On March 29, 2022 Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue degrader (MGD) medicines, reported business highlights and financial results for the fourth quarter and full year, ended December 31, 2021 (Press release, Monte Rosa Therapeutics, MAR 29, 2022, View Source [SID1234611090]).

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"Last year was transformational for Monte Rosa as we continued to build our world-class leadership team, expanded operations across our two sites in Boston and Basel, named MRT-2359 – our development candidate for the GSPT1 program – and secured $377.6 million in funding," said Markus Warmuth, M.D., CEO of Monte Rosa. "As we look to 2022, we anticipate significant pipeline progress, including the submission of our IND for MRT-2359, as well as continued lead optimization on our CDK2 and NEK7 programs. We are also seeing exciting advancements across our proprietary QuEEN platform, including the expansion of our understanding of structural characteristics of degradable proteins driven by both our experimental and AI platforms. We believe we are well-positioned both organizationally and financially to execute on our vision of tackling historically undruggable targets and identifying potent, highly selective therapies for patients with few or no treatment options."

FOURTH QUARTER 2021 & RECENT HIGHLIGHTS

•Presented preclinical data for MRT-2359 demonstrating anti-tumor activity in L- and N-Myc-positive non-small cell lung cancer patient-derived xenograft (PDX) models. The data were featured as part of the company’s presentation at the 40th Annual J.P. Morgan Healthcare Conference. MRT-2359 is a potent, selective and orally bioavailable GSPT1-directed molecular glue degrader. MRT-2359 has been shown to induce tumor regression in multiple Myc-driven preclinical models, including models of non-small cell lung cancer and small cell lung cancer

•Advanced CDK2 degrader program into lead optimization. Leveraging the company’s QuEEN platform, Monte Rosa has identified selective MGDs for CDK2, a highly validated oncogenic driver of breast, gynecological and other cancers

•Announced license and research collaboration agreement with Dr. Nir London and the Yeda Research and Development Company Ltd., the commercial arm of the Weizmann Institute of Science. The goal of the collaboration is to leverage innovative covalent chemistry to further expand the target space for molecular glue degradation

•Strengthened executive leadership team with promotions of Jullian Jones, Ph.D., J.D., MBA, to Chief Business Officer and Phil Nickson, Ph.D., J.D., to General Counsel

•Presented at recent scientific and medical conferences, including:
•3rd Annual Protein Degradation and Targeting Undruggables Congress, March 8-9
•ESMO Targeted Anticancer Therapies Congress 2022, March 7-8
•2nd Annual Targeted Protein Degradation Europe, March 15-17

UPCOMING MILESTONES & DATA PRESENTATIONS

•Submission of Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MRT-2359 expected in mid-2022

•Initiation of at least one additional lead optimization program expected in 2022

•Share new preclinical data supporting MRT-2359 program in a poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, hosted April 8-13, 2022, in New Orleans; presentation details, as follows:
Title: Identification of MRT-2359 a potent, selective and orally bioavailable GSPT1-directed molecular glue degrader (MGD) for the treatment of cancers with Myc-induced translational addiction

Abstract: 3929

Presenter: Gerald Gavory, Ph.D.

Date and Time: April 13, 2022, 9:00 AM – 12:30 PM

UPCOMING INVESTOR EVENTS

Monte Rosa will be participating in the following upcoming investor conferences:

•Wells Fargo Biotech Forum, April 11-13
•Piper Sandler Boston Biotech Bus Tour, May 4-5
•UBS Global Healthcare Conference, May 23-25
•Jefferies Global Healthcare Conference, June 8-10

FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS

Research and Development (R&D) Expenses: R&D expenses were $18.1 million for the fourth quarter of 2021 and $57.2 million for the year ended December 31, 2021, compared to $9.9 million and $24.0 million, respectively for the same periods of 2020. These increases were due to the expansion of research and development activities, including the development of our QuEEN

ACTIVE/115879056.5

platform and discovery, lead optimization efforts of our GSPT1 program, and the advancement of development candidate MRT-2359, as well as increases in headcount and laboratory-related expenses due to our continued growth as a research and development organization. R&D expenses included non-cash stock-based compensation of $1.0 million for the fourth quarter of 2021 and $2.6 million for the year ended December 31, 2021, compared to $0.1 million and $0.2 million, respectively, for the same periods in 2020.

