On November 7, 2022 Repertoire Immune Medicines reported that Torben Straight Nissen has been appointed as interim Chief Executive Officer, succeeding John Cox, who will continue with the company in an advisory role (Press release, Repertoire, NOV 7, 2022, View Source;utm_source=dlvr.it&utm_medium=twitter [SID1234623241]). With more than two decades of leadership experience, Straight Nissen joins the company as it shifts its resources and operations to focus primarily on unlocking the potential of Repertoire’s DECODE Platform to develop transformative immune medicines against novel immune targets in cancer, autoimmune disorders, and infectious disease.

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"I want to thank John for his leadership and vision for harnessing the potential of the immune repertoire to develop new medicines," said Doug Cole, M.D., Chairman, Repertoire and Managing Partner, Flagship Pioneering. "As the first CEO of Repertoire, John established the company to deliver novel immune medicines to patients, and we will continue to build upon this bold ambition."

Cole continued, "We welcome Torben as the next CEO of Repertoire. His significant experience leading and shaping platform-based biotech companies makes him well-positioned to drive Repertoire forward toward unlocking the potential of its DECODE platform."

"Repertoire has applied its proprietary DECODE platform to develop an unprecedented and unique understanding of the immune synapse. I am energized by the opportunity to leverage Repertoire’s powerful platform to develop novel and highly selective immune-based medicines for the treatment of cancer, autoimmune disorders, and infectious disease," said Straight Nissen. "I look forward to working with Repertoire’s impressive team to provide new and important therapies for patients with these diseases."

"The mission of Repertoire is to discover the immune codes that drive cellular immunity and to use those codes to create new immune medicines," said Cox. "Our recent discoveries of novel epitopes and T cell receptors in cancer and autoimmune diseases demonstrate the promise of the platform that we built. I am grateful to each member of the Repertoire team for making these advancements possible, and to the leadership team that built this company. I look forward to seeing Repertoire continue its mission to create a new class of immune medicines under Torben’s leadership."

About Torben Straight Nissen

Torben Straight Nissen is a senior partner at Flagship Pioneering, contributing to Flagship’s strategic and operational objectives, including the origination of new Flagship Labs companies. He is an experienced biotech entrepreneur and has been a member of Flagship’s ecosystem since first joining as President of Rubius Therapeutics in 2016. Prior to joining Flagship, Straight Nissen was at Pfizer where he led Strategic Portfolio Management for the company’s worldwide R&D organization and oversaw a portfolio spanning from discovery to Phase 2 across all major therapeutic areas. He has held leadership positions in multiple biotech companies, including Ascendis Pharma and Maxygen. Straight Nissen currently serves on the board of Axcella Health and is the founding CEO of FL84. He is also a co-author or co-inventor of over 100 publications and published patents.

Company Update

In October, the company stopped Phase 1 clinical studies of its autologous multi-targeted T cell therapeutic candidates, RPTR-147 and RPTR-168 in human papillomavirus (HPV) positive tumors. This followed an assessment of recent data which showed that while stable disease was observed in a small group of patients, this effect was limited and does not support advancing these programs.

The company plans to apply the translational insights from these studies to inform its ongoing development of novel treatments for solid tumors. These changes reposition the company as a pre-clinical organization with reduced operational needs, and as a result, the company reduced its staff earlier this month.

Going forward, Repertoire will focus on unlocking the potential of its proprietary DECODE platform to develop transformative medicines against novel immune targets in cancer, autoimmune disorders and infectious disease.

About the DECODE Platform

The DECODE platform is a powerful discovery engine that characterizes essential elements of the immune synapse. In particular, the platform identifies T cell receptor-antigen pairs in the context of other important features of the immune synapse, such as T cell function and how antigens are presented by molecules on antigen-presenting cells, known as major human leukocyte antigen, or HLA, molecules. Repertoire intends to utilize these insights into key drivers that govern immune function to design and develop novel immune product candidates.

On November 7, 2022 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the third quarter 2022 and provided an update on the company’s recent developments (Press release, FibroGen, NOV 7, 2022, View Source [SID1234623240]).

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"I am very pleased with our progress across our clinical development programs with 3 pivotal trials expected to read out for pamrevlumab in 2023 and two more in 2024. Notably, our Phase 3 trials of roxadustat in the U.S. and Europe for anemia of myelodysplastic syndromes, and chemotherapy-induced anemia in China add two more pivotal readouts next year," said Enrique Conterno, Chief Executive Officer, FibroGen. "The strategic financing transaction with NovaQuest provides additional non-dilutive capital which strengthens our balance sheet to support the development and commercialization of pamrevlumab while continuing to advance and expand our pipeline."

