Columbus pharmaceutical reported that has raised $40 million toward a drug that could slow progression of a type of treatment-resistant metastatic breast cancer – all because a grad student at Duke University five years ago happened to grab a vial of the once-abandoned osteoporosis treatment (Press release, Sermonix Pharmaceuticals, FEB 24, 2022, View Source [SID1234608988]).

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Sermonix Pharmaceuticals Inc. is awaiting data from more than 100 patients treated over the past two years. If results show significant benefit, the company could seek a meeting this summer with the U.S. Food and Drug Administration to map out next steps, COO Dr. Miriam Portman said.

The company licensed the drug lasofoxifene in 2015 to renew efforts toward approval as an osteoporosis treatment, but quickly changed purpose when Duke identified potential in breast cancer. That use has since shown promising results in mice. The FDA granted fast-track status to the study in 2019.

"It was really an ‘aha moment’ and a huge pivot point for us," said Dr. David Portman, Sermonix CEO. "The company is confident in the activity of the drug, and is hopeful to get breakthrough designation and get the drug to availability to patients in the coming years."

Perceptive Xontogeny Ventures led the Series A3 round in November with some repeat investors. Perceptive partners Fred Callori and Ben Askew joined the Sermonix board. The company previously raised seed funding and a $20 million round in 2019.

Sermonix plans to open a downtown office this spring, and some Philadelphia-area executives with pharmaceutical industry experience plan to move, David Portman said. The funding will help it wrap up the two clinical trials, pursue regulatory approval and increase manufacturing of both the drug and a companion diagnostic test for the type of cancer it targets.

The Portmans, physicians who are married and live in Bexley, founded Columbus Center for Women’s Health Research in 1997 to conduct clinical studies on hormone therapy, osteoporosis, contraception and heart disease. It was acquired by another Columbus research business in 2015. They formed Sermonix and licensed lasofoxifene from Ligand Pharmaceuticals Inc.

San Diego-based Ligand developed the drug in a collaboration with Pfizer Inc. in the 1990s. The hormonal therapy is a selective estrogen receptor modulator (or SERM, hence Sermonix) – basically fooling estrogen receptors to slow diseases stimulated by the hormone. But attempts at FDA approval hit a road block in 2009, and Pfizer went with a different compound. Rights later reverted to Ligand.

Sermonix’s license entitles Ligand to as much as $45 million in milestone payments and 6% to 10% royalties on any eventual sales, according to regulatory filings.

Meanwhile, Donald McDonnell, who was on the inventing team at Ligand before moving to Duke, had become co‐director of Duke Cancer Institute’s program in women’s cancer.

Treatments that inhibit the production or uptake of estrogen are effective against types of breast tumors stimulated by the hormone – but those tumors often mutate to resist the therapy.

Researchers in McDonnell’s lab in 2016 were studying a specific mutation that’s diagnosed in about 20,000 patients a year. A graduate student was working with ovarian tumor cells with the same mutation, and started testing every known hormonal treatment on them, according to the institute’s website.

Lasofoxifene – on hand only because of McDonnell’s Ligand work – was the only one that slowed growth.

"He had some of that compound on his shelf," David Portman said. "It showed very unexpected activity. It was a fortunate series of events."

Duke patented the application for breast cancer, and started working with Sermonix, the license-holder, toward commercialization. The company has a video explaining how it works.

"That was a significant unmet medical need and a far greater medical benefit to patients than what we were currently working on," David Portman said.

Because of the earlier osteoporosis studies, the drug could skip over the first phase showing it’s safe for use in humans. Two trials are wrapping up comparing the current standard of care for treatment-resistant cancer against lasofoxifene; one uses it alone and the other in combination with a second drug.

Breast cancer with this mutation is incurable once at this stage, but the therapy aims to slow progression and spread, making it a manageable chronic condition.

Perceptive Xontogeny, a joint fund of New York City and Boston firms, also was the lead investor in the $40 million 2020 round that launched Grove City gene therapy startup Forge Biologics Inc., part of a fast-growing Central Ohio biotech sector.

"It felt very lonely for a while, and now it’s started to grow significantly," David Portman said. "It is becoming an exciting hub."

On February 24, 2022 Novocure (NASDAQ: NVCR) reported that a new study published in the Journal of Clinical Investigation (JCI) finds treatment with Tumor Treating Fields (TTFields) mediated cell disruption activates the immune system and triggers an anti-tumor cell response that may be effectively used together with existing immunotherapy approaches in the treatment of solid tumors, with limited systemic toxicity (Press release, NovoCure, FEB 24, 2022, View Source [SID1234609006]).

