On November 14, 2023 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, reported financial results for the third quarter ended September 30, 2023 (Press release, Renovorx, NOV 14, 2023, View Source [SID1234637638]).

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"We remain focused on our core mission to improve the lives of patients diagnosed with difficult-to-treat cancers by delivering novel targeted combination therapies that have the potential to alter the current paradigm of oncology care," said Shaun Bagai, CEO of RenovoRx. "We are encouraged by the progress in our pivotal Phase III TIGeR-PaC study, and the recent completed interim analysis, along with our partnership with Imugene as we explore pipeline expansion opportunities using our TAMP therapy platform."

Key Business Highlights:

● Continued to advance Phase III TIGeR-PaC clinical trial for the treatment of LAPC. The first of two interim analyses was completed in March 2023, and the Data Monitoring Committee recommended a continuation of the study. The study is prespecified to provide a primary endpoint of a 6-month OS benefit and secondary endpoints including reduced adverse events versus standard of care. Additionally, Dr. Michael J. Pishvaian, Johns Hopkins Medicine and Principal Investigator of TIGeR-PaC, presented at the Global Summit on Gastrointestinal Malignancies in Bermuda. The presentation, "Increasing Local Gemcitabine Delivery Using TAMP in the Chemotherapy Advances in Pancreatic Cancer," highlighted the proprietary TAMP therapy platform and its design to ensure precise delivery for targeted treatment of cancer, and its potential for increased safety, tolerance, and improved efficacy.
● Ripal Gandhi, FSIR, FSVM, investigator in the TIGeR-PaC study, presented, "Advances in Pancreatic Cancer: Trans-arterial Therapy on the Horizon," at the Symposium on Clinical Interventional Oncology (CIO) on September 22-24, 2023, in Orlando, Florida. Dr. Gandhi highlighted the TAMP therapy platform as a potential targeted treatment option for patients diagnosed with locally advanced pancreatic cancer versus the standard of care. Dr. Gandhi is a member of the Miami Cancer Institute and Miami Cardiac and Vascular Institute physician team, a Clinical Professor at Florida International University Herbert Wertheim College of Medicine and Associate Professor at USF School of Medicine.
● Collaboration with Imugene Ltd (ASX: IMU) further validates the TAMP platform and will expand use of RenovoRx’s delivery platform beyond chemotherapy to immunotherapy.

Financial Highlights for Third Quarter ended September 30, 2023:

● Cash Position: Cash and cash equivalents as of September 30, 2023, were $3.2 million.
● R&D Expenses: Research and development expenses were $1.6 million for the quarter ended September 30, 2023, compared to $0.8 million for the quarter ended September 30, 2022. The increase was primarily due to our ongoing Phase III clinical trial cost of $0.4 million, an increase in employee and related benefits costs of $0.3 million and general and administrative allocated costs of $0.2 million. This increase was partially offset by a decrease in costs associated with a secondary manufacturer of $0.1 million.
● G&A Expenses: General and administrative expenses were $1.3 million for the third quarter ended September 30, 2023, flat compared to the same period last year. Employee and related benefits costs increased $0.3 million compared to the same quarter last year. This increase was offset by a decrease in directors’ and officers’ insurance expenses of $0.1 million, including allocation of general and administrative expenses to research and development of $0.2 million.
● Net Loss: Net loss was $1.4 million for the quarter ended September 30, 2023, compared to net loss of $2.1 million for the quarter ended September 30, 2022. The decrease is primarily due to an increase in operating expenses of $0.8 million, offset by $1.5 million reported gain on the fair value of common warrants issued under our Registered Direct Offering in April 2023.
● Shares Outstanding: Shares of common stock outstanding, as of September 30, 2023, were 10,693,080.

