Nuvalent Announces Business and Program Highlights and Reports Second Quarter 2021 Financial Results

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IND application for NVL-520 approved by US FDA; The company plans to launch a phase 1/2 clinical trial in the second half of 2021

$ 190.6 million Expanded IPO Completed to Fund Continued Advancement of New Portfolio of Precisely Targeted Kinase Inhibitors

The leadership team is further strengthened with the appointments of Deborah Miller, Ph.D., JD, as General Counsel and Sapna Srivastava, Ph.D., to the Board of Directors

CAMBRIDGE, Mass., September 8, 2021 / PRNewswire / – Nuvalent, Inc., (Nasdaq: NULV), a biopharmaceutical company focused on creating precisely Targeted therapies for clinically proven kinase targets in cancer, today announced recent pipeline and business highlights and second quarter 2021 financial results.

Nuvalent, Inc. (PRNewsfoto / Nuvalent, Inc.)

“At Nuvalent, we are leveraging our team’s deep expertise in chemistry and structure-based drug design to advance a new pipeline of product candidates for cancer patients. Our therapies are specifically designed to address issues limiting the activity and durability of currently available therapies. , such as kinase resistance, adverse events due to off-target activity, and brain metastases, “said James porter, Ph.D., CEO of Nuvalent. “In the first half of 2021, our team made significant progress in realizing our clear vision of advancing the field of precision oncology. We have received FDA clearance to continue the Phase 1/2 study for our selective ROS1 inhibitor. NVL-520, advanced our parallel product candidate, the selective ALK inhibitor NVL-655, in studies enabling IND, and advanced several additional research programs in the discovery phase. IPO, we are well positioned to fuel our next transition to a clinical organization and our efforts to bring hope to patients in need. “

Highlights of the second quarter

  • IND application for NVL-520 approved by the FDA, allowing the initiation of clinical trials: The United States Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for NVL-520, its selective brain-penetrating ROS1 inhibitor. The company is preparing to launch Phase 1 of a global Phase 1/2 clinical trial for NVL-520 in patients with ROS1-positive NSCLC and other advanced solid tumors in the second half of 2021.

  • $ 190.6 million Oversized initial public offering (IPO) successfully completed: In July 2021, Nuvalent sold 11,212,500 ordinary shares at a public price of $ 17.00 per share. The gross proceeds of the offer were approximately $ 190.6 million, before deduction of subscription discounts and commissions and other offering costs.

  • Leadership of the company reinforced by appointments to management and the board of directors: Newly appointed Nuvalent Deborah Miller, Ph.D., JD, as General Counsel, and Sapna Srivastava, Ph.D., CFO of eGenesis, to its board of directors.

Dr. Miller most recently served as Senior Vice President, Assistant General Counsel and General Counsel of Intellectual Property for Sumitomo Dainippon Pharma America (SDPA). Previously, Dr. Miller was Deputy General Counsel and Chief Intellectual Property Counsel at Sunovion Pharmaceuticals Inc., a subsidiary of SDPA. Previously, she held various positions at Infinity Pharmaceuticals, Inc., including Vice President, Assistant General Counsel and Chief Patent Advisor, where she created and managed the Intellectual Property Group and supported various licensing initiatives. licensing, licensing and financing. Earlier in her career, Ms. Miller was intellectual property legal counsel at Sepracor Inc. (currently Sunovion Pharmaceuticals Inc.) and a partner at the law firm Nutter McClennen & Fish LLP. Dr. Miller got his JD from Suffolk University Faculty of Law, Ph.D. in Biological Chemistry and Molecular Pharmacology of Harvard University, MS in Medical Sciences from Harvard Medical School and BS in chemistry from Swarthmore College.

Dr Srivastava brings more than 20 years of experience as a senior executive in the biopharmaceutical industry. She has been CFO of eGenesis Bio since April 2021. Prior to eGenesis, she held similar positions as CFO and Strategic Director at Abide Therapeutics (acquired by Lundbeck) and at Intellia Therapeutics. Prior to Intellia, Dr Srivastava was a senior biotechnology analyst at Goldman Sachs, Morgan Stanley and ThinkEquity Partners, and began her career as a research associate at JP Morgan. Dr. Srivastava obtained her doctorate. in neuroscience New York University Faculty of Medicine and its bachelor’s degree in biology from St. Xavier College at Bombay University.