Recent Developments:

Announced non-dilutive royalty monetization transaction with NovaQuest Capital Management secured by 22.5% of roxadustat royalty revenue in the territories licensed to Astellas Pharma Inc., providing $50 million to support our strategic priorities.
Completed enrollment of the MATTERHORN Phase 3 study of roxadustat in patients with anemia of myelodysplastic syndromes (MDS).
Roxadustat continues to gain approvals in additional countries around the world. It is now approved in China, Europe, Japan, and numerous other territories for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis.
China Performance:

FibroGen’s net product revenue under U.S. GAAP from the sale of roxadustat in China was $17.4 million compared to $13.4 million in the third quarter of 2021, an increase of 29%.
Third quarter total roxadustat net sales in China1 by FibroGen and the distribution entity (JDE) jointly owned by FibroGen, and AstraZeneca was $59.0 million, compared to $57.8 million in the third quarter of 2021.
Roxadustat continues to be the number one brand based on value share in the anemia of CKD market in China.
Upcoming Milestones:

Pamrevlumab

Topline data from the LELANTOS-1 Phase 3 study of pamrevlumab in non-ambulatory DMD patients expected 1H 2023.
Topline data from the ZEPHYRUS-1 Phase 3 study of pamrevlumab in IPF expected mid-2023.
Topline data from the LELANTOS-2 Phase 3 study of pamrevlumab in ambulatory DMD patients expected 2H 2023.
Topline data from the LAPIS Phase 3 study of pamrevlumab in LAPC expected 1H 2024.
Topline data from the ZEPHYRUS-2 Phase 3 study of pamrevlumab in IPF expected mid-2024.
Roxadustat

Topline data from the MATTERHORN Phase 3 study of roxadustat in anemia of MDS expected 1H 2023.
Topline data from the China Phase 3 study of roxadustat for the treatment of chemotherapy-induced anemia (CIA) expected mid-2023.
Financial:

Total revenue for the third quarter of 2022 was $15.7 million, as compared to $156.0 million for the third quarter of 2021, which included $120 million of milestone payments from Astellas related to the EU approval of roxadustat.
Net loss for the third quarter of 2022 was $91.7 million, or $0.98 net loss per basic and diluted share, compared to a net income of $49.8 million, or $0.54 net income per basic and diluted share one year ago.
At September 30, 2022, FibroGen had $441.6 million in cash – defined as cash, cash equivalents, investments, and accounts receivable.
Today we announced a non-dilutive royalty monetization transaction with NovaQuest Capital Management, providing $50 million to support our strategic priorities.
After this transaction and based on our latest forecast, we anticipate our 2022 ending cash balance to be $380-$410 million.
_________________________

1 Total roxadustat net sales in China includes sales made by the distribution entity as well as FibroGen China’s direct sales, each to its own distributors. The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen’s financial statements.

Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Monday, November 7, 2022, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the Company’s website, www.fibrogen.com. To access the call by phone, please go to this link (registration link), and you will be provided with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. A replay of the webcast will also be available for a limited time at the following link (webcast replay).

About Pamrevlumab
Pamrevlumab is a potential first-in-class antibody being developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD), and in Phase 2/3 for the treatment of metastatic pancreatic cancer. The U.S. Food and Drug Administration has granted Orphan Drug Designation (ODD), and Fast Track designation to pamrevlumab for the treatment of patients with IPF, DMD, and LAPC. The U.S. Food and Drug Administration has also granted Rare Pediatric Disease Designation to pamrevlumab for the treatment of patients with DMD. Pamrevlumab has demonstrated a safety and tolerability profile that has supported ongoing clinical investigation in IPF, DMD, and LAPC. Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

About Roxadustat
Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for anemia of chronic kidney disease (CKD) and anemia associated with myelodysplastic syndromes (MDS), and for chemotherapy-induced anemia (CIA).

Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Several other licensing applications for roxadustat have been submitted by partners, Astellas and AstraZeneca to regulatory authorities across the globe, and are currently under review.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, and other markets not licensed to Astellas.

