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Elevation Oncology Reports Second Quarter 2021 Financial Results

On August 12, 2021 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported financial results for the quarter ended June 30, 2021 (Press release, Elevation Oncology, AUG 12, 2021, View Source [SID1234586428]).

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"The second quarter marked a pivotal period for Elevation Oncology, with our debut in the public markets raising over $100 million which extends our cash runway into Q2 2023 and positions the Company to execute on our lead program, seribantumab, and build an industry leading precision oncology pipeline," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "Looking ahead, we anticipate completing enrollment of the first 20 patients in Cohort 1 of the tumor-agnostic Phase 2 CRESTONE study of seribantumab for patients with tumors harboring an NRG1 fusion later this year or in early 2022, and presenting the clinical data from the interim analysis in mid-2022 at a major medical conference. Through our recent coloration with Caris Life Sciences, we are identifying oncogenic fusions and driver mutations to enable pipeline expansion opportunities within genomically defined patient populations as part of our commitment to expand the potential of precision medicine."

Recent Business Highlights

Entered into a collaboration with Caris Life Sciences. In June 2021, Elevation Oncology and Caris announced a strategic collaboration to jointly discover and develop therapeutics targeted against oncogenic fusions and driver alterations. The two Companies will leverage genomic data from Caris’s leading WTS and WES molecular diagnostics platform, prioritize targets that are likely to be actionable driver alterations, and jointly discover and develop therapeutics to target them.

Completed a successful initial public offering (IPO). The Company’s common stock commenced trading on The NASDAQ Global Market under the ticker symbol "ELEV" on June 25, 2021. The IPO raised $106.5 million in gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses.

Strengthened corporate leadership. During the second quarter, the Company appointed Joseph Ferra as Chief Financial Officer, bringing to Elevation two decades of biopharma industry leadership including in investment banking and, most recently, as a public-company CFO. Further, Elevation Oncology appointed Michael Carruthers, an experienced biotech executive, to the Board of Directors and Chair of the Audit Committee.
Clinical Development and Pre-Clinical Data

Opened additional clinical trial sites in CRESTONE. There are now 26 trial sites that are open and enrolling across the US. Through the "just-in-time" clinical site model in partnership with Caris Life Sciences, Tempus, and US Oncology, there are over 400 available sites that can be activated within CRESTONE.

Established additional diagnostic partnerships. With the addition of Genomic Testing Collaborative, PathGroup, and Exactis, there are now a total of nine partnerships in place to support the identification and enrollment of patients with tumors harboring an NRG1 fusion in CRESTONE, including pre-existing partnerships with Ashion Analytics (now Exact Sciences), NeoGenomics, Caris Life Sciences, Strata Oncology, Tempus, and US Oncology.

Presented new preclinical data on additional tumor models harboring an NRG1 fusion. Along with its collaborators in the Marc Ladanyi laboratory at Memorial Sloan Kettering (MSK), the Company presented data at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting 2021. The preclinical data was in pancreatic and cholangiocarcinoma PDX models on the specific inhibition of HER3 with seribantumab to block NRG1 fusion signaling. These results further support the investigation of seribantumab for the treatment of any solid tumor harboring an NRG1 fusion regardless of fusion partner in the ongoing Phase 2 CRESTONE study.

Published a preclinical manuscript on the effect of seribantumab in NRG1 fusion models. A publication in Clinical Cancer Research highlights the specific inhibition of HER3 by seribantumab in preclinical NRG1 fusion in vitro and in vivo PDX models of lung and ovarian cancer. These results showed that seribantumab efficiently inhibited ligand-dependent activation of HER3 by NRG1 fusions, destabilizes the entire ERBB family signaling pathway including the activation of EGFR, HER2, and HER4, and established a predicted biologically effective dose range of seribantumab for tumors driven by an NRG1 fusion that provides confidence in the optimized clinical dose and schedule of 3g weekly being studied in the CRESTONE study.

Published a clinical manuscript. The Phase 1 dose escalation and expansion study for seribantumab monotherapy in patients with advanced solid tumors was published in Investigational New Drugs. The study was designed to evaluate the safety and tolerability of seribantumab monotherapy in patients with any solid tumor, not tumors harboring an NRG1 fusion. Seribantumab monotherapy was well tolerated across all dose levels and a maximum tolerated dose was not reached. Safety and PK data from this study support the 3g weekly dosing of seribantumab in the CRESTONE study which is the first study of seribnatumab in patients with tumors harboring an NRG1 fusion.
Upcoming Milestones

Complete enrollment of the first 20 patients in Cohort 1 of the Phase 2 CRESTONE study and conduct an interim analysis (Q4 2021 – Q1 2022)

Meet with the U.S. Food & Drug Administration to discuss the Phase 2 CRESTONE study (H1 2022)

Present clinical data from CRESTONE interim analysis at a major medical meeting (mid-2022)
Second Quarter 2021 Financial Results

As of June 30, 2021, the Company had cash and cash equivalents totaling $158.0 million, which is expected to fund current operations into the second quarter of 2023.

Research and development expenses for the second quarter 2021 were $3.9 million, compared to $3.0 million for the second quarter 2020. The increase in R&D expense was primarily related to an increase in clinical trial expenses associated with the CRESTONE study.

General and administrative expenses for the second quarter 2021 were $1.1 million, compared to $0.4 million for the second quarter 2020. The increase in G&A expense was primarily related to personnel costs, professional services and consulting, and other administrative costs.

Net loss for the second quarter 2021 was $5.1 million, compared to $3.4 million for the second quarter 2020.

About Seribantumab and NRG1 Gene Fusions

Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner protein to create chimeric NRG1 "fusion proteins". The NRG1 fusion protein is often also able to activate the HER3 pathway, leading to unregulated cell growth and proliferation. Importantly, NRG1 gene fusions are predominantly mutually exclusive with other known genomic driver mutations and are considered a unique oncogenic driver event associated with tumor cell survival.

NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, neuroendocrine, cholangiocarcinomas, and sarcomas. In preclinical experiments, seribantumab prevented the activation of HER3 signaling in cells that harbor an NRG1 gene fusion and destabilized the entire ERBB family signaling pathway including the activation of HER2, EGFR, and HER4. In addition to extensive nonclinical characterization and testing, seribantumab has been administered to over 800 patients across twelve Phase 1 and 2 studies, both as a monotherapy and in combination with various anti-cancer therapies. Seribantumab is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.

About the CRESTONE Study

Clinical Study of Response to Seribantumab in Tumors with Neuregulin-1 (NRG1) Fusions. CRESTONE is a Phase 2 tumor-agnostic "basket trial" of seribantumab in patients with solid tumors that harbor an NRG1 fusion and have progressed after at least one prior line of standard therapy. The primary objective of the study is to describe the anti-tumor activity and safety of seribantumab as a monotherapy specifically in patients whose solid tumor is uniquely driven by an NRG1 gene fusion. CRESTONE offers a clinical trial opportunity for patients with advanced solid tumors who have not responded or are no longer responding to treatment. Patients are encouraged to talk to their doctor about genomic testing of their tumor. CRESTONE is open and enrolling today in the United States. For more information visit www.NRG1fusion.com.

Checkmate Pharmaceuticals Announces Second Quarter 2021 Financial Results and Provides Business Update

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]).

"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.

Tempest Reports Second Quarter 2021 Financial Results and Provides Corporate Highlights

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]).

"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.

Instil Bio Reports Second Quarter 2021 Financial Results and Provides Corporate Update

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]).

"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.

Calliditas Therapeutics intends to carry out a directed share issue

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]).

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).