On November 14, 2023 QSAM Biosciences Inc. (OTCQB: QSAM), a company developing therapeutic radiopharmaceuticals for the treatment of primary and secondary bone cancer and related conditions, reported that it has signed a non-binding term sheet (the "Term Sheet") with Telix Pharmaceuticals (US) Inc., a subsidiary of Telix Pharmaceuticals Limited (ASX: TLX) (collectively, "Telix") providing material terms for the acquisition of the Company by Telix by means of a merger (the "Acquisition"). Upon signing of the Term Sheet, Telix has agreed to pay the Company a US$2 million Pre-Closing Collaboration and Option Fee (the "Collaboration Fee") to advance the Company’s development efforts based on mutually agreed goals and to provide sixty days of exclusivity pending completion of diligence and execution of a definitive acquisition agreement (Press release, QSAM Biosciences, NOV 14, 2023, View Source [SID1234637637]).

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Among the material terms still subject to diligence and definitive agreements, upon closing of the Acquisition, Telix is expected to pay a total of US$33.1 million in Telix stock and up to US$90 million in contingent clinical and commercial milestone payments through a Contingent Value Rights ("CVR") structure. If the Acquisition does not close, the Collaboration Fee will be converted to Company common stock at a price of 6.70 per share.

Dr. C. Richard Piazza, QSAM’s Executive Chairman and co-Founder, stated, "We are thrilled to commence working with Telix by virtue of the Collaboration Fee to advance our technology and pursue a definitive agreement leading to the acquisition of QSAM by Telix. Over the last few months, we have gotten to know Telix’s unique strengths and resources in the radiopharmaceutical space and believe a business combination with them would provide the greatest chances of success for CycloSam and for our shareholders. We will be working diligently to try to get this transaction completed in the first quarter of 2024."

Dr. Christian Behrenbruch, Managing Director and Group CEO of Telix, continued, "We are pleased to announce our intention to acquire QSAM. This acquisition will bring a validated therapeutic candidate with the potential to accelerate development under the Orphan Drug and Rare Pediatric Disease designations, and a highly experienced team that has completed numerous FDA approvals. With CycloSam we plan to leverage Telix’s extensive experience and success in distributing short-life radiopharmaceuticals using a cold kit product from a nuclear pharmacy. Given these factors, we see a strong pathway to commercialization."

The Acquisition is subject to the satisfactory completion of diligence by both parties, execution of definitive agreements, and approval by the QSAM shareholders, among other conditions.

On November 14, 2023 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, reported its financial results for the quarter ended September 30, 2023 (Press release, PDS Biotechnology, NOV 14, 2023, View Source [SID1234637636]). The Company will provide a business update on its conference call and webcast at 8:00 AM EST today.

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CEO Comments:
"We are pleased with the outcome of the National Cancer Institute (NCI)-led Phase 2 triple combination trial of PDS0101, PDS01ADC (formerly known as PDS0301) and an investigational immune checkpoint ihnibitor (ICI). The data show that 75% of immune checkpoint inhibitor (ICI)-naïve patients remain alive at three years, and the 12-month overall survival (OS) rate in the ICI-resistant patients is 72%," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "Furthermore, the triple combination continues to be well tolerated, with only 4% of patients reported to have Grade 4 treatment-related adverse events."

He continued, "As the development of our IL12 fused antibody-drug conjugate or ADC, PDS01ADC, continues to progress, its potential to overcome key safety and efficacy limitations associated with existing cytokine therapy is reinforced. Data presented at Cytokines 2023 marked the first-in-human clinical trial evaluating the combination of docetaxel chemotherapy and PDS01ADC to treat advanced metastatic castration sensitive (mCSPC) and castration resistant prostate cancer (mCRPC). Decreases in prostate-specific antigen (PSA) levels were reported in all patients. In addition, with our lead candidate PDS0101, the interim Phase 2 VERSATILE-002 data presented during our Key Opinion Leader (KOL) roundtable showed a 2-year overall survival rate of 74% in ICI-naïve human papillomavirus (HPV)16- recurrent/metastatic head and neck cancer patients. We are excited about the strides we are making across our pipeline, fueled by our commitment to developing groundbreaking therapies that revolutionize cancer treatments."

Recent Business Highlights:

PDS0101 Lead Drug Candidate

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VERSATILE-003: Received feedback from the U.S. Food and Drug Administration (FDA) regarding the Phase 3 clinical protocol for a randomized, controlled multicenter trial of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with HPV16-positive recurrent and/or metastatic head and neck cancer. PDS Biotech anticipates initiation of VERSATILE-003 in Q1 2024.