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"TTFields’ ability to activate a downstream immune response, effectively turning a cold tumor hot, is a unique element of TTFields therapy," said Uri Weinberg, Novocure’s Chief Science Officer. "Given the depth of clinical research focused on the use of immunotherapies and the broad applicability of TTFields, this could be critical to the treatment path for solid tumor cancers."

Preclinical research has shown evidence that TTFields may induce a pro-inflammatory and broader immunological effect on tumor cells. This study outlines translational research by Dr. Dongjiang Chen and colleagues from the David Tran Laboratory of Quantitative Cancer Research at the University of Florida. Preclinical data demonstrated that treatment with TTFields directly disrupted the nuclear envelope of glioblastoma (GBM) tumor cells. This led to leakage of DNA that activates the cGAS/STING and AIM2 signaling pathways, driving early anti-tumor immune responses. Further, a genetic signature was identified in patients treated with TTFields therapy indicating an acquired immune response. Collectively, these novel preclinical and patient data further elucidate the downstream cellular processes resulting from TTFields’ mechanism of action that support the potential for a therapeutic advantage when used together with immunotherapy, with limited systemic toxicity.

Based on these findings, Dr. David Tran, Chief of the Division of Neuro-Oncology, at the McKnight Brain Institute at the University of Florida, designed the phase 2 pilot 2-THE-TOP clinical study, evaluating the use of TTFields therapy together with the anti-PD-1 therapy (pembrolizumab) and chemotherapy (temozolomide) for the treatment of newly diagnosed GBM in 25 patients. In November 2021, updated data from the ongoing 2-THE-TOP study was presented at the Society for Neuro-Oncology (SNO) 2021 Annual Meeting. These preliminary data showed 19 patients with greater than 9 months of follow-up displayed a median progression-free survival (primary endpoint) of at least 11.2 months. Additionally, 193,760 peripheral blood mononuclear cells were sequenced in 12 patients before pembrolizumab was administered and detected robust post-TTFields T cell activation in 11 of 12 patients via the T1IFN trajectory with a strong correlation with the TCRαβ clonal expansion Simpson index (Spearman coefficient r=-0.8, P=0.014). This finding is in line with the JCI publication, and contributes to the building body of evidence suggesting TTFields’ mechanism of action induces a downstream signaling pathway that initiates an active immune response that aids the body’s ability to fight cancer cells.

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 22,000 patients have been treated with TTFields therapy.

On February 24, 2022 Portage Biotech Inc. (NASDAQ: PRTG) ("Portage" or the "Company"), a clinical-stage immuno-oncology company developing therapies to improve patient lives and increase survival by avoiding and overcoming cancer treatment resistance, reported financial results for the quarter ended December 31, 2021 (the "third quarter") (Press release, Portage Biotech, FEB 24, 2022, View Source [SID1234609033]).

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"During the third quarter and in recent weeks we’ve taken steps to accelerate our lead programs for PORT-2 and PORT-3, investigating options to expand our clinical sites beyond our current footprint and finding the means of accelerating patient enrollment," said Dr. Ian Walters, chief executive officer of Portage. "With our enhanced management team, efficient organization, and financial resources obtained in 2021, we are well positioned to execute our unique drug development strategy to deliver on important clinical milestones over the next two years."

Business Update

Enhanced the management team with the appointments of Brian Wiley as Chief Business Officer, Joseph Ciavarella as Chief Accounting Officer; expanded the Board of Directors with the addition of Jim Mellon, Linda Kozick, and Mark Simon.
Enrollment continues in the Company’s IMP-MEL randomized Phase 1/2 study of PORT-2 and its PRECIOUS Phase 1 study of PORT-3 in patients with NY-ESO-1 expressing tumors.
The Company plans to issue a Research & Development update in March 2022 which will include preliminary safety data on its PORT-2 and PORT-3 programs as well as other details from its clinical development plan.
Presented at high-profile investor conferences:
Management participated in January 2022 investor conferences including the LifeSci Advisors Corporate Access Event, H.C. Wainwright BioConnect Conference, and the B. Riley Securities’ Oncology Investor Conference.
Hosted Key Opinion Webinar How iNKT Agonists Could Improve Immuno-Oncology Treatment with leading researchers from La Jolla Institute of Immunology and Imperial College London. Replay available here.
Third Quarter FY 2022 Financial Results

The Company generated a net loss and comprehensive loss of approximately $4.2 million in the three months ended December 31, 2021 ("Fiscal 2022 Quarter"), compared to a net loss and comprehensive loss of approximately $1.3 million in the three months ended December 31, 2020 ("Fiscal 2021 Quarter"), an increase in loss of $2.9 million year over year. Operating expenses, which include research and development and general and administrative expenses, were approximately $4.2 million in the Fiscal 2022 Quarter, compared to $0.9 million in the Fiscal 2021 Quarter, an increase of $3.3 million, which is discussed more fully below.