General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2021 were $5.3 million compared to $2.1 million for the fourth quarter of 2020, and $15.7 million for the year ended December 31, 2021, compared to $4.0 million for the year ended December 31, 2020. The increase in G&A expenses were a result of increased headcount and expenses in support of the company’s growth and operations as a public company and director and officer liability insurance. G&A expenses included non-cash stock-based compensation of $1.0 million for the fourth quarter of 2021 and $2.6 million for the year ended December 31, 2021, compared to $0.1 million and $0.2 million, respectively, for the same periods in 2020.

Net Loss: Net loss for the fourth quarter of 2021 was $23.4 million compared to $19.7 million for the fourth quarter of 2020, and $74.0 million for the year ended December 31, 2021, compared to $35.9 million for the year ended December 21, 2020.

Cash Position and Financial Guidance: Cash, cash equivalents and restricted cash as of December 31, 2021, were $351.4 million, compared to $42.9 million as of December 31, 2020. The company expects that its cash and cash equivalents, including the aggregate net proceeds from the initial public offering, will be sufficient to fund planned operations and capital expenditures into late 2024.

On March 29, 2022 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, reported the signing of an exclusive global supply and licensing agreement with Heska Corporation (NASDAQ: HSKA) ("Heska") to sell its Nu.Q Vet Cancer Screening Test at the point of care for companion animals. Heska is a leading global provider of advanced veterinary diagnostics (Press release, VolitionRX, MAR 29, 2022, View Source [SID1234611115]).

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In exchange for granting Heska these exclusive worldwide rights to sell the Nu.Q Vet Cancer Test, Volition will receive:

a $10 million upfront payment on signing, and

up to $18 million based upon the achievement of near/mid-term milestones.

Volition’s licensing agreement with Heska grants exclusive rights to commercialize the Nu.Q Vet Cancer Screening Test for canine cancer screening and monitoring at the point of care. It also enables Heska to access a wider test menu for companion animals, including feline cancer.

In addition, Volition has granted Heska non-exclusive rights to sell the Nu.Q Vet Cancer Screening Test in kit format for companion animals, through Heska’s network of central reference laboratories.

An interview with Dr. Tom Butera, Chief Executive Officer, Volition Veterinary and Kevin Wilson, President and Chief Executive Officer, Heska Corporation.

View Source

Volition’s Nu.Q Vet Cancer Screening Test will operate on Heska’s proprietary Element i+ Immunodiagnostic Analyzer, a point of care platform. By running Nu.Q Vet Cancer Screening Test on Heska’s proprietary analyzers and tests, veterinarians will be able to screen millions of pets for some of the most common cancers to provide critical information to pet families accurately, cost effectively, and conveniently at the point of care. Heska’s Nu.Q Vet Cancer Screening Test targets one of the most critical challenges in pet healthcare.

"We are thrilled to announce this agreement with Heska, a company dedicated to developing the next generation of rapid, highly affordable, point-of-care diagnostics for companion animals," commented Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC. "We estimate the total addressable market worldwide for cancer screening and monitoring in canines and felines to be approximately $11 billion and growing. As such, we want to make our Nu.Q Vet Cancer Screening Test as accessible as possible to veterinarians around the world, ensure cancer is detected earlier, and improve outcomes for pets and pet owners. Working with Heska, and its global network will enable us to do just that. I am delighted Heska shares our vision of keeping tests very affordable, and we look forward to fostering a successful relationship together and generating ongoing revenue by providing kits and key components to veterinarians around the world."

"Heska is committed to delivering market-leading technologies to veterinarians through targeted research and development investments and strategic partnerships to get the most urgent innovations into veterinarians’ hands quickly," commented Kevin Wilson, Heska’s Chief Executive Officer and President. "The accurate, affordable, fast and non-invasive Nu.Q Vet Cancer Screening Test is exactly such an innovation and is a perfect addition to our Heska test menu, which we believe is now the most complete, differentiated and cutting-edge point of care diagnostics solutions stack available for pet healthcare professionals and pet families. With the new Heska Nu.Q Vet Cancer Screening Test millions of pets will have access to critical cancer screening and monitoring instantly, and at the point of care, to catch, treat and drive recovery from cancers earlier and with much better healthcare outcomes and peace of mind."

Mr. Wilson continued, "Delivering the best care means finding and treating conditions as early as possible in pets who cannot speak for themselves; we must become the voice of the pet to help guide their caregivers. Upon commercialization, which could begin as early as late 2022, we believe our Heska Nu.Q Vet Cancer Screening Test will allow veterinarians across the globe to detect cancer early, in the clinic, in minutes, and for under $50 to support clinical decisions during annual check-ups, regular wellness exams, healthcare interventions, treatment cycles, and remission. Additionally, we see a clear path to developments covering cat cancers and for inclusion of Nu.Q cancer results on multiplexed Heska panels with other key diagnostics relied upon by veterinarians. Leading in cancer will do a great amount of good and I anticipate will accelerate Heska’s 2023 and beyond financial performance even faster than I previously expected."