On November 7, 2022 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported that ONO Pharmaceutical Co., Ltd. (ONO) has exercised its option to FT825/ONO-8250, a multiplexed-engineered, iPSC-derived, chimeric antigen receptor (CAR) T-cell product candidate targeting human epidermal growth factor receptor 2 (HER2)-expressing solid tumors (Press release, Fate Therapeutics, NOV 7, 2022, View Source [SID1234623239]). The preclinical product candidate incorporates multiple functional elements to enhance the activity and overcome unique challenges in treating solid tumors with cell-based cancer immunotherapies.

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"We are encouraged by the compelling preclinical data package generated for FT825/ONO-8250 under our collaboration, which combines the antigen binder that ONO provides and Fate’s industry-leading iPSC product platform to overcome the challenges in solid cancer treatment," said Toichi Takino, Senior Executive Officer / Executive Director, Discovery & Research of ONO. "We look forward to initiating clinical development of the off-the-shelf, iPSC-derived CAR T-cell product candidate with the aim of delivering benefit to patients with some of the most difficult to treat cancers."

Under the terms of the Collaboration and Option Agreement, Fate will receive a milestone payment in connection with ONO’s exercise of its option to FT825/ONO-8250. The parties will jointly develop and commercialize FT825/ONO-8250 in the U.S. and Europe, and ONO maintains exclusive development and commercialization rights for FT825/ONO-8250 in the rest of the world. Fate is eligible to receive clinical, regulatory and commercial milestone payments as well as tiered royalties on net sales outside of the United States and Europe by ONO. The parties recently expanded their collaboration to initiate preclinical development of an additional program targeting a second solid tumor antigen.

"Over the past four years, we have worked closely with ONO to discover and integrate novel functional elements into our iPSC-derived CAR T-cell product platform that are specifically designed to address challenges in treating solid tumors, including cell trafficking and immune cell suppression in the tumor microenvironment," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "The preclinical data indicate FT825/ONO-8250 has a highly-differentiated therapeutic profile, including exhibiting anti-tumor activity against HER2-low tumor cells. We are excited to initiate IND-enabling activities under our collaboration with ONO with the goal of submitting an IND application to FDA in 2023."

Although CAR T-cell therapy has shown significant efficacy in treating hematologic malignancies, its wider application to solid tumors has been hampered by tumor-associated antigen heterogeneity, inefficient CAR T-cell trafficking to the tumor, and immunosuppression inherent to the tumor microenvironment. The Company’s multiplexed-engineered, iPSC-derived CAR T-cell product platform is designed to specifically address these challenges and enable the safe and effective treatment of solid tumors as monotherapy and in combination with monoclonal antibody therapy. At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting to be held from November 8-12, 2022 in Boston, the Company is presenting a poster presentation of FT825/ONO-8250 entitled "Off-the-shelf iPSC-derived CAR-T cells containing seven functional edits overcome antigen heterogeneity, improve trafficking and withstand immunosuppression associated with failed tumor treatment" (Abstract ID: 304; November 11, 2022, 9:00 AM – 9:00 PM), which highlights the incorporation of a synthetic CXCR2 receptor to promote cell trafficking, a synthetic TGFβ receptor to redirect immunosuppressive signals in the tumor microenvironment, and a synthetic interleukin-7 receptor fusion protein to induce T-cell activation into its iPSC-derived CAR T-cell product platform.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that are designed to be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

On November 7, 2022 EpiAxis Therapeutics reported that it has signed a material transfer agreement (MTA) with Seattle Children’s Research Institute that will help researchers study a new approach to treating paediatric brain cancer (Press release, EpiAxis Therapeutics, NOV 7, 2022, View Source;utm_medium=rss&utm_campaign=epiaxis-enters-agreement-with-seattle-childrens-research-institute [SID1234623238]).

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As part of the agreement, EpiAxis Therapeutics will supply its lead peptide candidates for assessment in the laboratory of Dr Myron Evans II, principal investigator at the Ben Towne Center for Childhood
Cancer Research at Seattle Children’s Research Institute and assistant professor in the Department of Pediatrics at the University of Washington School of Medicine, with the goal of informing a new
wave of brain tumour treatments that are more targeted than current therapies, with fewer side effects.

"Using novel inhibitors against LSD1 as a treatment for paediatric brain tumours has the potential to enhance efficacy, which could bypass a number of problems associated with existing chemotherapy
and radiotherapy," said EpiAxis Therapeutics CEO Dr. Jeremy Chrisp.

