On November 10, 2021 Nuvalent, Inc., (Nasdaq: NUVL), a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported recent pipeline progress and third quarter 2021 financial results (Press release, Nuvalent, NOV 10, 2021, View Source [SID1234595048]).

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"Throughout the third quarter of 2021, we continued to progress our novel portfolio of precisely targeted therapies for patients with cancer. Notably, our first clinical trial of NVL-520, the ‘ARROS-1’ study, is now open for enrollment of patients with advanced ROS1-positive NSCLC and other solid tumors," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We anticipate a robust set of upcoming operational milestones, including the dosing of the first patient in our ARROS-1 study in 2021, the advancement of our parallel lead program NVL-655 into clinical development for ALK-positive cancers, and the expansion of our portfolio with additional internally developed product candidates. With a dedicated, expert team and a strong balance sheet in place, we believe we are well-positioned to achieve the milestones ahead."

Recent Program Highlights

ARROS-1 Phase 1/2 Clinical Trial of NVL-520 Open for Enrollment:
Nuvalent has activated multiple U.S. sites to begin enrollment in its ARROS-1 clinical trial, a Phase 1/2, multicenter, open-label, dose-escalation and expansion study evaluating NVL-520 as an oral monotherapy in patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors. NVL-520 is a novel ROS1-selective inhibitor designed 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 ROS1 tyrosine kinase inhibitors (TKIs). The Phase 2 portion of the ARROS-1 study is designed to support potential registration of NVL-520 in both ROS1-positive patients with NSCLC who are kinase inhibitor-naïve and who have been previously treated with ROS1 kinase inhibitors. Clinical site expansion in the US and EU is ongoing.
Preclinical Data Supporting Lead Programs for ROS1-Positive and ALK-Positive NSCLC Presented at 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference: Nuvalent presented new preclinical data at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference further demonstrating that NVL-520 and NVL-655, its parallel lead product candidates, were active against both wild-type and various known resistance variants of ROS1 or ALK, respectively; were brain-penetrant with the potential to address brain metastases; and selectively inhibited their respective targets compared to the structurally related tropomyosin receptor kinase B (TRKB), thereby minimizing the potential for off-target TRKB-related CNS adverse events. The ARROS-1 Phase 1/2 clinical trial of NVL-520 is open for enrollment, and Nuvalent plans to initiate a Phase 1/2 clinical trial of NVL-655 in advanced ALK-positive NSCLC and other cancers during the first half of 2022.
Upcoming Investor Conference Presentations

33rd Annual Virtual Piper Healthcare Conference: Dr. Porter will participate in a pre-recorded fireside chat during the 33rd Annual Virtual Piper Healthcare Conference, being held November 30 – December 2, 2021. The fireside chat will be available to registered participants beginning on November 22, 2021, and the webcast will be available in the investor section of the company’s website at www.nuvalent.com for 30 days following the presentation.
Third Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $302.4 million as of September 30, 2021, including net proceeds from the initial public offering completed on August 2, 2021, compared to $10.3 million as of December 31, 2020.
Research & Development (R&D) expenses: R&D expenses were $9.1 million for the third quarter of 2021, compared to $3.7 million for the third quarter of 2020.
General & Administrative (G&A) expenses: G&A expenses were $3.4 million for the third quarter of 2021, compared to $0.3 million for the third quarter of 2020.
Net Loss: Net loss for the third quarter of 2021 was $12.4 million, or $0.39 per share, compared to $4.8 million, or $1.57 for the third quarter of 2020.

On November 10, 2021 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that Anna Protopapas, President and Chief Executive Officer, will present a company overview at the Stifel 2021 Virtual Healthcare Conference on Wednesday, November 17, 2021, at 3:20 p.m. ET (Press release, Mersana Therapeutics, NOV 10, 2021, View Source [SID1234595063]).

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A live webcast of the presentation will be available on the Investors & Media section of Mersana’s website at www.mersana.com. An archived replay will be available for approximately 90 days following the event.

On November 10, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, reported that its senior management will present and participate in 1-on-1 meetings with institutional investors at the Jefferies London Healthcare Conference on November 16 and 17, 2021 (Press release, Valneva, NOV 10, 2021, View Source [SID1234595079]).

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Valneva’s Chief Executive Officer Thomas Lingelbach and acting Chief Financial Officer David Lawrence will notably discuss the Company’s late stage vaccine candidates against Lyme disease (VLA15), chikungunya (VLA1553) and COVID-19 (VLA2001).

Valneva recently reported positive Phase 3 results for VLA20011, currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe. The Company also announced last week the closing of a $102.0 million Global Offering2.

Valneva’s presentation will take place on November 16, 2021 at 4:20pm GMT and can be accessed via the following link: View Source To request a meeting at the event, please contact your representative at Jefferies.

On November 10, 2021 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders with high unmet medical need, reported financial results for the third quarter 2021, and provided an update on its clinical programs (Press release, Equillium, NOV 10, 2021, View Source [SID1234595095]).

