On August 14, 2023 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the second quarter ended June 30, 2023, and provided recent corporate updates (Press release, Galera Therapeutics, AUG 14, 2023, View Source [SID1234634375]).

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"Following the FDA’s decision on the avasopasem NDA, we have taken decisive steps to extend our cash runway as we seek a Type A meeting with the FDA to discuss the potential path forward for approval," said Mel Sorensen, M.D., Galera’s President and CEO. "In parallel, enrollment continues in the ongoing GRECO trials of rucosopasem, our anti-cancer candidate, as we investigate the novel compound’s potential to enhance stereotactic body (high daily dose) radiotherapy and extend the lives of patients with deadly cancers."

Radiotherapy-Induced Severe Oral Mucositis (SOM)

In August 2023, the Company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for avasopasem for radiotherapy-induced SOM in patients with head and neck cancer (HNC) undergoing standard-of-care treatment. In the CRL, the FDA communicated that the results from the Phase 3 ROMAN trial together with the supporting data from the GT-201 trial are not sufficiently persuasive to establish substantial evidence of avasopasem’s effectiveness and safety for reducing SOM in patients with HNC. FDA stated that results from an additional clinical trial will be required for resubmission. The Company intends to request a Type A meeting with the FDA to understand the FDA’s rationale for its decision and discuss next steps to support an NDA resubmission seeking approval of avasopasem.
Cisplatin-Related Chronic Kidney Disease

In June 2023, Galera presented an abstract featuring avasopasem, as part of the Head and Neck Cancer session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which took place June 2-6, 2023, in Chicago, IL. The abstract, titled "One-year reductions in cisplatin-related chronic kidney disease (CKD) in patients with head and neck cancer (HNC) treated with avasopasem manganese: A prespecified analysis from the Phase 3 ROMAN trial," noted significant improvements in preservation of kidney function compared to placebo based on mean change in estimated Glomerular Filtration Rate, beginning by 3 months through one-year end of follow-up. Reductions in CKD were consistent across cisplatin dosing schedules.
Locally Advanced Pancreatic Cancer (LAPC)

Enrollment is ongoing in the randomized, placebo-controlled Phase 2b GRECO-2 trial of rucosopasem in combination with SBRT in patients with LAPC. The primary endpoint of the trial is overall survival. Completion of enrollment continues to be anticipated in the first half of 2024, and topline data readout is expected by the end of 2024.
In May 2023, the FDA granted Orphan Drug Designation for rucosopasem for the treatment of pancreatic cancer.
Non-Small Cell Lung Cancer (NSCLC)

Enrollment is ongoing in the randomized, placebo-controlled Phase 2 stage of the GRECO-1 trial of rucosopasem in combination with SBRT in patients with NSCLC. Completion of enrollment continues to be anticipated in the second half of 2023, and topline data readout is expected in the second half of 2024.
General Corporate Updates

In connection with the CRL announcement, on August 9, 2023, the Company further announced it will focus resources on defining the path forward for avasopasem, progressing the ongoing clinical trials for rucosopasem, and concurrently evaluating strategic alternatives, including partnering, for the continued development of avasopasem and rucosopasem. As a result, the Company reduced its workforce by approximately 70%. The plan includes a wind-down of commercial readiness efforts and headcount reductions across several departments.
Second Quarter 2023 Financial Highlights

Research and development expenses were $7.6 million in the second quarter of 2023, compared to $6.6 million for the same period in 2022. The increase was primarily attributable to an increase in rucosopasem development costs, partially offset by a decrease in avasopasem development costs.
General and administrative expenses were $9.2 million in the second quarter of 2023, compared to $5.3 million for the same period in 2022. The increase was primarily attributable to avasopasem commercial preparations.
Galera reported a net loss of $(20.7) million, or $(0.48) per share, for the second quarter of 2023, compared to a net loss of $(14.6) million, or $(0.54) per share, for the same period in 2022.
As of June 30, 2023, Galera had cash, cash equivalents and short-term investments of $38.8 million. Galera expects that its existing cash, cash equivalents and short-term investments, taking into account the implementation of the reduction in workforce announced in August 2023, will enable Galera to fund its operating expenses and capital expenditure requirements into the second quarter of 2024.

On August 14, 2023 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 2023 financial results and provided a corporate update (Press release, Instil Bio, AUG 14, 2023, View Source [SID1234634374]).

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"Successful manufacturing of ITIL-306 in our Manchester, UK facility is a major milestone on our path to clinical development of ITIL-306," said Mark Dudley, Chief Scientific Officer of Instil Bio. "We have implemented improvements to the manufacturing process of ITIL-306 that were shown to result in a doubling of the number of CoStAR-TILs in the final product, which we believe could be meaningful for the therapeutic profile of ITIL-306 in patients with advanced cancer."