The Veterinary Cancer Society estimates one in four dogs and nearly 50% of dogs over the age of 10 will develop cancer. According to the National Cancer Institute, in the U.S. approximately six million new cancer diagnoses are made in dogs each year.

Volition is developing simple, easy-to-use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases including cancer in both humans and animals. For more information about Volition’s Nu.Q technology go to: www.volition.com

Findings from two studies conducted by Volition and Professor Wilson-Robles and her team at Texas A&M University, peer-reviewed and published in 2021, showed that:

Volition’s Nu.Q Vet Cancer Screening Test detected 77% of lymphoma at 97% specificity versus control including all stages of lymphoma.

Volition’s Nu.Q Vet Cancer Screening Test detected 82% of hemangiosarcoma at 97% specificity versus control including stages I through III of hemangiosarcoma.

Volition introduced its Nu.Q Vet Cancer Test via a beta launch in collaboration with Texas A&M University in late 2020 and more recently appointed SAGE Healthcare as a non-exclusive licensee and distributor for Singapore ensuring wide access to Volition’s Nu.Q Vet Cancer Screening Test.

About the market

According to the National Cancer Institute, approximately 6 million new cancer diagnoses are made in dogs each year.

The Veterinary Cancer Society estimates 1 in 4 dogs will develop cancer at some point, and almost 50% of dogs over age 10 will develop cancer.

Approximately 470 million dogs live as pets worldwide and a 2021 U.S Morgan Stanley / AlphaWise survey found that 69% of respondents "strongly agree" that their pets are important members of the family.

The Morgan Stanley / AlphaWise report also projected the pet care industry will reach $275 billion in 2030, reflecting an 8% topline compounded annual growth rate.

A 2021 survey by VetSuccess also showed Pet Patient Visits have increased by 5.1% with strong growth in particular for wellness visits (up 5%-7%).

On March 29, 2022 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a late clinical stage biopharmaceutical company focused on helping patients fight cancer with oncolytic viral immunotherapies, reported financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update (Press release, Candel Therapeutics, MAR 29, 2022, View Source [SID1234611131]).

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"2021 was a year of significant progress for Candel, filled with important accomplishments in development of our late-stage pipeline of novel oncolytic viral immunotherapies for cancer treatment. We strengthened our organization for future growth with our successful initial public offering, by meeting key clinical trial accrual milestones and by enhancing our talent pool," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "Today, we are well positioned for major catalysts over the next 12 months, namely, multiple data readouts across our product candidates and advancement of our pipeline of promising therapeutics with potential to treat various solid tumors, including lung, brain, pancreatic and prostate cancer. We look forward to delivering on our mission to develop oncolytic viral immunotherapies aimed at tipping the balance in favor of the patient’s immune system to fight cancer."

Fourth Quarter 2021 & Recent Highlights

Presented Candel’s novel oncolytic viral immunotherapies at several preeminent industry conferences:
October 2021: Cambridge Healthtech Institute’s 9th Annual Immuno-Oncology Summit
October 2021: Hanson Wade 6th Annual Oncolytic Virotherapy Summit
October 2021: 28th Annual Prostate Cancer Foundation Scientific Retreat
November 2021: 13th International Oncolytic Virus Conference Meeting
November 2021: Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting
Patrick Y. Wen, MD, principal investigator, presented initial safety data on CAN-2409 in combination with nivolumab from Candel’s Phase 1 clinical trial in high-grade glioma at the 26th Annual Meeting of the Society for Neuro-Oncology in November 2021.
Established a collaboration with Partnership for Accelerating Cancer Therapies and the Cancer Immune Monitoring and Analysis Centers – Cancer Immunologic Data Commons to profile the biomarker response to a combination of CAN-2409 and valacyclovir, in combination with anti-PD-1 and PD-L1 immune checkpoint inhibitors in patients with non-small cell lung cancer (NSCLC) in December 2021.
Enhanced executive leadership with the promotion of Francesca Barone, MD, PhD to Chief Scientific Officer and appointment of Seshu Tyagarajan, PhD, RAC as Chief Technical and Development Officer in 2022.
Strengthened cash position with non-dilutive debt financing with Silicon Valley Bank (SVB) in February 2022.
Appointed Mace Rothenberg, MD, prior Chief Medical Officer of Pfizer, as Senior Advisor to the CEO.
Key Upcoming Milestones

