Kintara Therapeutics Announces Fiscal 2023 Second Quarter Financial Results and Provides Corporate Update

On February 14, 2023 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported financial results for its fiscal second quarter ended December 31, 2022 and provided a corporate update (Press release, Kintara Therapeutics, FEB 14, 2023, View Source [SID1234627174]).

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RECENT CORPORATE DEVELOPMENTS

Announced that Kintara had received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for VAL-083 for the treatment of diffuse intrinsic pontine glioma, a rare and highly aggressive childhood brain cancer (December).

Received formal notice from The Nasdaq Stock Market LLC stating that Kintara had regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market LLC ("Nasdaq") (November).

Announced that the FDA had granted Fast Track Designation for Kintara’s REM-001 therapy, which consists of three parts, the laser light source, the light delivery device, and the REM-001 drug product, for the treatment of patients with cutaneous metastatic breast cancer (CMBC) (November).

Completed a 1-for-50 reverse stock split of the Company’s outstanding and authorized common stock, which began trading on a reverse stock split-adjusted basis on Nasdaq on November 14, 2022 (November).

Announced that the REM-001 program in CMBC was paused to conserve cash which will be used to support the funding of the Company’s ongoing international registrational study for VAL-083 in glioblastoma (GBM). By pausing the REM-001 program, Kintara expects to save approximately $3.0 million through calendar 2023 (October).
"While we continue to look for ways to restart our REM-001 program in cutaneous metastatic breast cancer without reducing our cash runway, we are encouraged by the recent progress of our lead asset in brain cancer, VAL-083, and look forward to announcing top-line data in the international registrational GBM AGILE Study before the end of calendar 2023," commented Robert E. Hoffman, Kintara’s President and Chief Executive Officer. "There has been a significant lack of progress in the development of treatments for GBM in the last decades so we are devoted to advancing our novel brain-penetrant small molecule chemotherapy agent, VAL-083, closer to patients and physicians in dire need of new treatment options for this devastating disease."

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2023 SECOND QUARTER ENDED DECEMBER 31, 2022

As of December 31, 2022, Kintara had cash and cash equivalents of approximately $4.9 million.

For the three months ended December 31, 2022, Kintara reported a net loss of approximately $3.5 million, or $2.10 per share, compared to a net loss of approximately $5.9 million, or $6.07 per share, for the three months ended December 31, 2021. For the six months ended December 31, 2022, Kintara reported a net loss of approximately $8.1 million, or $5.42 per share, compared

to a net loss of approximately $11.9 million, or $17.30 per share, for the six months ended December 31, 2021. The decreased net losses for the three and six months ended December 31, 2022 compared to the three and six months ended December 31, 2021 was largely due lower research and development expenses as well as lower general and administrative costs.

Kinnate Biopharma Inc. Receives Fast Track Designation from the U.S. Food and Drug Administration for KIN-3248, an Investigational Pan-FGFR Inhibitor

On February 14, 2023 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a clinical-stage precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Kinnate’s investigational pan-FGFR inhibitor, KIN-3248, for the treatment of patients with unresectable, locally advanced or metastatic cholangiocarcinoma (CCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other alterations, who have received at least one prior systemic therapy (Press release, Kinnate Biopharma, FEB 14, 2023, View Source [SID1234627173]).

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Cholangiocarcinoma, also known as bile duct cancer, is a rare condition, often diagnosed when it is advanced. Research has shown that FGFR is an actionable alteration in patients with CCA. FGFRs are tyrosine kinases that play a crucial role in cell proliferation, differentiation, migration and survival. FGFR2 gene fusions or other alterations are identified in approximately 16% of intrahepatic cholangiocarcinoma (ICC) tumors.

Fast Track is a process designed by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need. A therapeutic candidate that receives Fast Track designation is eligible for more frequent interactions with the FDA to discuss the candidate’s development plan, and if relevant criteria are met, for Accelerated Approval and Priority Review.

