On August 12, 2021 Checkmate Pharmaceuticals, Inc. (Nasdaq: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported second quarter 2021 financial results and provided a business update (Press release, Checkmate Pharmaceuticals, AUG 12, 2021, View Source [SID1234586427]).

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"We remain excited about the prospects for vidutolimod in melanoma, based upon compelling clinical data to date, as well as our expansion into new tumor types. We are focused squarely on execution of our clinical trials to deliver upon these opportunities, and we anticipate multiple clinical data readouts in 2022," said Barry Labinger, President and Chief Executive Officer of Checkmate.

Second Quarter Business Update

Advancing patient recruitment activities and enrollment across our ongoing clinical trials evaluating vidutolimod, including:
A Phase 2 trial of vidutolimod in combination with nivolumab in anti-PD-1 refractory advanced melanoma, supported by a clinical collaboration with Bristol Myers Squibb.
A randomized Phase 2/3 trial of vidutolimod in combination with nivolumab vs. nivolumab monotherapy in first-line metastatic or unresectable melanoma, also supported by the clinical collaboration with Bristol Myers Squibb.
A Phase 2 trial of vidutolimod in combination with pembrolizumab in recurrent or metastatic squamous cell head and neck cancer. Interim data readouts anticipated beginning 1H 2022 and maturing throughout 2022.
Ongoing start-up activities for the planned expansion of the development program for vidutolimod into cutaneous squamous cell carcinoma and Merkel cell carcinoma, supported by a clinical collaboration with Regeneron to evaluate the combination of vidutolimod and Libtayo (cemiplimab).
Second Quarter 2021 Financial Results

Research and development expenses (R&D): R&D expenses for the three months ending June 30, 2021 were $14.9 million, compared to $6.5 million for the same period in the prior year. This increase reflected a milestone payment of $4.0 million in the second quarter of 2021 triggered by initiation of patient dosing in our refractory melanoma trial, as well as increases in personnel and operating expense for the planning and execution of additional clinical trials with vidutolimod.
General and administration expenses (G&A): G&A expenses for the three months ending June 30, 2021 were $4.1 million, compared to $1.8 million for the same period in the prior year. This increase was primarily attributable to increases in personnel and operating expense incurred in connection with Checkmate operating as a publicly traded company.
Cash, cash equivalents and investments: Cash, cash equivalents and available-for-sale investments were $95.6 million as of June 30, 2021.

On August 12, 2021 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results and provided a corporate update for the second quarter ended June 30, 2021 (Press release, Tempest Therapeutics, AUG 12, 2021, View Source [SID1234586426]).

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"The second quarter of 2021 was an exciting period as Tempest became a public company and the team drove progress in all three of our novel programs," said Steve Brady, chief executive officer of Tempest. "We look forward to the planned opening of the TPST-1120 randomized study in first line hepatocellular carcinoma in collaboration with Roche and the first combination study of TPST-1495, and remain focused on delivering potentially value-creating milestones over the next year and beyond."

Recent Highlights

Public Company Transition: successfully closed merger and concurrent PIPE financing, allowing Tempest to become a public company listed on the Nasdaq Capital Market, and extending runway into 2023 through multiple potential catalysts.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): continued enrollment in monotherapy dose optimization towards recommended Phase 2 dose ("RP2D").
TPST-1120 (clinical PPARα antagonist): (i) completed monotherapy dose escalation and selected 600mg BID as RP2D; (ii) observed stable disease ("SD") in 50% of the monotherapy-treated patients, including prolonged SD in patients with refractory cholangiocarcinoma; and (iii) observed a deep, confirmed partial response in a patient with checkpoint inhibitor-refractory fourth line renal cell carcinoma in the combination study with nivolumab (->60% by RECIST 1.1, durable through 4 scans and ongoing).
TREX-1 Inhibitor (preclinical, tumor-selective STING pathway activator): (i) progressed lead series to picomolar IC50 potency in biochemical assays; and (ii) demonstrated significant proof of concept in a mouse tumor model with systemic delivery of a lead series molecule.
Board of Directors: Christine Pellizzari, J.D., Geoff Nichol, M.B., Ch.B., M.B.A., and Ronit Simantov, M.D., joined the Board of Directors, bringing deeper financial, legal, and clinical development expertise to Tempest.
Planned Near-Term Milestones

TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) selection of monotherapy RP2D expected in the first half of 2022; (ii) commencement of a combination study with an anti-PD-1 checkpoint inhibitor expected prior to the end of 2021; and (iii) commencement of monotherapy expansion in targeted indications and biomarker-selected patient populations expected in the first half of 2022.
TPST-1120 (clinical PPARα antagonist): (i) identification of RP2D of TPST-1120 in combination with nivolumab expected prior to the end of 2021; and (ii) commencement of first line randomized Phase 1b/2 study in hepatocellular carcinoma patients, under a collaboration with F. Hoffman La Roche, expected within the third quarter.
TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in the first half of 2022.
Financial Results

Second Quarter

Tempest ended the second quarter of 2021 with $68.5 million in cash and cash equivalents and short-term restricted cash, compared to $18.8 million in December 31, 2020. The increase was primarily due to the merger and concurrent PIPE, which closed in June 2021.
Net loss and net loss per share for the second quarter of 2021 were $7.1 million and $7.63, respectively, compared to $5.2 million and $11.42, respectively, for the second quarter of 2020. The increase was primarily due to an increase in compensation expense and professional fees associated with the merger.
Research and development expenses for the second quarter of 2021 were $4.2 million, compared to $4.1 million for the same period in 2020. The $0.1 million increase was primarily attributable to increased compensation expenses.
For the three months ended June 30, 2021, general and administrative expenses were $2.6 million compared to $1.1 million for the same period in 2020. The increase was primarily due to growth in compensation expense and professional fees associated with the merger.
Year-to-Date

Net cash used in operations for the six months ended June 30, 2021 was $6.2 million.
Net loss and net loss per share for the six months ended June 30, 2021 were $12.4 million and $17.30, respectively, compared to $9.5 million and $21.28, respectively, for the same period in 2020.
Research and development expenses for the six months ended June 30, 2021 were $7.8 million compared to $7.1 million for the same period in 2020. The $0.7 million increase was primarily due to increased compensation expenses and consulting services.
For the six months ended June 30, 2021, general and administrative expenses were $4.1 million compared to $2.4 million for the same period in 2020.

On August 12, 2021 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported its second quarter 2021 financial results and provided a corporate update (Press release, Instil Bio, AUG 12, 2021, View Source [SID1234586425]).

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"We confirm our commitment to initiating a Phase 2 trial of ITIL-168 in advanced melanoma in the second half of 2021," said Bronson Crouch, Chief Executive Officer of Instil. "With the installation and ongoing qualification of modular clean room pods at our Tarzana, California facility and our progress toward activating additional manufacturing capabilities in Manchester, U.K., we expect increased clinical manufacturing capacity in late 2021 and early 2022 to support our clinical development plans for ITIL-168 and ITIL-306. Our commitment to innovation in manufacturing continues with the development of a shortened 21-day manufacturing process with robust levels of TIL transduction efficiency for ITIL-306, our first genetically engineered CoStAR-TIL. We expect to pursue further enhancements to both ITIL-168 and ITIL-306 manufacturing processes in the future."

Second Quarter 2021 Highlights and Anticipated Milestones:

Clinical Development:

Presented Clinical Data in Advanced Melanoma at AACR (Free AACR Whitepaper): Instil presented clinical data demonstrating a 67% objective response rate and 19% complete response rate from a compassionate use program of TILs for the treatment of metastatic melanoma as a late-breaking e-Poster at the AACR (Free AACR Whitepaper) virtual meeting in April 2021.

Orphan Drug Designation: On April 27, 2021, ITIL-168 received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of melanoma stages IIB to IV.

Phase 2 Clinical Trial Initiation of ITIL-168: Instil expects to start a Phase 2 clinical trial of ITIL-168 for the treatment of advanced melanoma in the second half of 2021. Topline safety and efficacy data would be expected in 2023, followed by submission of a BLA to the FDA and a Marketing Authorization Application to the European Medicines Agency expected in 2023 and 2024, respectively.

Phase 1 Clinical Trial Initiation of ITIL-306: Instil expects to start a Phase 1 clinical trial of ITIL-306 for the treatment of FOLR1-expressing cancer in the first half of 2022.
Manufacturing and Technical Operations:

Facility Readiness for Clinical Trials: Current manufacturing capacity in the U.K. is sufficient to support capacity needs at the start of the expected upcoming Phase 2 clinical trial of ITIL-168. Further expansion of our U.K. manufacturing capacity is expected later this year. Instil has also installed and begun qualification of its modular clean room pods at its Tarzana, California facility. These pods will support U.S. regional manufacturing and are expected to begin producing clinical batches in the first half of 2022.