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VERSATILE-002: Phase 2 open-label, multicenter clinical trial of PDS0101 in combination with KEYTRUDA in patients with HPV16-positive recurrent and/or metastatic head and neck cancer.

o
Hosted KOL roundtable on interim VERSATILE-002 data and current and future treatments. Highlights from ICI-naïve patients:

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24-month OS rate of 74%; published 24-month OS less than 30% data with approved ICIs for head and neck cancer.2

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Well tolerated with no patients having Grade 4 or 5 combination treatment-related adverse events. Thirteen percent with Grade 3 combination treatment-related adverse events.

o
Presented biomarker data at European Society for Medical Oncology Congress 2023, highlighting that the combination of PDS0101 and KEYTRUDA has the potential to promote a TH1 immune response which is known to promote a strong CD8 T cell response. Biomarker data demonstrated that the combination promotes the induction of HPV16-specific multifunctional CD8 T cells.

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IMMUNOCERV: Phase 2 clinical trial investigating PDS0101 in combination with standard-of-care (SOC) chemoradiotherapy (CRT) in the treatment of locally advanced cervical cancer patients with large tumors over 5 cm in size and/or cancer that has spread to the lymph nodes.

o
Data presented at American Society for Radiation Oncology 2023 Annual Meeting demonstrated PDS0101, in combination with SOC CRT, was associated with a rapid decline in HPV circulating cell-free DNA, a potential predictive biomarker of treatment response. Ninety-two percent reduction in ctDNA with PDS0101 and SOC and 53% reduction was seen with SOC at 5 weeks.

PDS01ADC (formerly known as PDS0301): IL12 Fused Antibody Drug Conjugate

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NCI-led Triple Combination: Phase 2 clinical trial for combination therapy of PDS0101, PDS01ADC and an investigational ICI for the treatment of recurrent/metastatic HPV-positive, ICInaïve and ICI-resistant HPV16-positive cancers including anal, cervical, head and neck, vaginal and vulvar cancers.

o
ICI-naïve group:

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75% of patients remain alive at 36 months; published median OS data in similar patients is 7-11 months.1 The median OS has not yet been reached.

o
ICI-resistant group:

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12-month OS rate of 72%.

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Median OS approximately 20 months; published median OS in HPV-positive ICI-resistant cancer is 3.4 months3.

o
Responses were seen in all HPV-positive tumor types.

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NCI-led PDS01ADC + Docetaxel: Phase 1/2, open-label, single-arm trial of PDS01ADC in combination with docetaxel in advanced mCSPC and mCRPC.

o
Presented interim safety and immune response data of the combination in the first clinical trial of an immunocytokine with docetaxel in prostate cancer patients at Cytokines 2023.

o
Decrease in PSA levels was seen in all patients at all three tested doses of PDS01ADC and 61% of patients had at least a 60% decrease in PSA levels.

■
All doses of the combination were well-tolerated with one patient experiencing Grade 4 neutropenia.

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Presented data from the NCI-led preclinical study evaluating PDS0101, PDS01ADC and an HDAC inhibitor at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 38th Annual Meeting, (demonstrating antitumor activity against ICI-resistant cancers.

PDS0202 Universal Flu Candidate

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Presented data from the preclinical universal flu vaccine program at 9th European Scientific Working Group on Influenza, demonstrating the potential ability of PDS0202 to neutralize multiple influenza viruses. PDS0202 also demonstrated the ability to prevent viral replication in the lungs of ferrets and provide complete protection after challenge with lethal doses of the H1N1 influenza virus.

Third Quarter 2023 Financial Results
Net loss for the three months ended September 30, 2023 was approximately $10.8 million, or $0.35 per basic share and diluted share, compared to a net loss of approximately $7.4 million, or $0.26 per basic and diluted share, for the three months ended September 30, 2022. The higher net loss reported for the three months ended September 30, 2023 is primarily due to the increase in research and development expenses and general and administrative expenses.