"Our first-in-class assets at EpiAxis Therapeutics have dual action and target dormant chemotherapy resistant cells while also improving the immune response against the persisting cells."EpiAxis is very pleased to be supplying our lead peptides candidates to Seattle Children’s in hope of accelerating innovation in the treatment of paediatric brain cancer."

Dr Evans II will be leading the project utilising EpiAxis’ lead peptide candidates. His research program focuses on epigenetic regulation in central nervous system development and how
deregulation contributes to paediatric brain tumours.

"For paediatric tumours, deregulation of normal epigenetic processes is central to tumour formation and provides novel avenues for targeted cancer therapy" said Dr Evans II.

"We are excited to work with EpiAxis to evaluate their peptides in the lab, and hopefully pursue them as novel therapies for children."

On November 7, 2022 Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported financial results for the third quarter of 2022 and highlighted recent corporate achievements (Press release, Day One, NOV 7, 2022, View Source [SID1234623237]).

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"Day One’s progress in 2022 has been remarkable. We announced positive interim results from our pivotal FIREFLY-1 study with tovorafenib in relapsed or progressive pLGG in patients harboring activating RAF alterations, completed a follow-on public offering, advanced our pivotal Phase 3 FIREFLY-2/LOGGIC trial for frontline pLGG as well as our Phase 2 FIRELIGHT-1 trial for MAPK-altered solid tumors, and recently entered into a CRADA agreement with the NCI to further expand therapeutic research opportunities using tovorafenib," said Jeremy Bender, Ph.D., chief executive officer of Day One. "With this significant momentum, we believe we are well-positioned to continue to execute on our mission. We look forward to the topline results from the full FIREFLY-1 pivotal study population, expected in the first quarter of 2023, and potential subsequent NDA submission to the FDA. 2023 is poised to be another pivotal year for Day One."

Program Highlights

Pivotal FIREFLY-1 trial of tovorafenib in relapsed or progressive pLGG in patients harboring activating RAF alterations continues to progress following positive initial data from the first 25 patients announced in June 2022.

Additional interim results from FIREFLY-1 will be presented at the Society for Neuro-Oncology (SNO) annual meeting in November 2022.

Day One is conducting a pivotal Phase 3 clinical trial (FIREFLY-2/LOGGIC) evaluating tovorafenib as a front-line therapy for patients newly diagnosed with pLGG.

The study is a randomized, monotherapy, open-label trial aiming to enroll approximately 400 patients aged 6 months to 25 years across approximately 100 sites globally, including in the United States, Europe and Asia.

The primary endpoint will be the ORR based upon Response Assessment for Neuro-Oncology (RANO) criteria as reported by Blinded Independent Central Review.

Secondary endpoints will include safety, progression-free survival, overall survival, duration of response, functional outcomes and quality of life measures.

Patient enrollment continues in the Phase 2 FIRELIGHT-1 trial evaluating tovorafenib as a monotherapy and as a combination with the company’s investigational MEK inhibitor, pimasertib, in adults and adolescents with recurrent, progressive, or refractory solid tumors harboring MAPK pathway aberrations.

Day One recently entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute’s (NCI) Division of Cancer Treatment and Diagnosis, Cancer Therapy Evaluation Program (CTEP) to expand therapeutic research opportunities using tovorafenib.
o
NCI investigators will have the opportunity to study tovorafenib in CTEP-sponsored trials to be conducted by NCI-funded extramural clinical networks in several solid tumor and hematologic cancers.

The company also recently announced a global collaboration with Foundation Medicine to develop FoundationOneCDx as a companion diagnostic for tovorafenib.

Corporate Highlights and Upcoming Milestones

Garry Nicholson was appointed as chairman of Day One’s board of directors. Mr. Nicholson brings more than 30 years of pharmaceutical and biotech oncology experience and previously served as president of Pfizer Oncology where he led its global oncology franchise.

Day One strengthened its leadership team with the appointment of Adam Dubow as general counsel. Mr. Dubow joins Day One following a 22-year tenure at Bristol Myers Squibb, where he most recently served as chief compliance and ethics officer and a member of the company’s management team.

Day One anticipates releasing topline results for the full FIREFLY-1 pivotal study population in the first quarter of 2023. If the data are supportive, Day One expects to submit a new drug application (NDA) to the United States Food and Drug Administration (FDA) in the first half of 2023.

Day One expects to dose the first patient in FIREFLY-2/LOGGIC trial in the fourth quarter of 2022.