The Company’s other items of income and expense were substantially non-cash in nature and were approximately $0.1 million net income in the Fiscal 2022 Quarter, compared to approximately $0.5 million net loss in the Fiscal 2021 Quarter, a change in other items of income and expense of approximately $0.6 million, year over year. The primary reasons for the year over year difference in other items of income and expense was the change of $0.8 million in the fair value of the warrants issued with respect to the SalvaRx note settlement, which was partially offset by the year over year increase in the loss from an associate accounted for under the equity method of $0.1 million and the income on equity issued at a discount of $0.1 million in the Fiscal 2021 Quarter, representing the difference between the market price and the contractual exercise price, relating to the settlement of the SalvaRx notes and warrants.

Research & development ("R&D") costs increased by approximately $1.5 million, from approximately $0.4 million during the Fiscal 2021 Quarter, to approximately $1.9 million during the Fiscal 2022 Quarter. The increase was primarily attributable to non-cash share-based compensation expense associated with grants made under the 2021 Equity Incentive Plan of $1.0 million and salaries and bonuses of $0.7 million to directors and senior management. Additionally, the Fiscal 2021 Quarter was impacted by a general slow down in expenditures resulting from the pandemic.

General and administrative ("G&A") expenses increased by approximately $1.8 million, from approximately $0.4 million during the Fiscal 2021 Quarter, to approximately $2.2 million during the Fiscal 2022 Quarter. The principal reason for the increase in the Fiscal 2022 Quarter was the $1.1 million of non-cash share-based compensation expense associated with the Company’s 2021 Equity Incentive Plan, of which $0.7 million is associated with Directors’ compensation, and $0.4 million is associated with management compensation. No share-based compensation expense under the 2021 Equity Incentive Plan was incurred during the Fiscal 2021 Quarter. Additionally, the Company incurred an increase of $0.4 million in professional fees relating to initiatives associated with a corporate restructuring and public relations / business development. Finally, D&O insurance premiums increased $0.4 million in the current year period due to market rate increases in the cost of coverage.

Additionally, the Company reflected a net income tax expense of approximately $0.1 million in the Fiscal 2022 Quarter, compared to a net income tax benefit of approximately $0.1 million in the Fiscal 2021 Quarter. The Fiscal 2022 Quarter reflects the change in the foreign currency exchange rate on deferred tax liability settleable in British pounds sterling and the Fiscal 2021 Quarter reflected recoverable research and development tax credits generated in the U.K.

As of December 31, 2021, the Company had cash and cash equivalents of approximately $25.6 million and total current liabilities of approximately $0.6 million (inclusive of approximately $0.2 million warrant liability settleable on a non-cash basis). For the nine months ended December 31, 2021, the Company is reporting a net loss of approximately $10.3 million and cash used in operating activities of approximately $4.5 million. As of January 31, 2022, the Company had approximately $25.1 million of cash on hand to enable achieving important clinical milestones over the next two years.

On February 24, 2022 EVERSANA reported that it will be attending Reuters Events: Pharma USA 2022 on March 16th & 17th in Philadelphia (Press release, EVERSANA, FEB 24, 2022, View Source [SID1234609061]). Krista Pinto, President, Deployment Solutions, will participate with industry leaders in a panel discussion covering the importance of salesforce instances keeping pace with rapidly evolving HCP preferences March 17th at 12:20 PM EST . Key topics include:

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With a shift in HCP preferences, expectations and a hybrid future, learn how to maximize your salesforce outputs by shifting the way your organization sets KPI’s as well as the metrics used to read them
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Confirmed speakers:

Krista Pinto, President, Deployment Solutions, EVERSANA
Dion Warren, VP, Head of U.S. Oncology Business Unit, Takeda
Frank Armenante, Director, Commercial Execution, Novo Nordisk
Tatiana Yglesias, Head of Migraine Marketing, Neuroscience, Novartis
Nithya Srinivasan, Director of Marketing, Rheumatology, Janssen
Pharma USA unites North America’s visionary pharma changemakers, leading solution providers, patient experts and industry heavyweights — from commercial, marketing, medical affairs, patient engagement, market access and RWE — who’ll unlock unrestrained innovation and drastically improved health outcomes.