Second Quarter 2023 Highlights and Anticipated Milestones:

ITIL-306, first CoStAR-TIL in clinical development, anticipated to start clinical trial ITIL-306-202 in 2H 2023: Instil anticipates initiating phase 1 clinical trial ITIL-306-202 with an updated trial design versus ITIL-306-201; the ITIL-306-202 trial design has received positive initial feedback from the Medicines and Healthcare products Regulatory Agency, or MHRA in the United Kingdom. Instil expects Clinical Trial Application, or CTA, clearance from the MHRA in the second half of 2023 and initial clinical data from the ITIL-306-202 clinical trial in 2024.

ITIL-306 operational in Manchester, UK manufacturing facility: Instil has successfully established ITIL-306, including multiple successful verification runs, in its Manchester, UK manufacturing facility. Instil has designed and implemented manufacturing process improvements that resulted in a doubling of the final yield of CoStAR-TILs from verification runs.

Cash runway beyond 2026: Instil Bio confirms its previous guidance of cash runway beyond 2026.
Second Quarter 2023 Financial and Operating Results:

As of June 30, 2023, Instil had cash, cash equivalents, restricted cash and marketable securities of $202.9 million, which consists of $21.8 million in cash and cash equivalents, $1.2 million in restricted cash and $179.9 million in marketable securities, compared to $260.9 million in total cash and cash equivalents and marketable securities, consisting of $43.7 million in cash and cash equivalents and $217.2 million in marketable securities as of December 31, 2022. Instil expects that its cash, cash equivalents and marketable securities as of June 30, 2023 will enable it to fund its operating plan beyond 2026.

Research and development expenses were $8.5 million and $29.1 million for the three and six months ended June 30, 2023, respectively, compared to $41.5 million and $80.7 million for the three and six months ended June 30, 2022, respectively.

General and administrative expenses were $11.5 million and $24.7 million for the three and six months ended June 30, 2023, respectively, compared to $17.2 million and $32.3 million for the three and six months ended June 30, 2022, respectively.

Restructuring and impairment charges were $1.0 million and $25.6 million for the three and six months ended June 30, 2023, respectively.

On August 14, 2023 Intensity Therapeutics, Inc. (Nasdaq: INTS), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported financial results for the second quarter ended June 30, 2023, and provided a corporate update (Press release, Intensity Therapeutics, AUG 14, 2023, View Source [SID1234634373]).

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"The second quarter of 2023 was transformative for Intensity Therapeutics, during which, we closed an upsized initial public offering (IPO), priced at top-of-the-range, despite a turbulent biotech capital market environment. The $20.5 million of net proceeds now allows us to further the development of our lead product candidate, INT230-6, into registration studies," stated Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. "Notably, in June, our trial investigators presented new data at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from the IT-01 phase 1/2 clinical study of INT230-6, either as monotherapy or in combination with ipilimumab in patients with relapsed, refractory and metastatic sarcomas, as well as from the phase 2 INVINCIBLE study of INT230-6 in presurgical breast cancer patients. The data demonstrated that, for all sarcoma patients receiving at least one dose of INT230-6, alone, the median overall survival was 21.3 months, compared to the typical 7 to 10 months in historical phase 1/2 studies. As a result of this compelling data, interest in our novel approach was especially high among the physicians who treat sarcoma, a deadly disease in desperate need of new therapeutic approaches. We intend to submit an Investigational New Drug (IND) application for a phase 3 study of INT-230-6 in soft tissue sarcoma by the end of this year.

"Additionally, Angel Arnaout, M.D., Scientist and Surgical Oncologist at the Ottawa Hospital, and Professor of Surgery at the University of Ottawa was the lead author on the poster reporting INVINCBLE results at ASCO (Free ASCO Whitepaper) on the use of INT230-6 in early stage breast cancer. Results from Part 2 of our INVINCIBLE study showed high levels of tumor necrosis, expression levels of dendritic cells, macrophages and CD4 T-cells tumor influx, post treatment using INT230-6, when comparing patients treated with drug versus those in the control group. Dr. Arnaout commented on how our new drug may shift the way all cancer patients awaiting surgery are treated. Looking ahead, we expect to report additional data from the INVINCIBLE study by year end and are planning to launch a phase 2/3 program in a presurgical breast cancer setting," concluded Mr. Bender.

Recent Company Highlights

● June 2023: Closed an upsized IPO of 3.9 million shares of common stock at a public offering price of $5.00 per share, representing the top-of-the-range, raising net proceeds of $20.5 million after full 15% over-allotment.

● In June: Reported data at ASCO (Free ASCO Whitepaper) from 29 metastatic sarcoma patients enrolled in the IT-01 study of lead product, INT230-6, a locally delivered potent cytotoxic treatment; data showed extended survival in refractory soft tissue sarcoma subjects by nearly 450 days compared to a synthetic control and that treatment with INT230-6 induced an immune response in sarcoma tumors. Safety data was favorable with the majority of adverse events being low grade.

● In June: Presented data at ASCO (Free ASCO Whitepaper) meeting from the INVINCIBLE study of INT230-6 in presurgical breast cancer, which reported that gene enrichment pathway analysis demonstrated INT230-6 induced signaling in the post-treatment samples, immune priming in historically quiescent breast cancers and induced T-Cell receptor signaling, macrophage markers, and IL-18 and B-Cell Receptor signaling. Previously at ASCO (Free ASCO Whitepaper) and other oncology conferences, the Company reported that INT230-6 resulted in major pathological reduction in several early breast cancer patients with up to 100% tumor necrosis after one intratumoral (IT) dose.