Second Quarter 2021 Financial Results

  • As of June 30, 2021, Nuvalent had cash of $ 138.9 million, which does not include the net proceeds of its initial public offering, which closed on August 2nd, 2021.

  • Research & Development expenses for the second quarter of 2021 were $ 7.8 million.

  • General and administrative expenses for the second quarter of 2021 were $ 2.0 million.

  • The net loss for the second quarter was $ 9.8 million, Where $ 3.17 per share.

About Nuvalent

Nuvalent, Inc. (Nasdaq: NUVL) is a pre-clinical biopharmaceutical company focused on creating precisely targeted therapies for cancer patients, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we are developing innovative small molecules that have the potential to overcome resistance, minimize adverse events, treat brain metastases, and generate responses more durable. Nuvalent is advancing a strong pipeline with parallel programs in ROS1 positive and ALK positive NSCLC, as well as multiple discovery phase research programs. To learn more, visit www.nuvalent.com and follow us on Twitter (@nuvalent) and LinkedIn.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express and implied statements regarding Nuvalent, Inc. (“Nuvalent”, the “Company”, “we” or “our” strategy, business plans and objective; progress and timing of preclinical and clinical development of Nuvalents’ programs, including NVL-520 and NVL-655; launch expectations expected clinical trial of NVL-520, including timeline; expectations for Nuvalent capital use, expenses and other financial results in 2021 and into the future. The words “may”, “could “,” Will “,” could “,” should “,” should “,” expect “,” plan “,” anticipate “,” intend “,” believe “,” ‘wait “, “Estimate”, “seek”, “predict”, “the future”, “project”, “the potential”, “pursue”, ” , although not all forward-looking statements contain these identifying words.

All forward-looking statements contained in this press release are based on the current expectations and beliefs of management and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to occur. differ materially from those expressed or implied by any forward-looking statement. statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on the countries or regions in which the Company operates or operates, as well as on the schedule and schedule and anticipated results of its future trials, strategy and operations, including the planned launch of Phase 1 of a global Phase 1/2 clinical trial for NVL-520, the schedule and the progress of studies enabling the IND of NVL-655 and the progress of the Company’s discovery -stage programs; the Company’s expectations regarding additions to its management and board of directors; the Company’s ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and results of Nuvalent’s planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in more detail in the section entitled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended. June 30, 2021, as well as any subsequent filing with the Securities and Exchange Commission. In addition, forward-looking statements represent the views of Nuvalent only to date and should not be construed as representing our views at any later date. Nuvalent expressly disclaims any obligation to update any forward-looking statements. No representation or warranty (express or implied) is made as to the accuracy of these forward-looking statements.

INCOME STATEMENTS AND GLOBAL LOSS STATEMENTS

(In thousands, excluding data per share and per share)

(Unaudited)

Three months ended in June 30,

Six months ended in June 30,

2021

2020

2021

2020

Operating costs :

Research and development

$

7,826

$

3,657

$

13.310

$

6,983

general and administrative

2,024

349

2 702

668

Total operating expenses

9,850

4,006

16,012

7 651

Operating loss

(9,850)

(4,006)

(16,012)

(7 651)

Other income (expenses):

Change in fair value of preferred securities

share tranche rights

(4,542)

(635)

4,471

Other income (expenses), net

12

(9)

24

(18)

Total other income (expense), net

12

(4,551)

(611)

4,453

Net loss and aggregate loss

$

(9 838)

$

(8.557)

$

(16 623)

$

(3 198)

Net loss per share attributable to

ordinary, basic and

diluted

$

(3.17)

$

(2.82)

$

(5.37)

$

(1.20)

Weighted average of common shares

stock in circulation, basic and diluted

3 106 152

3,037,974

3,095,639

2,675,827

SELECTED BALANCE SHEET DATA

(In thousands)

(Unaudited)

June 30,

December 31,

2021

2020

Cash

$

138,919

$

10 332

Working capital

$

133,452

$

6 266

Total assets

$

143,502

$

10 646

Total responsibilities

$

5,829

$

6 615

Total shareholder deficit

$

(47,740)

$

(31 323)

Cision

Cision

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SOURCE Nuvalent, Inc.



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