On August 3, 2022 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported second quarter 2022 financial results and provided a corporate update (Press release, Kura Oncology, AUG 3, 2022, View Source [SID1234617380]).

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"We continue to advance our programs toward a series of important milestones later this year," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "For our menin inhibitor program, we have nearly completed our assessment of patients in the Phase 1b expansion cohorts of our KOMET-001 trial required to identify a recommended Phase 2 dose and remain enthusiastic about the potential for ziftomenib in the treatment of acute leukemias. We look forward to sharing the recommended Phase 2 dose later this year, pending FDA review, along with topline data from the Phase 1b study, followed by a more complete dataset at a medical meeting in the fourth quarter."

"For our farnesyl transferase inhibitor (FTI) program," Dr. Wilson continued, "we are encouraged by the preliminary safety and tolerability of tipifarnib in combination with the PI3Kα inhibitor, alpelisib, as well as early evidence of clinical activity observed in our KURRENT-HN trial. Meanwhile, we remain on track to initiate our KURRENT-LUNG trial of tipifarnib in combination with the EGFR inhibitor, osimertinib, later this quarter and submit an investigational new drug (IND) application for our next-generation FTI, KO-2806, by year end. And we approach these milestones from a position of financial strength, with $450 million in cash and investments that provide runway through 2024."

Recent Highlights

Recommended Phase 2 dose for ziftomenib identified, pending FDA review – In May 2022, Kura announced that it completed enrollment of the 24 patients in the Phase 1b expansion cohorts of the KOMET-001 trial required to identify a recommended Phase 2 dose for ziftomenib. The two Phase 1b expansion cohorts – 200 mg and 600 mg – are each comprised of patients with NPM1-mutant or KMT2A-rearranged relapsed/refractory acute myeloid leukemia (AML). The Company has nearly completed its assessment of the patients for efficacy, safety and tolerability as well as pharmacokinetics and exposure, and believes it has identified a recommended Phase 2 dose for ziftomenib, pending FDA review.

Additional 18 patients enrolled in KOMET-001 trial – Since May 2022, Kura has enrolled an additional 18 patients with NPM1-mutant or KMT2A-rearranged relapsed/refractory AML in the Phase 1b expansion cohorts as the Company prepares to transition into the Phase 2 registration-directed portion of the KOMET-001 trial and initiate a series of combination studies in the relapsed and frontline settings, pending determination of the recommended Phase 2 dose in consultation with the FDA. Kura believes data from all patients treated at the recommended Phase 2 dose will have the potential to contribute to the registrational patient population.

Preliminary activity observed in KURRENT-HN trial of tipifarnib plus alpelisib –Enrollment continues in the Phase 1/2 KURRENT-HN trial of tipifarnib in combination with the PI3Kα inhibitor, alpelisib, in patients with head and neck squamous cell carcinoma (HNSCC). The initial cohort includes patients who have PIK3CA-dependent HNSCC. In addition, the first patient has been dosed in a second cohort of patients with HRAS overexpression. Kura is encouraged by the preliminary safety and tolerability of the combination thus far, as well as early evidence of clinical activity. The Company believes the combination with alpelisib has the potential to increase the total addressable population for tipifarnib to as much as 50% of patients with HNSCC.

KURRENT-LUNG trial of tipifarnib plus osimertinib to initiate this quarter – Kura is preparing to initiate a Phase 1 KURRENT-LUNG trial of tipifarnib in combination with osimertinib in EGFR-mutated non-small cell lung cancer (NSCLC) later this quarter. Preclinical data, generated through a collaboration with INSERM (the French National Institute of Health and Medical Research), support the potential of tipifarnib to prevent emergence of resistance to osimertinib in EGFR-mutant NSCLC. The Company intends to perform initial clinical evaluation with tipifarnib while advancing its next-generation FTI, KO-2806, through IND-enabling studies.
Financial Results

Research and development expenses for the second quarter of 2022 were $24.3 million, compared to $21.1 million for the second quarter of 2021. The increase in R&D expenses was primarily due to increases in clinical trial costs related to the ziftomenib program and personnel costs.

General and administrative expenses for the second quarter of 2022 were $11.1 million, compared to $12.6 million for the second quarter of 2021. The decrease in G&A expenses was primarily due to decreases in personnel costs and professional
fees.

Net loss for the second quarter of 2022 was $34.8 million, compared to a net loss of $33.7 million for the second quarter of 2021.This included non-cash share-based compensation expense of $6.5 million, compared to $6.0 million for the same period in 2021.

Cash, cash equivalents and short-term investments totaled $450.3 million as of June 30, 2022, compared with $518.0 million as of December 31, 2021. Based on its operating plan, management expects that cash, cash equivalents and short-term investments will fund current operations through 2024.
2022 Milestones

Determine the recommended Phase 2 dose for ziftomenib in consultation with the FDA and report topline data from the Phase 1b study later this year.

Present updated data from KOMET-001 at a medical meeting in the fourth quarter.

Initiate the KURRENT-LUNG trial of tipifarnib and osimertinib in the third quarter.