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"Following positive topline data from the EQUATE study, we started the third quarter by announcing our plans to advance itolizumab into a pivotal clinical study in first-line acute graft-versus-host disease, which we anticipate commencing early in the new year," said Bruce Steel, chief executive officer at Equillium. "Recent strategic activity in the GVHD therapeutic segment demonstrates industry’s recognition of the high unmet medical need for effective treatments for patients suffering from this deadly disease, and we believe our pivotal study could position itolizumab to become the first approved therapy to treat patients with acute GVHD in the first-line setting. We are also encouraged by the reductions in proteinuria observed in the subgroup data from the Type A portion of the EQUALISE study in patients with systemic lupus erythematosus, without lupus nephritis, that had elevated baseline urine protein/creatinine and albumin/creatinine ratios. Based on the Type A data we amended the protocol in the Type B portion to include newly diagnosed patients in addition to refractory patients and selected the 1.6 mg/kg dose. As a result of these protocol enhancements and due to challenges in patient recruitment amid the ongoing global pandemic, we now expect to announce interim data from the Type B portion of the study in patients with lupus nephritis mid-year 2022. We look forward to initiating our pivotal study in first-line acute GVHD early in the new year and presenting topline data from our EQUIP study in moderate to severe asthma before the end of this year."

Corporate & Clinical Highlights Since Beginning of Q3 2021:

Announced plans to initiate a pivotal study in first-line acute graft-versus-host disease (aGVHD) following positive topline results from the EQUATE study and an End-of-Phase 1 meeting with the FDA
Reported additional data from the EQUALISE study’s Type A systemic lupus erythematosus (SLE) patients, without lupus nephritis, that had elevated baseline urine protein/creatinine and albumin/creatinine ratios, demonstrating a mean decrease of 42% and 54%, respectively, at Day 57 following two doses of itolizumab
Presented multiple posters at the American College of Rheumatology (ACR), the American Society of Nephrology (ASN) and the American College of Allergy, Asthma and Immunology (ACAAI)
ASN & ACR
Sustained decrease in proteinuria observed in subgroup of SLE patients, without lupus nephritis, following two doses of itolizumab
Itolizumab was safe and well tolerated at doses ranging from 0.4 to 2.4 mg/kg
Dose dependent decreases in inflammatory marker CD6 following itolizumab administration
ACAAI
◦ Itolizumab was well tolerated in patients with moderate to severe uncontrolled asthma

Upcoming Catalysts:

EQUIP Phase 1b study: topline data in uncontrolled asthma expected Q4 2021
Initiate pivotal study in first-line aGVHD expected early 2022
EQUALISE Phase 1b study: interim data from Type B lupus nephritis patients expected mid-2022
Upcoming Catalysts:

EQUIP Phase 1b study: topline data in uncontrolled asthma expected Q4 2021
Initiate pivotal study in first-line aGVHD expected early 2022
EQUALISE Phase 1b study: interim data from Type B lupus nephritis patients expected mid-2022
Third Quarter 2021 Financial Results

Research and development (R&D) expenses for the third quarter of 2021 were $7.0 million, compared with $4.2 million for the same period in 2020. The increase was driven by greater clinical development expenses related to EQUIP primarily resulting from a lower R&D Tax Incentive benefit from the Australian Taxation Office and by start-up expenses related to our planned pivotal study in aGVHD, partially offset by lower costs related to a Phase 3 COVID-19 clinical trial that we decided not to commence. Greater employee compensation and benefit expenses driven by increased headcount and greater overhead expenses and costs related to our non-clinical research activities also contributed to the increase in R&D expense.

General and administrative (G&A) expenses for the third quarter of 2021 were $2.9 million, compared with $2.3 million for the same period in 2020. The increase was driven by greater employee compensation and benefit expenses primarily related to increased headcount and by greater overhead expenses, partially offset by a decrease in consulting expenses.

Net loss for the third quarter of 2021 was $10.3 million, or $(0.35) per basic and diluted share, compared with a net loss of $6.6 million, or $(0.31) per basic and diluted share for the same period in 2020. The increase in net loss was largely attributable to greater operating expenses.

Cash used in operations for the third quarter of 2021 was $7.0 million compared to $7.0 million in the second quarter of 2021.

Cash, cash equivalents and short-term investments totaled $90.7 million as of September 30, 2021, compared to $97.6 million as of June 30, 2021. Equillium believes that its cash and investments will be sufficient to fund its currently planned operations into 2023.

About Itolizumab

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM signaling pathway to selectively downregulate pathogenic T effector cells while preserving T regulatory cells critical for maintaining a balanced immune response. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

On November 10, 2021 Genenta Science, a clinical-stage biotechnology company pioneering the development of hematopoietic stem progenitor cell immuno-gene therapy for cancer (Temferon), reported that it has filed a registration statement on Form F-1 (the "Registration Statement") with the U.S. Securities and Exchange Commission ("SEC") relating to a proposed initial public offering of the Company’s ordinary shares, to be delivered in the form of American Depositary Shares ("ADSs") (Press release, Genenta Science, NOV 10, 2021, View Source [SID1234595111]). The number and price of the securities to be sold in the offering has not yet been determined.

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The Company has applied to list the ADSs on the Nasdaq Capital Market in the United States under the symbol "GNTA" (file number 333-260923). ADSs are U.S. dollar-denominated negotiable instruments issued by a depositary bank that facilitate U.S. trading and investment in shares of non-U.S. companies. Each ADS represents the right to receive one ordinary share.
Roth Capital Partners is acting as sole book-running manager of the offering. Maxim Group LLC is acting as lead manager of the offering.
The Registration Statement on Form F-1 relating to the proposed sale of these securities has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the Registration Statement becomes effective.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of any securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any potential offering is subject to market and other conditions.

The proposed offering of ADSs will only be made by means of a prospectus. When a copy of the preliminary prospectus relating to the offering is available, copies may be obtained from Roth Capital Partners, 888 San Clemente Drive, Newport Beach, CA 92660, Attention: Equity Capital Markets at (800) 678-9147 or by email at [email protected]; or from Maxim Group LLC at 300 Park Avenue, 16th Floor, New York, NY 10022,