On November 10, 2022 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported financial results for the third quarter ended September 30, 2022 and provided a business update (Press release, Kezar Life Sciences, NOV 10, 2022, View Source [SID1234623713]).

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"In the third quarter, the team at Kezar continued its tradition of strong execution across our clinical and portfolio development plans," said John Fowler, Kezar’s Co-founder and Chief Executive Officer. "Supported by the results from the MISSION study, our conviction remains high that zetomipzomib has the potential to be a non-immunosuppressive, steroid-sparing treatment for patients with lupus and lupus nephritis. In addition, our recently announced development plan in autoimmune hepatitis underscores our belief that zetomipzomib can help patients across a diverse range of autoimmune diseases. In parallel, we are excited by progress in our protein secretion inhibition platform and look forward to our SITC (Free SITC Whitepaper) poster presentation tomorrow on KZR-540, an oral small molecule that selectively blocks PD-1 expression."

Zetomipzomib: Selective Immunoproteasome Inhibitor

MISSION – Phase 2 clinical trial of zetomipzomib in patients with active lupus nephritis (LN) (NCT03393013)

Kezar presented positive complete results for the 37-week Phase 2 MISSION clinical trial at the American Society of Nephrology’s (ASN) Kidney Week 2022 Annual Meeting.
During the 24-week treatment period, patients received 60 mg of zetomipzomib subcutaneously once weekly (first dose of 30 mg) in addition to stable background therapy. End-of-treatment assessments occurred at Week 25 (EOT), with a safety follow up period and completion of the study at Week 37 (EOS). Patients in the MISSION Phase 2 clinical trial received zetomipzomib without induction therapy, which represents a difference from other recently published clinical trials in LN. The primary efficacy endpoint for the trial was the proportion of patients achieving an overall renal response (ORR), measured as a 50% or greater reduction in urine protein to creatinine ratio (UPCR) at end-of-treatment. A key secondary efficacy endpoint was the number of patients with a complete renal response (CRR), measured as an absolute reduction in proteinuria values to a UPCR of 0.5 or less, with preserved renal function (eGFR), and corticosteroid use of 10 mg or less prednisone/prednisone equivalent and no use of prohibited medication.
In the MISSION Phase 2 clinical trial, 17 of 21 enrolled patients reached end-of-treatment at Week 25 and end-of-study at Week 37:
ORRs were achieved in 11 of 17 patients (64.7%) at EOT. This benefit occurred with a 53% mean reduction of background corticosteroid use.
During the safety follow up period, clinical responses deepened, and ORRs increased to 16 patients (94.1%) at Week 29 and 15 patients (88.2%) at EOS. Of these responders, 12 patients (70.6%) also reached a UPCR of 0.7 or less at EOS.
CRRs were achieved in 6 of 17 patients (35.3%) at EOT, including a UPCR of 0.5 or less, stable eGFR, daily prednisone/prednisone equivalent dose of 10 mg or less, and no use of prohibited medication.
During the safety follow up period, an additional patient achieved a CRR, with the total CRRs increasing to 7 patients (41.2%) at both Week 29 and EOS.
Key measurements of SLE disease activity were reduced and key biomarkers of SLE improved. There was no evidence of early rebound of inflammation following discontinuation of zetomipzomib.
Kezar will also present the complete MISSION data set at the upcoming American College of Rheumatology (ACR) Convergence 2022, which is taking place November 10 – 14, 2022 in Philadelphia, PA. The ACR poster presentation details are available here.
PORTOLA – Phase 2 clinical trial of zetomipzomib in patients with autoimmune hepatitis (AIH) who have not benefited from standard-of-care treatment (NCT05569759)

In October 2022, Kezar received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration for zetomipzomib for the treatment of AIH. AIH is a rare, chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients’ physical health and quality of life.
The PORTOLA trial (KZR-616-208) is a randomized, double-blind, placebo-controlled Phase 2a clinical trial evaluating the safety and efficacy of zetomipzomib in patients with AIH that are insufficiently responding to standard of care or have relapsed. The target enrollment will be 24 patients, who will be randomly assigned (2:1) to receive either zetomipzomib or placebo in addition to background corticosteroid therapy for 24 weeks and includes a protocol-mandated steroid taper by Week 14. The primary efficacy endpoint will measure the proportion of patients who achieve a complete response measured as normalization of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels with a successful corticosteroid taper by Week 24.
Protein Secretion Inhibition

KZR-261-101 – Phase 1 clinical trial of KZR-261 in patients with locally advanced or metastatic solid malignancies (NCT05047536)

