Nuvalent Highlights Execution Across its Novel Kinase Inhibitor Pipeline and Announces Second Quarter 2022 Financial Results

Preliminary dose escalation data expected in the second half of 2022 from the ARROS-1 study of NVL-520 for advanced ROS1 positive NSCLC and other solid tumors

Rapid pipeline progress with ongoing clinical trials for NVL-520 and NVL-655 and two additional development candidates being screened in 2022

CAMBRIDGE, Mass., August 10, 2022 /PRNewswire/ — Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced pipeline progress and second quarter 2022 financial results.

“Our focus for 2022 is the execution of our pipeline of novel kinase inhibitors, and the Nuvalent team has continued to deliver. During the last quarter, we announced our intention to share preliminary dose escalation data at during the second half of 2022 from the phase 1 part of our ARROS-1 phase 1/2 trial for patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) and other solid tumors , and administered the first patient in our Phase 1/2 ALKOVE-1 trial for patients with advanced ALK-positive NSCLC and other solid tumors,” said James Porter, Ph.D., CEO of Nuvalent. “Furthermore, we have continued to advance our discovery pipeline and remain ready to name two additional development candidates by the end of this year – a testament to the strength, ingenuity and efficiency of the he Nuvalent team, our capabilities and our approach is an exciting time for our business, and I am confident in our ability to achieve our goal of precisely targeted therapies that may enable profound and lasting responses for cancer patients.”

Recent Pipeline Accomplishments and Planned Near-Term Milestones

  • Preliminary dose escalation data from the ongoing ARROS-1 trial expected in the second half of 2022: Nuvalent’s Phase 1/2 ARROS-1 clinical trial evaluating NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors is progressing well and continues to enroll patients in Phase 1 of the study. NVL-520 is a selective ROS1 inhibitor designed to address the clinical challenges of emerging treatment resistance, off-target CNS adverse events, and brain metastases that may limit the use of currently available ROS1 kinase inhibitors. The company plans to share preliminary data from the dose escalation portion of the trial in the second half of 2022.
  • Dosing initiation and ongoing enrollment in the ALKOVE-1 trial: Nuvalent is actively dosing patients in the Phase 1 portion of its ALKOVE-1 trial, a Phase 1/2, multicenter, open-label, dose-escalation and expansion trial evaluating NVL-655 in patients with NSCLC ALK -advanced positive and other solid tumors. NVL-655, Nuvalent’s lead parallel product candidate, is a selective ALK inhibitor designed to address the clinical challenges of emerging drug resistance, off-target CNS adverse events and brain metastases that may limit the use of currently available ALK kinase inhibitors.
  • New NVL-655 preclinical data presented at the 2022 IASLC Global Lung Cancer Conference Annual Meeting: A poster characterizing NVL-655 alongside other ALK inhibitors in a patient-derived model of lorlatinib-resistant ALK-positive NSCLC with the treatment-emergent compound resistance G1202R/T1151M mutation was presented at the conference. IASLC 2022 Annual Lung Cancer (WCLC) Meeting. The preclinical activity of NVL-655, as depicted in the featured poster, continues to support the potential for a top notch profile.
  • On track to select two additional development candidates from Discovery Pipeline in 2022: Nuvalent continues to advance its pipeline expansion efforts with several discovery-stage research programs. The Company expects to select development candidates for its programs focused on ALK IXDN compound resistance mutations and HER2 Exon 20 insertions in the second half of 2022.

Second quarter 2022 financial results

  • Treasury : Cash, cash equivalents and marketable securities were $257.0 million as of June 30, 2022. Nuvalent continues to expect that existing cash and cash equivalents will be sufficient to fund its planned operations. until 2024.
  • R&D expenses: Research and development (R&D) expenses were $13.6 million for the second quarter of 2022.
  • General and administrative costs: General and administrative (G&A) expenses were $5.2 million for the second quarter of 2022.
  • Net loss: Net loss for the second quarter of 2022 was $18.5 million, or $0.38 per share.