Third Quarter 2022 Financial Highlights

Cash Position: Cash, cash equivalents and short-term investments totaled $374.3 million on September 30, 2022. Based on Day One’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations into 2025.

R&D Expenses: Research and development expenses were $22.0 million for the third quarter of 2022 compared to $9.8 million for the third quarter of 2021. The increase was primarily due to additional employee compensation costs, clinical trial and pre-commercial manufacturing activities related to Day One’s lead product candidate, tovorafenib.

G&A Expenses: General and administrative expenses were $17.7 million for the third quarter of 2022 compared to $9.4 million for the third quarter of 2021. The increase was primarily due to additional employee compensation costs, an ongoing commercial buildout, and professional service expenses to support company growth.

Net Loss: Net loss totaled $37.8 million for the third quarter of 2022 compared to $19.2 million for the third quarter of 2021 with non-cash stock compensation expense of $8.6 million and $5.1 million for the third quarters of 2022 and 2021, respectively.

Upcoming Events

Society for Neuro-Oncology (SNO) annual meeting, November 16-20, 2022

34th Annual Piper Sandler Healthcare Conference, November 29–December 1, 2022

Inducement Grants

In connection with Mr. Dubow’s appointment as general counsel, the compensation committee of the company’s board of directors granted Mr. Dubow 47,400 restricted stock units (RSUs) and 309,000 options to purchase shares of the company’s common stock on October 31, 2022 pursuant to the terms of the Company’s 2022 Equity Inducement Plan. The grants of the RSUs and options were approved by the compensation committee as inducements to Mr. Dubow commencing employment with Day One, in accordance with Nasdaq Marketplace Rule 5635(c)(4). The RSUs vest as to 25% on the first anniversary of the first Quarterly Vesting Date (as defined below), and 1/12th of the remaining RSUs will vest quarterly thereafter, on each applicable quarterly vesting date. For purposes of this announcement, "Quarterly Vesting Date" means February 15, May 15, August 15 or November 15. Each RSU is subject to the terms and conditions of the 2022 Equity Inducement Plan and restricted stock unit agreement covering the grant. The options have an exercise price per share equal to the closing selling price as reported on the Nasdaq Stock Market for the grant date. 1/4th of the options vest and become exercisable on the one-year anniversary of the grant date, and 1/48th of the options vest and become exercisable on a monthly basis thereafter, in each case, so long as the employee remains employed by Day One through the applicable vesting date. The options have a ten-year term and are subject to the terms and conditions of the 2022 Equity Inducement Plan and stock option agreement covering the grant.

About Tovorafenib

Tovorafenib is an investigational, oral, brain-penetrant, highly selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway, which is being investigated in primary brain tumors and solid tumors harboring activating RAF alterations. Tovorafenib has been studied in over 325 patients to date. Currently tovorafenib is under evaluation in a pivotal Phase 2 clinical trial (FIREFLY-1) among pediatric, adolescent and young adult patients with relapsed or progressive pediatric low-grade glioma (pLGG), which is an area of considerable unmet need with no approved therapies for the majority of patients. Day One has also initiated a pivotal Phase 3 study (FIREFLY-2/LOGGIC) in newly-diagnosed patients with pLGG. Beyond pLGG, tovorafenib is being evaluated alone or as a combination therapy for adolescent and adult patient populations with recurrent or progressive solid tumors with MAPK pathway aberrations (FIRELIGHT-1). Tovorafenib has been granted Breakthrough Therapy and Rare Pediatric Disease designations by the U.S. Food and Drug Administration (FDA) for the treatment of patients with pLGG harboring an activating RAF alteration. Tovorafenib has also received Orphan Drug designation from the FDA for the treatment of malignant glioma, and from the European Commission (EC) for the treatment of glioma.

About Pimasertib

Pimasertib is an investigational, oral, highly selective, small molecule inhibitor of mitogen‐activated protein kinases 1 and 2 (MEK-1/-2) within the MAPK signaling pathway. Pimasertib has been dosed in over 850 patients to date for various tumor types. Preclinical data indicates that the combination of a MEK inhibitor, such as pimasertib, and a type II RAF inhibitor, such as tovorafenib, has synergistic anti-tumor activity.

Day One is conducting a Phase 1b/2 study (FIRELIGHT-1) to evaluate the safety, tolerability, and preliminary efficacy of combining pimasertib with tovorafenib in adolescent and adult patients (≥12 years of age) with recurrent, progressive, or refractory solid tumors with MAPK pathway aberrations.