ITIL-306 Manufacturing Process: Instil’s focus on continued improvements in manufacturing is highlighted by the development of a 21-day manufacturing process for ITIL-306. This process is capable of achieving high TIL transduction efficiencies that are well in excess of published literature.
Second Quarter 2021 Financial and Operating Results:

As of June 30, 2021, cash and cash equivalents totaled $566.7 million, compared to $241.7 million as of December 31, 2020. The Company expects that its cash and cash equivalents as of June 30, 2021 will enable it to fund its operating plan into 2023.

Research and development expenses were $21.2 million and $35.6 million for the three and six months ended June 30, 2021, compared to $2.2 million and $4.2 million for the three and six months ended June 30, 2020.

General and administrative expenses were $14.2 million and $23.2 million for the three and six months ended June 30, 2021, compared to $2.4 million and $4.3 million for the three and six months ended June 30, 2020.

On August 12, 2021 Calliditas Therapeutics AB (publ) ("Calliditas" or the "Company") (Nasdaq Stockholm – CALTX; Nasdaq – CALT), a biopharma company focused on identifying, developing and commercializing novel treatments in orphan indications, reported its intention to carry out a directed issue of common shares of approximately SEK 300 million to Swedish and international institutional investors and sector specialist investors (the "Issue") (Press release, Calliditas Therapeutics, AUG 12, 2021, View Source [SID1234586424]).

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The Issue in brief

The Issue is intended to be carried out with deviation from the shareholders’ preferential rights in accordance with the authorization granted by the Annual General Meeting on May 27, 2021. The subscription price and the total number of new shares in the Issue will be determined through an accelerated book building procedure, which will commence immediately following this press release. The completion, pricing and allocation of the new shares is expected to take place before the beginning of trading on Nasdaq Stockholm at 09.00 CEST on August 13, 2021. By establishing the subscription price in the Issue through an accelerated book building procedure, it is the assessment of the Board of Directors that the subscription price will accurately reflect current market conditions and demand. The closing, pricing and allocation in the book building procedure is at the discretion of the Company and may be cancelled at any time. The Company will announce the outcome of the Issue in a subsequent press release after the book building procedure has been completed.

The Company intends to use the net proceeds from the Issue for:

ongoing clinical development;
pre-commercial development in the United States;
commercial activities for Nefecon, if approved for marketing by the FDA later this year; and
general corporate purposes.
The Company believes that using the flexibility provided by a non-pre-emptive placing is the most appropriate and optimal transaction structure at this time in order to raise capital for the development of ongoing projects in a time and cost-effective manner. Moreover, the Company will further strengthen the shareholder base with Swedish and international institutional investors and sector specialist investors.

In connection with the Issue, the Company has agreed to a lock-up undertaking, with customary exceptions, on future share issuances for a period of 90 days. In addition, members of the Board of Directors and management of Calliditas, who owns shares or warrants, have, in connection with the Issue, agreed not to sell any shares in the Company during a lock-up period of 90 days subject to customary exceptions.

Advisers

In conjunction with the Issue, the Company has engaged Jefferies GmbH, Carnegie Investment Bank AB (publ) and Kempen & Co as Joint Global Coordinators and Joint Bookrunners. Vinge act as legal adviser to the Company and Baker McKenzie act as legal adviser to the Banks.

The information in the press release is inside information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons above, on August 12, 2021 at 17:57 (CEST).

On August 12, 2021 Ikena Oncology, Inc. (Nasdaq: IKNA, "Ikena"), a targeted oncology company focused on developing novel cancer therapies targeting key signaling pathways, reported financial results for the quarter that ended June 30, 2021 (Press release, Ikena Oncology, AUG 12, 2021, View Source [SID1234586423]). The Company also shared updates on several pipeline programs targeting tumor signaling pathways, including Hippo, RAS, and the tumor microenvironment.