Research and development expenses increased to $6.4 million for the three months ended September 30, 2023 from $4.4 million for the three months ended September 30, 2022. The increase of $2.0 million is primarily attributable to an increase of $1.3 million in clinical trials, and $0.7 million in personnel costs, including $0.3 million in non-cash stock-based compensation.

General and administrative expenses increased to $4.1 million for the three months ended September 30, 2023 from $2.9 million for the three months ended September 30, 2022. The increase of $1.2 million is primarily attributable to an increase of $0.7 million in personnel costs, including $0.5 million in non-cash stock-based compensation, and $0.5 million in investor relations costs.

PDS Biotech’s cash balance as of September 30, 2023 was approximately $54.3 million. PDS Biotech believes that, with initiating the VERSATILE-003 Phase 3 clinical trial in the first quarter of 2024, its available cash resources will sustain operational and research and development endeavors into the third quarter of 2024. PDS Biotech expects to execute its current operational and research and development endeavors by obtaining additional capital, principally through entering into collaborations, strategic alliances, or license agreements with third parties and/or additional public or private debt and/or equity financings. The Company has had and continues to provide, what the Company believes to be favorable development milestones to the market and has upcoming development milestones.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM EST today, November 14, 2023. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13741454. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months.

On November 14, 2023 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova" or "the Company"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported third quarter 2023 financial results and provided an update on recent pipeline progress (Press release, Onconova, NOV 14, 2023, View Source [SID1234637635]). Management plans to host a conference call and live webcast at 4:30 p.m. ET today to discuss these results.

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"Onconova has made excellent progress in the third quarter of 2023. Starting with our lead program, narazaciclib, a differentiated inhibitor of multiple kinases including CDK4/6, we advanced the registrational trial preparations in the first indication, for patients with low grade endometrioid endometrial cancer (LGEEC). CDK4/6 inhibitors have substantially changed the face of cancer care for the better and become a multibillion-dollar drug class. We believe narazaciclib has the potential to be differentiated by potently targeting proteins putatively involved in the resistance pathways of cancer cells that the approved agents fail to significantly inhibit," said Steve Fruchtman, M.D., President and Chief Executive Officer.

Dr. Fruchtman continued, "We are seeing clinical and biological target engagement with narazaciclib and an acceptable safety profile at therapeutic dosing levels in the Phase 1/2 program. To date, we have not seen significant neutropenia and thus remain on target to deliver narazaciclib as a daily anti-cancer drug not requiring time off to permit marrow recovery, in contrast to the most commonly prescribed CDK4/6 inhibitor. In addition, to date, narazaciclib has not caused significant diarrhea, another limitation of other CDK4/6 inhibitors. Based on this profile, we have decided to dose escalate to at least one more cohort in each of the ongoing U.S. studies, to ensure that we achieve the optimal recommended Phase 2 dose. This may extend the Phase 1/2 program into the first quarter of 2024. We believe this is very good news for the program because it underscores the potential for narazaciclib to have a differentiated safety profile and wide therapeutic index."

"From a corporate perspective, in the third quarter, we named Dr. Victor Moyo as Chief Medical Officer and Meena Arora as Vice-President, Global Medical Affairs & Research and Development, putting us on very solid footing to advance the clinical plan and regulatory strategy for narazaciclib and rigosertib. In addition, we continue to actively engage in a range of discussions related to partnering opportunities, to support the progression of our programs," continued Dr. Fruchtman. "Finally, we progressed the development of a registrational study plan for rigosertib, our cell pathway inhibitor, for the ultra-rare indication of recessive dystrophic epidermolysis bullosa-associated squamous cell carcinoma (RDEB-associated SCC). These developments were complemented by impressive medical meeting presentations on both programs by our collaborators."

Near Term Narazaciclib Milestones: Onconova intends to:

· present preclinical data at two December medical meetings: the San Antonio Breast Cancer Symposium (SABCS) and the annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper);
· continue the dose escalation segment of the Phase 1/2 program which may bring us into the first quarter of 2024;
· provide a read-out on narazaciclib’s safety and pharmacology in the first half of 2024;
· provide an update on our registrational trial-readiness over the next few quarters, including the definition of our recommended Phase 2 dose, engagement with the FDA on the pivotal trial design, and continuing to work with external clinical experts including the Gynecologic Oncology Group (GOG), and the European Network for Gynecologic Oncology Trials (ENGOT).