KZR-261 is a novel, broad-spectrum agent that acts through direct interaction and inhibition of the Sec61 translocon. In preclinical studies, KZR-261 has been shown to induce a direct anti-tumor effect as well as modulate the tumor microenvironment, including enhancing anti-tumor immune responses.
The Phase 1 clinical trial of KZR-261 is being conducted in two parts: dose escalation, and dose expansion in subjects with selected tumor types. The trial is designed to evaluate safety and tolerability, pharmacokinetics and pharmacodynamics, as well as to explore the preliminary anti-tumor activity of KZR-261 in patients with locally advanced or metastatic disease.
KZR-540 – Kezar will introduce promising preclinical data on KZR-540, an oral small molecule inhibitor that selectively blocks PD-1 expression via inhibition of the Sec61 translocon, on November 11, 2022 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting in Boston, MA. KZR-540 illustrates that the Sec61 translocon can be selectively inhibited for specific anti-tumor effects and validates Sec61 inhibition as a platform for additional new chemical entities.

Details for the SITC (Free SITC Whitepaper) poster presentation are as follows:
Title: KZR-540 is a novel oral small molecule inhibitor of Sec61 cotranslational translocation that potently and selectively blocks PD-1 expression (#422)
Category: Checkpoint Blockade Therapy
Date/Time: November 11, 2022 from 9 AM – 8:30 PM ET
Presenter: Cristina Delgado-Martin, Senior Scientist, Biology
Financial Results

Cash, cash equivalents and marketable securities totaled $290.4 million as of September 30, 2022, compared to $208.4 million as of December 31, 2021. The increase was primarily attributable to net proceeds from the issuance of common stock under the "at-the-market" Sales Agreement with Cowen and Company, LLC, net of cash used in operations to advance clinical-stage programs and preclinical research and development.
Research and development expenses for the third quarter of 2022 increased by $3.4 million to $13.9 million compared to $10.5 million in the third quarter of 2021. This increase was primarily due to an increase in personnel-related expenses including non-cash stock-based compensation because of headcount growth, and higher research and clinical development expenses, to advance the zetomipzomib clinical programs and the KZR-261 Phase 1 clinical trial.
General and administrative expenses for the third quarter of 2022 increased by $1.0 million to $5.0 million compared to $4.0 million in the third quarter of 2021. The increase was primarily due to an increase in personnel-related expenses including non-cash stock-based compensation.
Net loss for the third quarter of 2022 was $17.8 million, or $0.25 per basic and diluted common share, compared to a net loss of $14.5 million, or $0.28 per basic and diluted common share, for the third quarter of 2021.
Total shares of common stock outstanding were 68.4 million shares as of September 30, 2022. Additionally, there were outstanding pre-funded warrants to purchase 3.8 million shares of common stock at an exercise price of $0.001 per share, 0.4 million outstanding restricted stock units and options to purchase 9.6 million shares of common stock at a weighted-average exercise price of $8.12 per share as of September 30, 2022.

On November 10, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA) , a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported that financial results for the quarter ended September 30, 2022 (Press release, Panbela Therapeutics, NOV 10, 2022, View Source [SID1234623712]). Management is hosting an earnings conference call today at 4:30 p.m. ET.

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The third quarter was marked by meaningful progress.

Q3 and early Q4 Highlights:

First Patient Enrolled in the company’s Aspire Trial, Panbela’s clinical trial in the first-line treatment of metastatic pancreatic cancer.
Announced Regulatory approval for the opening of Aspire Trial sites in Spain, France and Italy.
Received approval from the Australian Human Research Ethics Committee (HREC) to expand the Aspire Trial to Australia.
Poster presentation highlighting the results for ivospemin (SBP-101) as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April 2022.
Completed registered public offering totaling gross proceeds of $6 Million.
"During Q3 we advanced our pipeline, which is largely funded through partnerships and targets an approximate $5 billion total addressable market," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "Milestones achieved included first patient enrolled in our Aspire global trial for metastatic pancreatic cancer, approval to expand the trial into Australia and approval to open sites in Spain, France and Italy. Through our acquisition of Cancer Prevention Pharmaceuticals (CPP) and organic operational advancements, we have programs spanning pre-clinical to registration studies, including a lead asset with a fully funded registration trial scheduled to begin mid- 2023. Additionally, we bolstered our balance sheet with gross proceeds from a public offering of approximately $6.0 million. In 2023, we anticipate a consistent stream of milestones to drive shareholder value."

During Q4 2022, we expect the initiation of a Phase I/II program in STK11 mutant non-small cell lung cancer which will be our first clinical proof of concept study evaluating polyamine modulation to improve anti-PD-1 efficacy.