The Company expects to present initial data from an ongoing Phase 2 clinical trial of CAN-2409 and valacyclovir combined with PD-1 or PD-L1 targeting agents in patients with NSCLC in June 2022.
In the fourth quarter of 2022, the Company expects to present data from two high grade glioma clinical trials – a Phase 1b clinical trial of CAN-2409 in combination with nivolumab (Opdivo) combined with standard of care first line treatment and a Phase 1 clinical trial of CAN-3110 in recurrent high-grade glioma.
Financial Results for the Year and Fourth Quarter Ended December 31, 2021

Cash Position: Cash and cash equivalents as of December 31, 2021 were $82.6 million, compared to $35.1 million as of December 31, 2020. The increase was due to receipt of $71.3 million of net proceeds from the Company’s successful initial public offering (IPO) of common stock in August 2021. In addition, the Company utilized $22.2 million in the year ended December 31, 2021 to fund operating activities. Subsequent to December 31, 2021, the Company entered into a term loan agreement with SVB and borrowed $20.0 million. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents, including the $20 million in term loan proceeds, will be sufficient to fund its operations into the fourth quarter of 2023.

Research & Development Expenses: Research and development expenses were $3.9 million and $15.2 million for the three- and twelve-month periods ended December 31, 2021, respectively, as compared to $3.5 million and $8.8 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount to support the ongoing clinical trials for Candel’s product candidates as well as increased clinical development costs related to our clinical trial sites and the cost of treatment and follow-up on patients. Excluding stock-based compensation expense of ($810,000) and $1.2 million for the three- and twelve-month periods ended December 31, 2021, respectively, research and development expenses for the three- and twelve-month periods ended December 31, 2021, were $4.7 million and $14.0 million, respectively.

General and Administrative Expenses: General and administrative expenses were $3.9 million and $10.7 million for the three- and twelve-month periods ended December 31, 2021, respectively, as compared to $2.6 million and $5.2 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount required to support the growth of the Company and the transition to a public company, an increase in professional fees associated with Candel’s preparation for the IPO completed in August 2021 and costs associated with operating as a public company. Excluding stock-based compensation expense of $364,000 and $1.7 million for the three- and twelve-month periods ended December 31, 2021, respectively, general and administrative expenses for the three- and twelve-month periods ended December 31, 2021, were $3.5 million and $9.0 million, respectively.

Total Operating Expenses: Total operating expenses were $7.8 million and $25.9 million for the three- and twelve-month periods ended December 31, 2021, respectively, as compared to $6.2 million and $13.9 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount required to support the growth of the Company and the transition to a public company, an increase in professional fees associated with Candel’s preparation for the IPO completed in August 2021, an increase in costs associated with operating as a public company and increased clinical development costs. Excluding stock-based compensation expense of ($446,000) and $2.9 million for the three- and twelve-month periods ended December 31, 2021, respectively, total operating expenses for the three- and twelve-month periods ended December 31, 2021, were $8.2 million and $23.0 million, respectively.

Net Loss: Net (income) loss was ($1.6 million) and $36.1 million for the three- and twelve-month periods ended December 31, 2021, respectively, as compared to a net loss of $10.5 million and $17.7 million for the comparable periods of 2020. The net (income) loss for the three- and twelve-month periods ended December 31, 2021, includes a noncash credit and charge of ($9.2 million) and $11.4 million, respectively, for the change in the fair value of the Company’s warrant liability and stock-based compensation expense of ($446,000) and $3.0 million, respectively. Excluding the noncash charges for the change in the warrant liability and the stock-based compensation, the net loss for the three- and twelve-month periods ended December 31, 2021, was $8.0 million and $21.7 million, respectively.

On March 29, 2022 XNK Therapeutics AB ("XNK") reported it has secured a private placement of SEK 132 million, to existing and new investors, led by Flerie Invest AB (Press release, XNK Therapeutics, MAR 29, 2022, View Source [SID1234611152]). The purpose of the issue is primarily to finance the company’s clinical development in multiple myeloma and other indications.

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XNK is at the global forefront of the development of autologous NK cell-based products using its proprietary technology platform. The company’s lead investigational candidate drug is currently being evaluated in combination with Sanofi’s anti-CD38 antibody Sarclisa (Isatuximab) in a Phase II clinical study in multiple myeloma.