Submit an IND application for KO-2806 in the fourth quarter.
Conference Call and Webcast

Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, August 3, 2022, to discuss the financial results for the second quarter 2022 and to provide a corporate update. The live call may be accessed by dialing (888) 882-4478 for domestic callers and (323) 794-2590 for international callers and entering the conference ID: 8696904. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.

On August 3, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) (Kintara or the Company), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported it has entered into an equity purchase agreement for up to $20 million with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor (Press release, Kintara Therapeutics, AUG 3, 2022, View Source [SID1234617379]).

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Under the terms of and subject to satisfaction of the conditions contained in the agreement, Kintara will have the right in its sole discretion, but not the obligation, to sell to LPC up to $20 million worth of shares of its common stock from time to time over the 36-month term of the agreement. Kintara controls the timing and amount of any future sales of its shares of common stock and LPC is obligated to make purchases in accordance with the terms of the purchase agreement, subject to various limitations contained in the agreement, including those under the Nasdaq listing rules. Any common stock that is sold by Kintara to LPC under the agreement will occur at a purchase price that is based on the market prices prevailing at the time of each sale to LPC. There is no upper limit to the price per share that LPC may pay for future stock issuances under the purchase agreement, and LPC has agreed not to cause or engage in any direct or indirect short selling or hedging of Kintara’s common stock. No warrants are being issued in this transaction and the purchase agreement does not contain any rights of first refusal, participation rights, penalties or liquidated damages provisions in favor of any party. Kintara may terminate the purchase agreement at any time, at its sole discretion, without any cost or penalty.

The Company expects this commitment from LPC will provide financial flexibility and is aligned with Kintara’s long-term strategy for value creation. Kintara intends to use any net proceeds from the sale of its common stock to LPC for working capital and general corporate purposes, including development expenses for VAL-083 and REM-001.

"We are excited to enter into this transaction with Lincoln Park Capital and believe that this agreement provides us an opportunity to access capital in a very efficient manner," said Robert E. Hoffman, President and Chief Executive Officer of Kintara. "We believe that the financial flexibility provided by this agreement will further support our clinical development efforts with VAL-083 in glioblastoma and REM-001 in cutaneous metastatic breast cancer."

Additional information regarding the purchase agreement is set forth in a Current Report on Form 8-K, which Kintara will file with the Securities and Exchange Commission (SEC).

The securities described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-254662) filed with the SEC on March 24, 2021 and declared effective on April 1, 2021. The offering of the securities described herein will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by request from Kintara Therapeutics at 9920 Pacific Heights Blvd., Suite 150, San Diego, CA 92121 or at (858) 350-4364.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On August 3, 2022 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, reported second quarter 2022 financial results and provided a corporate update (Press release, Kiniksa Pharmaceuticals, AUG 3, 2022, View Source [SID1234617378]).

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"The continued momentum of ARCALYST in recurrent pericarditis in the second quarter of 2022 provides conviction in our full-year expectation for net revenue of between $115 to 130 million. Additionally, we believe the strong performance of ARCALYST since launch supports incremental investment to broaden our reach and help even more patients suffering from recurrent pericarditis," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "We are also focused on expanding our portfolio by leveraging our cross-functional cardiovascular expertise. These efforts will be enabled in part by the non-dilutive proceeds from our global license agreement with Genentech."

Corporate Update:

Today, Kiniksa announced a global license agreement with Roche and Genentech, a member of the Roche Group (Genentech), for the rights to develop and commercialize vixarelimab.
Kiniksa will receive upfront and near-term proceeds of $100 million. In addition, the company is eligible to receive up to approximately $600 million in certain development, regulatory, and sales-based milestones, before fulfilling upstream financial obligations, as well as royalties on annual net sales.
Kiniksa completed screening patients for the Phase 2b clinical trial of vixarelimab in prurigo nodularis and plans to complete the trial. The company will not disclose data in the second half of 2022.
Kiniksa plans to use the non-dilutive proceeds received from the transaction to advance synergistic cardiovascular opportunities.
Portfolio Execution
ARCALYST (IL-1α and IL-1β cytokine trap)

ARCALYST net revenue was $27.0 million for the second quarter of 2022.
More than 550 prescribers have written ARCALYST prescriptions for recurrent pericarditis since launch, with a growing number of repeat prescribers.
More than 90% payer approval rate of completed patient cases for recurrent pericarditis in the second quarter of 2022.
ARCALYST use in recurrent pericarditis to date indicates continuous treatment durations of approximately 12 months.
Kiniksa plans to evolve its sales operation with approximately 20 additional field sales representatives in the fourth quarter of 2022.
KPL-404 (monoclonal antibody inhibitor of CD40-CD154 interaction)

Kiniksa is conducting a Phase 2 clinical trial of KPL-404 in rheumatoid arthritis which is designed to evaluate the efficacy, dose response, pharmacokinetics, and safety of chronic subcutaneous dosing over 12 weeks.
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)