Looking ahead to early 2023, we expect to announce the final data from our Phase I untreated metastatic pancreatic cancer study as well as the Phase I data from the recent onset type I diabetes program. We will also be opening a neoadjuvant pancreatic cancer investigator-initiated trial with ivospemin (SBP-101) and a Phase II study in recent onset type I diabetes which is supported by Indiana University and the Juvenile Diabetes Research Foundation (JDRF).

Third quarter ended September 30, 2022 Financial Results

General and administrative expenses were $1.3 million in the third quarter of 2022, compared to $0.9 million in the third quarter of 2021. The change is due to slightly higher professional services cost as the Company continues to integrate CPP into its operations.

Research and development expenses were $2.3 million in the third quarter of 2022 compared to $1.3 million in the third quarter of 2021. The increase relates to an increase in spending on our clinical studies.

Net loss in the third quarter of 2022 was $4.4 million, or $0.21per diluted share, compared to a net loss of $2.1 million, or $0.16 per diluted share, in the third quarter of 2021.

Total cash was $0.9 million as of September 30, 2022. Total current assets were $1.8million and current liabilities were $8.0 million as of the same date. Also at September 30, 2022, total noncurrent assets, consisting of cash deposits held by our contract research organization, were $3.1million. Notes payable, plus accrued interest, on the balance sheet, the result of the acquisition of CPP, totaled approximately $7.0 million. The current portion of the notes payable plus accrued interest totaled approximately $1.8 million.

Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

About our Pipeline

The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of news flow with programs ranging from pre-clinical to registration studies.

SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months which is final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source

Flynpovi

Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism of action inhibiting polyamine synthesis and increasing polyamine export and catabolism. In a Phase III clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. In our Phase III trial focusing on FAP patients with lower gastrointestinal tract anatomy (patients with an intact colon, retained rectum or surgical pouch) comparing Flynpovi to single agent eflornithine and single agent sulindac, Flynpovi showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI group for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

CPP-1X

CPP-1X (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase I or Phase II investigator-initiated trials suggest that CPP-1X treatment is well tolerated and has potential activity.

On November 10, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a clinical-stage precision oncology company, reported financial results for the quarter ended September 30, 2022, and recent corporate updates (Press release, Kinnate Biopharma, NOV 10, 2022, View Source [SID1234623711]).

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"We continue to make advances with our proprietary programs, and are encouraged by what we’re seeing thus far in the ongoing dose escalation for KIN-2787 monotherapy, our pan-RAF inhibitor," said Nima Farzan, chief executive officer, Kinnate Biopharma Inc. "We are actively investigating multiple targets as part of the Kinnate Discovery Engine and look forward to having a third program enter the clinic next year. We remain well funded to continue to innovate and progress our pipeline of novel small molecule drug candidates."

Pipeline Updates

Announced an update from the ongoing dose escalation for KIN-2787 monotherapy in the global Phase 1 clinical trial, KN-8701. Detailed dose escalation data is expected in the first half of 2023. (View Release)
Subsequent to the KIN-2787 data release, the company anticipates disclosing its next program from the Kinnate Discovery Engine, which is expected to enter the clinic in 2023.
Announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for KIN-2787 for treatment of patients with BRAF Class II or III alteration-positive and/or NRAS mutation-positive stage IIb to IV malignant melanoma that is metastatic or unresectable. (View Release)
Corporate Highlights

Expanded the organization to 86 full-time employees as of September 30, 2022, of which 64 were engaged in research and development activities.
Third Quarter 2022 Financial Results

Cash and Cash Equivalents and Investments Position: As of September 30, 2022, the total of cash and cash equivalents and investments was $262.1 million, excluding cash from its China joint venture, Kinnjiu, and is expected to fund current operations into mid-2024.
Research and Development Expenses: Third quarter research and development expenses for 2022 were $23.5 million, compared to $18.7 million for the same period in 2021.
General and Administrative Expenses: Third quarter general and administrative expenses for 2022 were $7.8 million, compared to $6.1 million for the same period in 2021.
Net Loss: Third quarter net loss for 2022 was $30.7 million, compared to $24.7 million for the same period in 2021.

On November 10, 2022 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported the publication of data in The Lancet Haematology, which summarizes the Phase 1 results of the Phase 1/2 study of olutasidenib, an investigational, oral, small molecule inhibitor of mutant isocitrate dehydrogenase-1 (mIDH1) (Press release, Rigel, NOV 10, 2022, View Source [SID1234623710]). Olutasidenib was assessed as a monotherapy or in combination with azacitidine, in patients with mIDH1 acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The published data suggest that olutasidenib, with or without azacitidine, was well-tolerated and was associated with improvements in clinical efficacy endpoints in patients with mIDH1 AML.