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"In recent months, the Ikena team has continued to generate data on the important targets we are exploring and our development candidates. This work has further elucidated the potential of TEAD inhibition as a monotherapy and in combination with other targeted therapies, and enables us to further refine the clinical development strategy for IK-930, our novel TEAD inhibitor," said Mark Manfredi, PhD, Chief Executive Officer of Ikena Oncology. "We look forward to sharing these and more updates as our data matures and we make strides towards our goal to transform the landscape of cancer treatment to a targeted, patient-focused treatment paradigm."

Ikena is also evaluating our novel AHR antagonist, IK-175, in a Phase I clinical trial as a monotherapy and in combination with nivolumab for the treatment of advanced or metastatic solid tumors, including in urothelial carcinoma, a type of bladder cancer where there is a significant unmet need. After completing the monotherapy dose escalation we are progressing the expansion cohort and enrolling additional urothelial carcinoma patients to continue evaluating IK-175 as a monotherapy and the path towards proof-of-concept in this patient population.

"The emerging clinical data observed for IK-175 monotherapy in urothelial carcinoma and the expansion of the cohort are great steps toward establishing proof of concept. These patients have very limited options for treatment, and we are hopeful that IK-175 could have significant impact in this setting," said Sergio Santillana, MD, Chief Medical Officer at Ikena. "The monotherapy cohort expansion is an encouraging development for the Ikena team and ultimately for the patients whose cancer could be treated with this novel therapy. We look forward to generating additional data and providing an update on safety and preliminary anti-tumor activity of IK-175 at a medical conference in 2022."

Recent Pipeline Progress and Corporate Update

IK-930: TEAD Inhibitor in the Hippo Signaling Pathway in IND-enabling Studies
IND-enabling studies continued to progress and the IND submission is on track for the end of 2021.
Translational and preclinical data will be shared at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) 2021 Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) taking place October 7-10, 2021.
Virtual Poster Presentation of IK-930 indication selection methodology and data, highlighting a novel method to assess activation across the Hippo pathway and the rationale behind mesothelioma as a cancer type that could benefit from TEAD inhibition as a monotherapy
Virtual Poster Presentation of the tumor growth inhibition observed in in vivo preclinical models of lung and colon cancer with IK-930 combined with inhibition of MEK and EGFR, separately and in triplet
IK-175: Clinical Stage AHR Antagonist Partnered with Bristol Myers Squibb (BMS)
Ikena is expanding the monotherapy bladder cancer cohort to treat additional patients in the current dose expansion cohort per protocol of the ongoing Phase 1 clinical trial.
Translational and preclinical data will be shared at scientific conferences in the second half of 2021.
Clinical data presentation planned for a major medical conference in 2022.
IK-412: Novel Enzymatic Therapeutic Degrading Kynurenine Partnered with BMS
Ikena was notified in the second quarter that a key component required in the manufacturing of IK-412 is also required for the manufacturing of COVID-19 vaccines and therapies. As a result, the availability of the component for purposes other than vaccine production is extremely limited in the near-term.
This situation impacted our manufacturing lead times, delaying the planned IND submission for IK-412.
Updated guidance on IND submission timing will be provided when material supply of this key component can be reliably projected.
We continue to work closely with our supplier and contract manufacturing organization, as well as our partner BMS, to advance the program toward IND submission.
IND-enabling studies of IK-412 continue to progress as planned.
Additional Pipeline Programs Continue to Progress
Financial Results for the Quarter Ended June 30, 2021

As of June 30, 2021, the Company had cash and cash equivalents totaling $264.0 million, which will fund operations through 2023. Net cash used in operations was $15.7 million for the second quarter of 2021 as compared to $7.7 million for the second quarter of 2020.

Research and development expenses for the second quarter 2021 were $11.4 million, compared to $6.3 million for the second quarter 2020. The increase in R&D expense was primarily related to on-going IND-enabling studies and manufacturing development costs for IK-930, ongoing IND-enabling studies for IK-412, increased research activities of other discovery stage programs and increased personnel expenses due to increase in headcount. The increase in research and development expenses was offset by a decrease in expense attributable to drug manufacturing of IK-175 and a decrease in clinical activities for IK-007.

General and administrative expenses for the second quarter were $4.9 million, compared to $1.8 million for the second quarter 2020. The increase in G&A expense was primarily related to compensation expense due to an increase in headcount, as well as general increases in audit, legal and consulting expenses to support our operations as a public company.

Net loss for the second quarter 2021 was $12.7 million, compared to $5.0 million for the second quarter 2020, driven by increases in research and development and general and administrative expenses.