Kiniksa is evaluating the development of mavrilimumab in rare cardiovascular diseases where the granulocyte macrophage colony stimulating factor (GM-CSF) mechanism has been implicated and that have synergies with the company’s existing commercial infrastructure.
Financial Results

Total net revenue for ARCALYST product sales in the second quarter of 2022 was $27.0 million, compared to $7.7 million for the second quarter of 2021.
Total operating expenses for the second quarter of 2022 were $46.3 million, compared to $48.3 million for the second quarter of 2021.
Collaboration expense in the second quarter of 2022 was $3.7 million. Kiniksa did not report a collaboration expense in the second quarter of 2021.
Non-cash, share-based compensation expense for the second quarter of 2022 was $6.7 million, compared to $5.7 million for the second quarter of 2021.
Net loss for the second quarter of 2022 was $20.0 million, compared to a net loss of $41.6 million for the second quarter of 2021.
As of June 30, 2022, the company had $138.2 million of cash, cash equivalents, and short-term investments, and no debt.
Financial Guidance

Kiniksa continues to expect ARCALYST net revenue for the full-year 2022 to be between $115 million and $130 million.
Kiniksa expects that its cash and cash equivalents will fund its current operating plan into at least 2025 following the close of the vixarelimab global license agreement with Genentech.
Conference Call Information

Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Wednesday, August 3, 2022, to discuss second quarter 2022 financial results and to provide a corporate update.
Individuals interested in participating in the call should dial (800) 715-9871 (U.S. and Canada) or (646) 307-1963 (international) using conference ID number 1606846. To access the webcast, please visit the Investors and Media section of Kiniksa’s website. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours after the event.

On August 3, 2022 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), reported topline results that neither the primary endpoint of Overall Response Rate (ORR) nor the key secondary endpoint in Progression Free Survival (PFS) achieved statistical significance in the multi-center, international Phase III AGENT Study of arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab in metastatic colorectal cancer (mCRC) (Press release, Isofol Medical, AUG 3, 2022, View Source [SID1234617377]).

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The information in the press release is intended for investors.

The AGENT Study is the first to evaluate a meaningful alternative to the standard of care for all patients with mCRC since 2004. In the AGENT study, patients with non-resectable mCRC treated with arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab did not achieve a statistically significant overall response rate of ≥ 10% as compared to patients treated with the standard of care (leucovorin + 5-FU, oxaliplatin and bevacizumab).

"We are all surprised and disappointed in the results as we invested so much hope into improving the treatment for patients suffering mCRC. I would like to thank all the patients, clinical investigation sites and other participants that contributed to the study," said Ulf Jungnelius, CEO of Isofol. "We will complete the data analysis before confirming next steps and look forward to working with regulatory agencies to consider alternative paths forward. Decisions related to Isofol’s clinical program will be on hold until we’ve consulted with relevant regulatory bodies which is tentatively planned during the first half of 2023."

The AGENT Study will be completed in accordance with applicable regulations and the full data set will be published in order to enable the scientific community to fully take advantage of learnings. Sub-group analyses, gene expression and safety data is expected to be available in the final study report in Q4 2022. Pending results of further analyses, patients remaining on treatment in the experimental arm of the study will be offered to move to the standard of care treatment arm.

Audiocast, August 4, at 10:00 a.m. CEST
In connection to this announcement Isofol invites investors, analysts, and media to an audiocast with a Q&A-session. The presentation will be held in English by Isofol’s CEO Ulf Jungnelius and CMO Roger Tell and will conclude with a Q&A session. Questions can be asked on the telephone conference or in written form through the audiocast. No preregistration is needed.

This is information that Isofol Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 15:30 CEST on August 3, 2022.

About the AGENT Study
The Phase III AGENT Study is the first to evaluate a meaningful alternative to the standard of care for most patients with metastatic colorectal cancer (mCRC) in 20 years and involves approximately 90 clinics in the U.S., Canada, Europe, Australia, and Japan. The Phase III randomized, controlled, multi-center study of 490 patients assessed the efficacy and safety of arfolitixorin, [6R]-5,10 methylene-THF (MTHF), compared to leucovorin, both used in combination with 5-U, oxaliplatin, and bevacizumab, in first line mCRC patients.

The study was designed to show superiority for arfolitixorin over leucovorin. Patients were randomized in a 1:1 ratio with the primary endpoint being an overall response rate (ORR) >10 percent improvement vs. the control arm. The key secondary endpoint is a clinically meaningful positive trend in progression free survival (PFS). Other secondary endpoints include duration of response (DOR), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumor cells.

On August 3, 2022 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases, reported that it will report second quarter earnings, before the US markets open on Wednesday, August 10, 2022 (Press release, Immunocore, AUG 3, 2022, View Source [SID1234617376]). Following the announcement, the Company will host a live teleconference and webcast at 8:00 a.m. EDT (1:00 p.m. BST) to discuss their financial results and provide a business and portfolio update.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Audio webcast
The call will be made available via webcast by visiting the Events & Presentations section on Immunocore’s website. A replay of this webcast will be available for 90 days.