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"These data from the first phase of the Phase 1/2 study suggest that olutasidenib may be both efficacious and well-tolerated, findings that are reinforced by the subsequently reported data from the Phase 2 registrational trial, which generated compelling efficacy and safety data that highlight olutasidenib as a potential treatment option for mIDH1 relapsed/refractory AML," said Wolfgang Dummer, M.D., Ph.D., Rigel’s chief medical officer. "The NDA for olutasidenib, submitted by Forma Therapeutics, is under FDA review and we look forward to a potential approval in early 2023."

The objectives of the first phase of the multi-center, open-label Phase 1/2 study were to assess the safety, pharmacokinetic and pharmacodynamic profile, and clinical activity of olutasidenib, both as monotherapy and in combination with azacitidine, in patients with treatment-naïve or relapsed/refractory (R/R) AML or MDS harboring IDH1 mutations.

Key findings from the study are summarized below:

Among patients receiving combination therapy, treatment-naïve AML patients saw a 77% overall response rate (ORR) and a 54% complete response (CR) plus CR with partial hematological recovery (CR/CRh). These results provide strong rationale for future evaluation of either sequential or triplet therapy in this setting.
In the MDS cohort, 4 of 9 responding patients achieved mutation clearance. CRs were observed with both monotherapy and combination therapy, including an 86% ORR and 57% CR rate in the combination arm. The investigators noted, "To our knowledge, we also report the first available data on patients with myelodysplastic syndrome treated with an IDH1 inhibitor plus azacitidine, where we observed a strong preliminary activity signal."
Olutasidenib was well-tolerated in patients with AML and MDS, either as monotherapy or in combination with azacitidine. No dose limiting toxicities occurred in the dose escalation cohorts. Overall, adverse events were similar and manageable across the monotherapy and combination arms. Transient QT prolongation was observed in 3 patients (4%).
This study showed that olutasidenib has the potential to provide an additional treatment option for mIDH1 AML.
A link to the online publication at The Lancet Haematology can be found here.

Last week, Rigel announced updated interim data from the Phase 2 pivotal cohort of this trial. This data will be presented in a poster at the 64th ASH (Free ASH Whitepaper) Meeting in New Orleans on December 11, 2022. A link to the press release can be found here.

On August 2, 2022, Rigel and Forma Therapeutics, Inc. announced they entered into an exclusive, worldwide license agreement to develop, manufacture and commercialize olutasidenib for the treatment of relapsed/refractory AML (R/R AML) and other malignancies. Forma’s New Drug Application (NDA) for olutasidenib is currently under review by the U.S. Food and Drug Administration (FDA) and the Prescription Drug User Fee Act (PDUFA) target action date is February 15, 2023.

About Olutasidenib and AML
Olutasidenib is an oral, small molecule investigational agent designed to selectively bind to and inhibit mutated IDH1 enzymes. This targeted treatment has the potential to provide therapeutic benefit by reducing 2-HG levels and restoring normal cellular differentiation. IDH1 is a natural enzyme that is part of the normal metabolism of all cells. When mutated, IDH1 activity can promote blood malignancies and solid tumors. IDH1 mutations are present in 6 to 9 percent of patients with AML1.

AML is a rapidly progressing cancer of the bone marrow and blood2. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that in the United States, there will be about 20,050 new cases of AML in 2022, mostly in adults.3 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.

On November 10, 2022 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported financial results for the quarter ended September 30, 2022 and provided a corporate update (Press release, Vincerx Pharma, NOV 10, 2022, View Source [SID1234623709]).

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"We continue progressing our lead clinical candidate, enitociclib, in prioritized indications in double-hit diffuse large B-cell lymphoma (DH-DLBCL), Richter syndrome and high-risk chronic lymphocytic leukemia (CLL). The recent Orphan Drug Designation for enitociclib further strengthens our program by offering important clinical development and commercialization benefits," said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx.

"We are on track to submit our IND for our first-in-class small molecule drug conjugate (SMDC) VIP236 this year and continue to advance our first-in-class and potential best-in-class antibody-drug conjugate (ADC) VIP943 through IND-enabling studies and toward a targeted IND submission in the second half of 2023. Despite the challenging market environment, we are committed to executing across multiple programs and are motivated to strategically move towards achieving our goals of improving outcomes for patients while thoughtfully managing our cash resources."