Achievement of these milestones will also enable us to establish a solid foundation to expand the program to include other indications such as breast cancer, ovarian cancer, and mantle cell lymphoma.

Rigosertib milestones: Onconova confirms plans to provide an update on the next steps to obtain orphan designation for rigosertib in RDEB-associated SCC and for the registrational program in the first half of 2024.

Second Quarter Financial Results

Cash and cash equivalents as of September 30, 2023, were $25.2 million, compared to $38.8 million as of December 31, 2022. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business into the third quarter of 2024.

Research and development expenses were $2.5 million for the third quarter of 2023, compared with $3.6 million for the second quarter of 2022.

General and administrative expenses were $2.7 million for the third quarter of 2023, compared with $2.1 million for the second quarter of 2022.

Net loss for the third quarter of 2023 was $4.7 million, or $0.23 per share on 21.0 million weighted average shares outstanding, compared with a net loss of $5.4 million, or $0.26 per share for the third quarter of 2022 on 20.9 million weighted average shares outstanding.

Conference Call and Webcast Information

Interested parties who wish to participate in the conference call may do so by dialing:

· (800) 715-9871 for domestic and
· (646) 307-1963 for international callers and
· Using conference ID 3238751

Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the Company’s website at www.onconova.com and clicking on the webcast link. In addition to the live webcast, a replay will be available on the Onconova website for 90 days following the call.

On November 14, 2023 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline progress and reported third quarter 2023 financial results (Press release, Nuvalent, NOV 14, 2023, View Source [SID1234637634]).

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"This has been another incredible year of execution for Nuvalent. With our recent presentation at ANE, we have now delivered preliminary proof-of-concept data for both of our novel parallel lead programs in ROS1 and ALK-positive cancers, and our third development candidate, NVL-330, is advancing toward clinical development," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "This level of achievement in just over five years since first program inception is only made possible by the tireless dedication of our team to our goal of delivering potential new therapies to patients as quickly as possible."

Dr. Porter continued, "As we turn our focus towards execution on our global development plans to support potential NDA submission and continued portfolio expansion, we are committed to maintaining the high standard and sense of urgency we have established to date. We continue to grow our team in support of this next phase of development and are thrilled to welcome Dr. Perrin Wilson, who brings deep expertise in both business development and commercial strategy."

"We are encouraged by the positive reception to our progress and continued support from both new and longstanding stockholders, leading to a successful $300 million public offering," added Alexandra Balcom, Chief Financial Officer at Nuvalent. "With a strong portfolio, proven team, and meaningful cash runway extension expected into 2027, we believe we are well positioned to evaluate opportunities to further accelerate and expand the potential reach of our programs, and to deliver on our mid- and long-term goals."

Recent Pipeline Highlights and Key Anticipated Milestones

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Reported Preliminary Phase 1 Clinical Data from ALKOVE-1 Trial that Support Best-In-Class Potential of NVL-655 for Patients with ALK-Positive NSCLC: Nuvalent recently reported preliminary dose-escalation data from the Phase 1 portion of its ongoing ALKOVE-1 Phase 1/2 clinical trial in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) at the 35th AACR (Free AACR Whitepaper)-NCI-EORTC Symposium in Boston, Massachusetts. Preliminary activity was demonstrated in heavily pre-treated patients with ALK-positive NSCLC, including in subgroups of patients who had likely exhausted all available therapies including lorlatinib, had a history of brain metastases, or had single or compound ALK resistance mutations. Additionally, NVL-655 demonstrated a favorable preliminary safety profile consistent with its ALK-selective, TRK sparing design.

The ALKOVE-1 clinical trial is continuing to enroll patients in the Phase 1 portion of the trial and is focused on further characterizing the safety, pharmacokinetics, and pharmacodynamic profiles, determining the recommended Phase 2 dose (RP2D), and if applicable, the maximum tolerated dose of NVL-655. Upon RP2D selection, the trial is designed to transition directly into the Phase 2 portion, which will evaluate the safety and activity of NVL-655 in several expansion cohorts of patients defined based on the number and type of prior anti-cancer therapies they have received. The Phase 2 cohorts are intended to support potential registration in patients with ALK-positive NSCLC who are both lorlatinib-naïve and lorlatinib-treated.