About KIN-3248

KIN-3248 is an irreversible, small molecule pan-FGFR inhibitor designed to address primary FGFR2 and FGFR3 oncogenic alterations, including those predicted to drive acquired resistance to current FGFR-targeted therapies, such as gatekeeper, molecular brake, and activation loop mutations observed in cancers such as ICC and urothelial carcinoma (UC). In preclinical studies, KIN-3248 demonstrated inhibitory activity across a wide range of clinically relevant mutations that drive primary disease and acquired resistance to other FGFR inhibitors.

The KN-4802 clinical trial (NCT05242822) is an ongoing multi-center, open-label, two-part study of approximately 120 patients to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of KIN-3248 in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations. In dose escalation (Part A), the trial will determine the recommended dose and schedule of KIN-3248 for further evaluation in patients with FGFR2 and/or FGFR3 gene alteration-driven cancers. Dose expansion (Part B) will assess the safety and efficacy of KIN-3248 at the recommended dose and schedule in FGFR inhibitor naïve and FGFR inhibitor pretreated patients with cancers driven by FGFR2 and/or FGFR3 gene alterations, including ICC, UC, and other advanced or metastatic solid tumors in adults.

This trial is currently enrolling across multiple sites in the U.S. and Taiwan, with additional sites expected globally. Initial dose escalation data is anticipated in the second half of 2023.

The company previously announced that a poster presentation of the design and rationale of the KN-4802 clinical trial will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium. Details are included below.

ASCO Genitourinary Cancers Symposium, February 16-18, 2023

Title: First-in-Human Phase 1/1b Study Evaluating KIN-3248, a Next‑Generation, Irreversible Pan-FGFR Inhibitor, in Patients With Advanced Urothelial Carcinoma and Other Solid Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations
Author: Benjamin Garmezy, MD
Abstract Number: TPS593
Poster Board: P16
Session Type and Track: Trials in Progress Poster Session, Urothelial Carcinoma
Session Date: February 17, 2023, 12:30 p.m. PT / 3:30 p.m. ET

For additional information, visit the ASCO (Free ASCO Whitepaper) Meeting webpage: View Source

Invitae to Announce Fourth Quarter and Full Year 2022 Financial Results on Tuesday, February 28, 2023

On February 14, 2023 Invitae (NYSE: NVTA), a leading medical genetics company, reported that it will report its fourth quarter and full year 2022 financial results on Tuesday, February 28, 2023, and will host a conference call and webcast that day at 4:30 p.m. Eastern / 1:30 p.m (Press release, Invitae, FEB 14, 2023, View Source [SID1234627172]). Pacific to discuss its financial results and recent highlights.

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To access the conference call, please register at the link below:
View Source;confId=46549

Upon registering, each participant will be provided with call details and access codes.

The live webcast of the call and slide deck may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website.

Corcept Therapeutics to Announce Fourth Quarter and Full-Year 2022 Financial Results, Provide Corporate Update and Host Conference Call

On February 14, 2023 MENLO PARK, Calif., Feb. 14, 2023 (GLOBE NEWSWIRE) — Corcept Therapeutics Incorporated (NASDAQ: CORT) reported it will report fourth quarter and full-year 2022 financial results and provide a corporate update on February 28, 2023 (Press release, Corcept Therapeutics, FEB 14, 2023, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announce-fourth-quarter-and-full-year-2022 [SID1234627171]). The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

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Conference Call Information
To access the conference call, please dial 877-407-8029 from the United States or +1-201-689-8029 internationally.

A replay of the call will be available on the Investors / Events tab of www.corcept.com.

BioMarin to Participate Virtually at SVB Securities Global Biopharma Conference on February 16, 2023

On February 14, 2023 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer and Brian Mueller, Executive Vice President, Chief Financial Officer of BioMarin will participate virtually in the SVB Securities Global Biopharma Conference on Thursday, February 16, 2023, at 11:20 a.m. ET (Press release, BioMarin, FEB 14, 2023, View Source,-2023 [SID1234627170]).

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To access the live webcast, please visit: View Source An archived version of the presentation will also be available through the Company’s website for a limited time following the conference.