On March 7, 2022, Syros Pharmaceuticals, Inc. (the "Company") reported that it entered into a Master Collaboration Agreement and a project schedule (collectively, the "Agreement"), with QIAGEN Manchester Limited ("QIAGEN") (Filing, 8-K, Syros Pharmaceuticals, MAR 7, 2022, View Source [SID1234609627]). Pursuant to the Agreement, QIAGEN has agreed to develop and commercialize an assay as a companion diagnostic test to determine the expression level of the Company’s proprietary RARA biomarker for use with tamibarotene, a selective retinoic acid receptor alpha, or RARα, agonist, in newly diagnosed higher-risk MDS patients.

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Under the Agreement, QIAGEN is responsible for developing, and obtaining and maintaining regulatory approvals for the companion diagnostic test in the United States and, at the request of Syros and subject to the negotiation of mutually agreed payments, in the following additional markets: Canada, the United Kingdom, the member states of the European Economic Area, Switzerland, Mexico, Australia, Russia, Israel and Brazil (the "Additional Markets"). In addition, QIAGEN has agreed to use commercially reasonable efforts to manufacture the companion diagnostic test and, upon negotiation of mutually agreed terms, to make the companion diagnostic test commercially available in the United States, the Additional Markets and such other countries as the parties may mutually agree. QIAGEN has agreed to undertake specified actions to minimize the risk of an inability of supply occurring for the manufacture of the companion diagnostic test.

Subject to the terms of the Agreement and upon achievement of specified technical and development milestones, the Company is obligated to pay QIAGEN an amount up to a high single-digit million-dollar payment over the term of the initial project schedule in connection with developing and obtaining and maintaining regulatory approval for the companion diagnostic in the United States. In addition, the Company will reimburse QIAGEN for certain pass-through costs. These amounts are subject to adjustment if the parties determine that changes in the scope of the development program are required. In addition, QIAGEN will retain all proceeds from the commercialization of the companion diagnostic test. Syros has no financial obligations to QIAGEN under the Agreement on the commercialization of tamibarotene.

The initial term of the Agreement expires on the later to occur of (i) the fifth anniversary of the Agreement and (ii) the expiration or termination of all project schedules executed under the Agreement. Thereafter, the Agreement automatically renews for additional periods of one year. The Company may terminate the Agreement or a project schedule executed under the Agreement for convenience upon 90 day’s prior written notice to QIAGEN. Either party may terminate the Agreement or any project schedule executed under the Agreement, as applicable, upon a material breach of the other party that is not cured within 30 days after written notice of such breach, immediately upon the bankruptcy or insolvency of the other party, or in certain other circumstances described in the Agreement. In the event of a termination of the Agreement by the Company for reasons other than QIAGEN’s material breach or bankruptcy, the Company will be obligated to pay QIAGEN wind-down and other costs and other final payments.

The foregoing description of the material terms of the Agreement is qualified in its entirety by reference to the complete text of the Agreement, which the Company intends to file, with confidential terms redacted, with the Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022.

On March 7, 2022 Novo Nordisk reported that it initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, MAR 7, 2022, View Source [SID1234609622]). This programme is part of the overall share repurchase programme of up to DKK 22 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 2 February 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 2 February 2022 to 2 May 2022.

With the transactions stated above, Novo Nordisk owns a total of 34,280,319 B shares of DKK 0.20 as treasury shares, corresponding to 1.5% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 22 billion during a 12- month period beginning 2 February 2022. As of 4 March 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 2,494,151 B shares at an average share price of DKK 670,38 per B share equal to a transaction value of DKK 1,672,029,156.

On March 7, 2022 Arctoris, a tech-enabled biopharma company, and Evariste Technologies, an AI-drug discovery company, reported they have formed a joint venture to identify novel small molecule kinase inhibitors for treatment of patients with Non-Small Cell Lung Cancer (NSCLC) (Press release, Lifescience Newswire, MAR 7, 2022, View Source [SID1234609620]).

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Current treatment options for NSCLC are limited, especially in advanced stages. It has been shown that the proto-oncogene cMet is mutated or upregulated in approximately 5% of all NSCLC cases. While cMET has been successfully targeted by two recently approved drugs (Tepotinib, Capmatinib), rapid development of resistance has been reported and there is a clear need for improved second-generation cMET inhibitors to overcome resistance.

The two companies are combining their platforms for AI-guided and robotics-powered drug discovery to develop a set of novel kinase inhibitors against cMET. The partnership will bring together two highly synergistic approaches – quantitative decision making and state-of-the-art generative chemistry, combined with real-time biological and biochemical profiling and data generation, to significantly accelerate the design-make-test-analyze cycle. The two companies will also use their strong links to leading centres for NSCLC treatment to leverage clinical insights, inform their discovery and development efforts and directly address clinically relevant liabilities limiting the effectiveness of currently available therapies.

"We are really excited to be working with Arctoris on this project. There is a huge need for next generation cMET inhibitors for NSCLC. This is a cancer that affects millions globally, and we hope that we can bring meaningful benefit to some of these lives in the near future," shares Dr. Nicholas Firth, CEO of Evariste Technologies.

Arctoris CEO Martin-Immanuel Bittner MD DPhil FRSA commented on the joint venture, "Together with our partners at Evariste, we are developing novel treatment options in NSCLC against a fully validated target, where first generation inhibitors can be improved on in a clinically meaningful way. Combining patient-derived insights on resistance and toxicity patterns with AI-powered molecule design and our robotic platform, Ulysses, we aim to develop superior next generation inhibitors within a significantly accelerated time frame."