About Nuvalent

Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage 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 robust pipeline with leading parallel programs in ROS1-positive and ALK-positive non-small cell lung cancer (NSCLC), as well as several discovery-stage research programs. We regularly post information that may be important to investors on our website at www.nuvalent.com. 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, implied and express statements regarding strategy, business plans and orientation of Nuvalent; clinical development programs for resistance mutations to compounds NVL-520, NVL-655, ALK IXDN and HER2 Exon 20 insertions and their timing; the potential clinical effect of NVL-520 and NVL-655; the design and recruitment of the ARROS-1 and ALKOVE-1 studies and their schedule; the potential of Nuvalent’s pipeline programs, including NVL-520 and NVL-655; Nuvalent’s research and development programs for the treatment of cancer; risks and uncertainties associated with drug development; and the distribution of capital. The words “may”, “could”, “will”, “could”, “should”, “should”, “expect”, “plan”, “anticipate”, “aim”, “goal”, ” intends to”, “believe”, “expect”, “estimate”, “seek”, “predict”, “future”, “project”, “potential”, “continue”, “target”, or the negative of these terms and similar words or phrases are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Drug development and commercialization involves a high degree of risk, and only a small number of research and development programs lead to commercialization of a product. You should not place undue reliance on these statements or the scientific data presented.

All forward-looking statements contained in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and factors that may cause actual events or results to differ. differ materially from those expressed or implied by any forward-looking statement. the forward-looking statements contained in this press release, including, without limitation: the risks that Nuvalent may not be able to fully enroll the ARROS-1 or ALKOVE-1 studies or that enrollment may take longer than expected; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; the occurrence of adverse safety events; risks of unexpected costs, delays or other unforeseen obstacles; the risks that Nuvalent may not be able to offer drug candidates from its HER2 Exon 20 and ALK IXDN programs; the direct or indirect impact of COVID-19 or other global geopolitical circumstances on the timing and timing and anticipated results of Nuvalent’s clinical trials, strategy and future operations, including the ARROS-1 and ALKOVE studies -1; the timing and outcome of Nuvalent’s anticipated interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section titled “Risk Factors” of the Company’s Annual Report on Form 10-K for the fiscal year ended. December 31, 2021, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Nuvalent’s views only as of this date and should not be relied upon as representing its views as of any subsequent date. Nuvalent expressly disclaims any obligation to update forward-looking statements.

SELECTED DATA FROM THE INCOME STATEMENT


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


(Unaudited)



















Quarter ended June 30



Semester ended June 30




2022



2021



2022



2021


Operating costs :

















Research and development


$

13,558



$

7,826



$

26,251



$

13,310


general and administrative



5,175




2,024




10,170




2,702


Total operating expenses



18,733




9,850




36,421




16,012


Operating loss



(18,733)




(9,850)




(36,421)




(16,012)


Other income (expenses):

















Change in fair value of preferred shares

slice rights












(635)


Other income, net



267




12




406




24


Total other income (expenses), net



267




12




406




(611)


Net loss


$

(18,466)



$

(9,838)



$

(36,015)



$

(16,623)


Net loss per share attributable to

ordinary shareholders, basic and diluted


$

(0.38)



$

(3.17)



$

(0.75)



$

(5.37)


Weighted average of common shares

exceptional, basic and diluted



48,319,067




3,106,152




48 302 017




3,095,639


SELECTED BALANCE DATA


(In thousands)


(Unaudited)













June 30th,



The 31st of December,




2022



2021


Cash, cash equivalents and marketable securities


$

256,964



$

288 111


Working capital


$

248,786



$

281,841


Total assets


$

263,021



$

293,824


Total responsibilities


$

10,036



$

8,787


Full shareholder equity


$

252,985



$

285,037


SOURCE Nuvalent, Inc.

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