Flerie Invest led the SEK 132 million financing by placing SEK 100 million and thus gains approximately 22 percent of the total number of shares and votes in the company becoming XNK’s largest owner. Ted Fjällman, partner at Flerie Invest, will as a result of the investment join the board of directors.

"This substantial fundraising is an important milestone for XNK. It allows us to accelerate our global growth initiatives and invest in the further development of our product portfolio in multiple myeloma and other cancer indications, such as our ongoing proof of concept study in acute myeloid leukemia (AML) using patient samples from The University of Texas MD Anderson Cancer Center. We are thankful for the continued support of our current shareholders and excited to further strengthen our specialist investor base with Flerie Invest and welcome them as a new shareholder." said Johan Liwing, CEO of XNK Therapeutics.

"XNK Therapeutics and the innovation ecosystem around Karolinska University Hospital in Stockholm have long been at the forefront of clinical cell therapy development" said Ted Fjällman. "We’re excited to lead this round and use our network to further commercialise the company and in so doing bring cell therapies to more patients."

XNK has engaged ABG Sundal Collier AB as financial adviser. The private placement is subject to approval by an extraordinary general meeting, which is scheduled to be held on April 5, 2022.

On March 29, 2022 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline and business progress and fourth quarter and full year 2021 financial results (Press release, Nuvalent, MAR 29, 2022, View Source [SID1234611091]).

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As part of today’s update, Nuvalent is announcing that its Investigational New Drug (IND) application for NVL-655 for the treatment of ALK-positive NSCLC and other solid tumors was cleared by the U.S. Food and Drug Administration (FDA). NVL-655 is a novel ALK-selective inhibitor designed with the aim to address the clinical challenges of emergent treatment resistance, central nervous system (CNS)-related adverse events, and brain metastases that may limit the use of currently available ALK inhibitors. Nuvalent plans to initiate the ALKOVE-1 Phase 1/2 study of NVL-655 for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors in the second quarter of 2022.

"The Nuvalent team has continued to demonstrate the ability to discover novel molecules with preclinical profiles suggesting best-in-class potential and to progress them efficiently into clinical development. With the clearance of our IND for NVL-655, Nuvalent is on track to have two parallel lead compounds in clinical trials by mid-year," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We believe we are well positioned with two clinical-stage, novel product candidates in areas of significant medical need, and sustainable internal discovery efforts with the goal of delivering multiple additional product candidates. I am incredibly proud of all that this team has accomplished and their continued dedication to advancing new potential therapeutic options for patients in need."

Recent Pipeline Highlights

Enrollment Ongoing in ARROS-1 Trial of NVL-520 for Patients with Advanced ROS1-positive NSCLC: Nuvalent is actively enrolling patients in the Phase 1 portion of its ARROS-1 clinical trial, a Phase 1/2 study evaluating NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors. NVL-520, Nuvalent’s lead product candidate, is a novel ROS1-selective inhibitor designed with the aim to address the clinical challenges of emergent treatment resistance, CNS adverse events, and brain metastases that may limit the use of currently available ROS1 kinase inhibitors.
Discovery Pipeline Advancing toward Selection of Next Development Candidates: Nuvalent continues to advance its early pipeline efforts with multiple discovery-stage research programs. The company expects to nominate product candidates in 2022 for its discovery programs directed toward ALK IXDN compound resistance mutations and HER2 exon 20 insertions.
Recent Business Highlights

Strengthened Board of Directors with Appointment of Emily Drabant Conley, Ph.D.: In February 2022, Nuvalent appointed Emily Drabant Conley, Ph.D., Chief Executive Officer of Federation Bio, to its Board of Directors. Dr. Conley’s work has contributed to industry-shaping advances in genomics that empower patients and clinicians with actionable health data. Prior to Federation Bio, she spent over a decade at 23andMe where, as Vice President of Business Development, she was instrumental in powering the company’s growth from 30 employees into a household name.
Fourth Quarter and Full Year 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $288.1 million as of December 31, 2021. Nuvalent expects that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into 2024.
R&D Expenses: Research and development (R&D) expenses were $13.2 million for the quarter ended December 31, 2021, and $35.6 million for the year ended December 31, 2021.
G&A Expenses: General and administrative (G&A) expenses were $4.2 million for the quarter ended December 31, 2021, and $10.3 million for the year ended December 31, 2021.
Net Loss: Net loss was $17.3 million for the quarter ended December 31, 2021, and $46.3 million for the year ended December 31, 2021.