In addition to the planned Phase 2 cohorts, Nuvalent intends to use these preliminary data in patients with heavily pre-treated ALK-positive NSCLC to guide discussions with physicians that will inform development strategies in TKI-naïve ALK-positive NSCLC.

•
Initiated the Phase 2 Portion of the ARROS-1 Trial of NVL-520 with Registrational Intent for Patients with Advanced ROS1-positive NSCLC:Nuvalent announced the initiation of the Phase 2 portion of ARROS-1 trial following alignment with the US Food and Drug Administration (FDA) on a RP2D of 100 mg daily. The Phase 2 portion of the trial includes potential registrational cohorts for patients with TKI-naïve and TKI-pretreated ROS1-positive NSCLC. The company expects to share updated data from the ARROS-1 trial at a medical meeting in 2024.
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Advancing NVL-330 through IND-enabling Studies: Nuvalent is continuing to advance NVL-330, its novel HER2-selective inhibitor in development for the treatment of HER2 exon 20 insertion-positive cancers, through IND-enabling studies.

Recent Leadership Appointments

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Strengthened Leadership Team with Appointment of Perrin Wilson, Ph.D., as Senior Vice President of Business Development & Strategy:Dr. Wilson brings over 15 years of experience across business development and commercial functions, including leading deals from research stage to company acquisitions and integrations, championing brand strategy and product launches. Before joining Nuvalent, Dr. Wilson held positions of increasing responsibility at Forma Therapeutics/Novo Nordisk, including Head of Forma Business Development and Integration Management Office, Vice President Business Development and Senior Director Global Marketing, Sickle Cell Disease Strategy. During her time at Forma, Dr. Wilson led the Novo Nordisk acquisition and the out-licensing of Forma’s oncology portfolio to three different partners, and was responsible for developing the global brand plan for Forma’s lead molecule and supporting ex-US and lifecycle management strategy. Prior to Forma, Dr. Wilson spent seven years at Takeda in various business development and commercial roles leading several transactions to strengthen Takeda’s oncology pipeline, including the acquisition of ARIAD, and leading the global strategy and pre-launch preparations for Takeda’s myelodysplastic syndromes program. Dr. Wilson received her B.Sc. degree in biology from Lafayette College and a Ph.D. in biomedical sciences from The Rockefeller University.

Financing Highlight

Completed Successful Public Offering of Common Stock Raising $300 Million in Gross Proceeds: On October 19, 2023, Nuvalent closed an underwritten public offering of 5,357,143 shares of Class A common stock at a price to the public of $56.00 per share. The gross proceeds from the offering were approximately $300 million, resulting in net proceeds of approximately $282 million after deducting underwriting discounts, commissions and other offering expenses.

Upcoming Events

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Stifel 2023 Healthcare Conference: Management will be participating in a fireside chat on Wednesday, November 15, 2023, at 12:00 pm ET in New York, NY.
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Piper Sandler 35th Annual Healthcare Conference: Management will be participating in a fireside chat on Wednesday, November 29, 2023, at 1:00 pm ET in New York, NY.

A live webcast of each fireside chat will be available in the Investors section of Nuvalent’s website at www.nuvalent.com, and will be archived for 30 days following the conference.

Third Quarter 2023 Financial Results

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Cash Position & Operating Runway: Cash, cash equivalents and marketable securities were $413.3 million as of September 30, 2023. The company’s cash, cash equivalents and marketable securities as of September 30, 2023, in combination with the net proceeds from the public offering of approximately $282 million, are expected to extend the company’s operating runway into 2027.
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R&D Expenses: Research and development (R&D) expenses were $29.6 million for the third quarter of 2023.
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G&A Expenses: General and administrative (G&A) expenses were $9.2 million for the third quarter of 2023.
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Net Loss: Net loss for the third quarter of 2023 was $33.6 million, or $0.59 per share.