RECENT CORPORATE HIGHLIGHTS

Orphan Drug Designation granted by the U.S. Food and Drug Administration (FDA) for the Company’s lead candidate, enitociclib (aka VIP152), a positive transcription elongation factor b (P-TEFb)/CDK9 inhibitor, for the treatment of high-grade B-cell lymphoma characterized by translocations of MYC and BCL2 (aka DH-DLBCL) Continued focus on prioritized enitociclib clinical studies:
Monotherapy (NCT02635672) and combination (NCT05371054) in patients with DH-DLBCL
Monotherapy (NCT04978779) in patients with high-risk CLL and Richter syndrome (RS)
Based on discussions with the FDA, combination with Bruton tyrosine kinase (BTK) inhibitor in patients with high-risk CLL (NCT04978779) will start after assessing the safety of enitociclib monotherapy in patients with CLL and RS. Anticipated start of the combination study is early 2023
Targeting initiation of Phase 2 studies in prioritized enitociclib indications in 2023
Enitociclib assigned by United States Adopted Name Council
Continue to implement cost reduction measures including focusing enitociclib studies on key U.S. sites with active patients
Advancement of first-in-class and potentially best-in-class bioconjugation assets continues to be prioritized:
IND submission for SMDC VIP236 on track by year end
IND filing for ADCs, VIP943 and VIP924, on track for 2H2023 and 1H2024, respectively
Upcoming poster presentations at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2022
Poster titled "VIP943 Is a Novel CD123 Antibody Drug Conjugate with In Vitro and In Vivo Efficacy in Acute Myeloid Leukemia (AML) Models"
Poster titled "Enitociclib (VIP152/formerly BAY1251152) Is a Selective and Active CDK9 Inhibitor: Preliminary Safety and Early Signs of Efficacy in Patients with Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)"
Poster titled "Preclinical Study of Enitociclib, a Selective CDK9 Inhibitor, in Combination with Bortezomib, Lenalidomide, Pomalidomide, or Venetoclax in the Treatment of Multiple Myeloma"
Received one-year extension of Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency’s (EMA) Micro, Small and Medium-Sized Enterprise, enabling Vincerx to become eligible for EMA fee reductions and waiver and other financial incentives
THIRD QUARTER 2022 FINANCIAL RESULTS

Vincerx Pharma had approximately $66.0 million in cash, cash equivalents and marketable securities as of September 30, 2022, as compared to approximately $111.5 million as of December 31, 2021. Based on its current business plans and assumptions, Vincerx believes its available cash will be sufficient to meet its operating requirements into late 2024.
Research and development expenses for the quarter ended September 30, 2022 were approximately $11.1 million, as compared to approximately $12.2 million for the same period in 2021. This decrease is the result of a decline in stock-based compensation expense of approximately $3.1 million. Excluding stock-based compensation expense, research and development expenses increased by approximately $2.0 million for the quarter ended September 30, 2022 compared to the quarter ended September 30, 2021, primarily due to an increase in manufacturing services associated with Vincerx’s ADC programs. Research and development expenses for the nine months ended September 30, 2022 were approximately $40.8 million, as compared to approximately $27.7 million for the same period in 2021. This increase for the nine months ended September 30, 2022 compared to the same period in 2021 primarily relates to increases in manufacturing services of approximately $6.6 million, including the initiation of manufacturing associated with Vincerx’s ADC programs, third party research and preclinical work of approximately $5.4 million, new employee salaries of approximately $2.6 million and clinical services of approximately $1.0 million, partially offset by a decline in stock-based compensation expense of approximately $4.5 million.
General and administrative expenses for the three and nine months ended September 30, 2022 were approximately $4.5 million and $14.9 million, respectively, as compared to approximately $5.7 million and $17.2 million for the same periods in 2021, respectively. These decreases were primarily the result of declines in stock-based compensation expense of approximately $1.2 million and $2.5 million for the three- and nine-month periods, respectively.
For the quarter ended September 30, 2022, Vincerx reported a net loss of approximately $16.9 million, or $0.80 per share, as compared to a net loss of approximately $24.5 million, or $1.39 per share, for the same period in 2021. The net loss for the quarter ended September 30, 2021 includes a loss from the change in fair value of our warrant liabilities of approximately $6.6 million, as compared to a loss of approximately $0.1 million for the same period in 2022. For the nine months ended September 30, 2022, Vincerx reported a net loss of approximately $51.7 million, or $2.46 per share, as compared to a net loss of approximately $32.8 million, or $2.06 per share, for the same period in 2021. The net loss for the nine months ended September 30, 2021 includes a gain from the change in fair value of our warrant liabilities of approximately $12.1 million, as compared to a gain of approximately $6.3 million for the same period in 2022.