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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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.

On August 3, 2022 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported that Hugh Young Rienhoff, Jr., MD, CEO of Imago BioSciences, will participate in an analyst led Fireside Chat at the 2022 Wedbush PacGrow Healthcare Conference on August 10, 2022, at 1:10 pm Eastern Time / 10:10 am Pacific Time (Press release, Imago BioSciences, AUG 3, 2022, View Source [SID1234617375]).

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Interested parties can access the live webcast of the Fireside Chat by visiting the Investor Relations section of the company’s website at ir.imagobio.com. A webcast replay will be available after the conclusion of the event for approximately 90 days.