The collaboration between Arctoris and Evariste is already underway and has identified novel, active chemical matter. "We look forward to keeping our community updated about the progress we are making within the joint venture between Evariste Technologies and Arctoris. We have had an incredible start already, and we look forward to continuing our work to develop better treatments options for patients worldwide", shares Bittner.

On March 7, 2022 Jounce Therapeutics Presented the Corporate Presentation (Press release, Jounce Therapeutics, MAR 7, 2022, View Source [SID1234609619]).

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On March 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 its fourth quarter and full year 2021 financial results and highlighted recent corporate achievements (Press release, Day One, MAR 7, 2022, View Source [SID1234609618]).

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"Our clinical and corporate achievements in 2021 have set a solid foundation for a potentially transformational next 12 months," said Jeremy Bender, Ph.D., chief executive officer of Day One. "We expect to report the initial data from our pivotal Phase 2 FIREFLY-1 trial of DAY101 in relapsed pediatric low-grade glioma in June of 2022 followed by topline results in the first quarter of 2023. In addition, we are enrolling patients in our Phase 2 FIRELIGHT-1 monotherapy trial of DAY101 in RAF-altered solid tumors and are preparing to initiate a Phase 1b/2 combination portion of the study with our oral MEK inhibitor, pimasertib. As our clinical development programs continue to advance and expand, we remain well-capitalized to fund our operations into 2024 and we will continue to execute on our mission to provide innovative targeted therapies for people of all ages."

Program Highlights

•Initial data from FIREFLY-1, a pivotal Phase 2 clinical trial of DAY101 (tovorafenib) in pediatric low-grade glioma (pLGG), is expected in June 2022.

•FIREFLY-1 has reached targeted enrollment across approximately 30 sites globally. Day One anticipates releasing topline results from the study in the first quarter of 2023. Pending positive results from FIREFLY-1, Day One anticipates filing a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) in 2023.

•The first patient has been dosed with a pediatric formulation in the FIREFLY-1 study.

•The Company plans to initiate a pivotal Phase 3 clinical trial (FIREFLY-2) evaluating DAY101 as a first-line therapy in pLGG in the second quarter of 2022.

•Day One is enrolling patients in the Phase 2 FIRELIGHT-1 trial evaluating DAY101 monotherapy in adults with recurrent, progressive, or refractory solid tumors harboring MAPK pathway aberrations, with 8 sites activated. Day One plans to expand FIRELIGHT-1 to include a Phase 1b/2 portion to evaluate DAY101 in combination with pimasertib, the Company’s MEK Inhibitor. The Company expects to initiate the combination portion of the study in March of 2022.

Fourth Quarter and Full Year 2021 Financial Highlights

•Cash Position: Cash and cash equivalents totaled $284.3 million on December 31, 2021. Based on Day One’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations into 2024.

•R&D Expenses: Research and development expenses were $11.2 million and $43.6 million for the fourth quarter and full year ended December 31, 2021, respectively, as compared to $4.2 million and $9.1 million for the same periods in 2020. The increase was primarily due to additional employee compensation costs, milestone payments for licensing agreements, clinical trial, and product development expenses.

•G&A Expenses: General and administrative expenses were $10.8 million and $29.2 million for the fourth quarter and full year ended December 31, 2021, respectively, as compared to $2.0 million and $4.7 million for the same periods in 2020. The increase was primarily due to additional employee compensation costs, legal, and professional expenses associated with operating as a public company.

•Net Loss: Net loss totaled $21.9 million for the fourth quarter of 2021 with non-cash stock compensation expense of $5.1 million, compared to $35.6 million for the fourth quarter of 2020 with non-cash stock compensation expense of $0.4 million. Net loss was $72.8 million for the year ended December 31, 2021, with non-cash stock compensation expense of $13.3 million, compared to $43.8 million for the year ended December 31, 2020, with non-cash stock compensation expense of $0.5 million.

Upcoming Events

•Cowen 42nd Annual Health Care Conference
oManagement will participate in a fireside chat today, March 7 at 2:50 p.m. ET. A live and archived audio webcast of the discussion will be available by visiting the Events & Presentations section of the Company’s website.

About DAY101 (tovorafenib)

DAY101 (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. Studies have shown DAY101 has high brain distribution and exposure in comparison to other MAPK pathway inhibitors, thus potentially benefiting patients with primary brain tumors or brain metastases of solid tumors. DAY101 is a type II RAF inhibitor found to selectively inhibit both monomeric and dimeric RAF kinase.

DAY101 has been studied in over 250 patients, and as a monotherapy, previously demonstrated good tolerability and encouraging anti-tumor activity in pediatric and adult populations with specific MAPK pathway-alterations. DAY101 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with pLGG harboring an activating RAF alteration who require systemic therapy and who have either progressed following prior treatment or who have no satisfactory alternative treatment options. The FDA has also granted Rare Pediatric Disease Designation to DAY101 for the treatment of low-grade gliomas harboring an activating RAF alteration that disproportionately affects children. In addition, DAY101 has received Orphan Drug designation from the FDA for the treatment of malignant glioma and orphan designation from the European Commission for the treatment of glioma.

DAY101 is being evaluated in a pivotal Phase 2 clinical trial (FIREFLY-1) for the treatment of pediatric low-grade glioma (pLGG). pLGG is the most common form of childhood brain cancer with no approved therapies. Day One has also initiated a Phase 1b/2 study (FIRELIGHT-1) with DAY101 in patients with recurrent or progressive solid tumors with activating RAF alterations and additional studies are planned with DAY101 alone or in combination with other agents that target key signaling nodes in the MAPK pathway, such as the Company’s MEK inhibitor pimasertib, in patient populations where RAS and RAF alterations are believed to play an important role in driving disease.