● Completed first drafts of the IT-01 clinical study reports for INT230-6 alone, in combination with Merck’s immunotherapy drug pembrolizumab and in combination with Bristol-Myers Squibb’s immunotherapy drug, ipilimumab.

Anticipated 2023 Clinical Milestones

● Report additional results from IT-01 phase 1/2 clinical trial of INT230-6 involving metastatic sarcomas.

● Report additional results from the phase 2 INVINCIBLE study in presurgical breast cancer.

● File an Investigational New Drug (IND) application for a phase 3 study of INT230-6 in soft tissue sarcoma.

● Finalize the study design and a protocol for a phase 2/3 program in presurgical breast cancer.

Second Quarter 2023 Financial Highlights

Research and Development (R&D) Expenses were $0.9 million for the three months ended June 30, 2023 as compared to $1.4 million for the same period last year. The 38.0% decrease reflects the fact that Study IT-01 and Study IT-02 no longer have patient care costs and the drafting of results is nearly complete. Phase 3 IT-03 in sarcoma and phase 2/3 IT-04 in presurgical breast cancer will continue to incur planning, multiple regulatory filing, manufacturing, study initiation and trial preparation costs in 2023.

General and Administrative (G&A) Expenses were $363,000 for the three months ended June 30, 2023 as compared to $545,000 for the same period in 2022. The decrease is primarily due to the prior year having higher costs relating to SEC filings and IPO expenses. The accounting services and legal costs related to the IPO in 2023 were charged directly to the equity section of the balance sheet as a reduction of additional paid in capital.

Interest Expense for the three months ended June 30, 2023 were $222,000 as compared to $15,000 for the three months ended June 30, 2022. The increase is due to the execution of additional convertible notes in 2023.

Net Operating Loss for the second quarter ended June 30, 2023 was $1.2 million as compared to $1.9 million for the three months ended June 30, 2022.The current quarter includes a non-operating loss of $2.3 million which is the discount from the IPO price that was given to convertible debt holders as part of their agreements.

Cash and Cash Equivalents as of June 30, 2023, were approximately $136,000. After accounting for the total net cash proceeds received following the closing of the IPO, of approximately $20.5 million, the Company expects to have sufficient cash to fund current operations until early in the third quarter of 2025.

Conference Call and Webcast Information

The Company will hold a conference call today at 8AM EDT.

To participate in the conference call, please dial 1-877-317-6789 (domestic) or 1-412-317-6789 (international). To access a live webcast of the call, please visit: View Source

An archived replay of the webcast will be available for one year on the Intensity Therapeutics website at: View Source

On August 14, 2023 Bio-Techne (NASDAQ: TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities, reported that the company will end their collaboration with Akoya Biosciences to co-develop an automated RNAscope workflow for use with the PhenoCycler-Fusion System (Press release, Bio-Techne, AUG 14, 2023, View Source [SID1234634372]). The decision was made following best efforts to achieve the intended program goals.

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"Bio-Techne remains focused on providing the greatest value to the spatial biology community," said Kim Kelderman, President of Bio-Techne’s Diagnostics and Genomics Segment. "We are actively expanding the capabilities of our gold-standard RNAscope technology to enable greater utility in multiomic spatial applications and plan to accelerate the development and commercialization of the first fully automated and scalable spatial multiomics workflow on the Lunaphore COMET system."

Bio-Techne will continue to support its customers utilizing RNAscope assays in conjunction with Opal reagents and PhenoImager HT systems purchased from Akoya.

On August 14, 2023 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, reported financial results and recent highlights for the second quarter ended June 30, 2023 (Press release, 2seventy bio, AUG 14, 2023, View Sourcenews-releases/news-release-details/2seventy-bio-reports-second-quarter-financial-results-and-0" target="_blank" title="View Sourcenews-releases/news-release-details/2seventy-bio-reports-second-quarter-financial-results-and-0" rel="nofollow">View Source [SID1234634371]).

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"We launched 2seventy in late 2021 with the stated mission of delivering more time for people living with cancer through the transformative power of cell therapy," said Nick Leschly, chief kairos officer. Since the creation of 2seventy, our mission has always been dual-pronged: to deliver on the commercial potential of Abecma and to leverage our translational engine to develop an innovative cell therapy pipeline. Over the course of this year, we continue to make progress against this goal. We have successfully delivered Abecma to an extensive and growing number of patients in need of new treatment options. While the competitive intensity has increased and will have an impact on revenue in the 2nd half of 2023, we believe in the long-term commercial potential of this important therapy, particularly as we move toward earlier lines. On the development side, in June, we paused our PLAT-08 study in AML due to a Grade 5 safety event and this has since been followed by a clinical hold by FDA. We’ve collaborated with Seattle Children’s to conduct a root-cause analysis and developed amendments to the protocol. Seattle Children’s will review these amendments with FDA with the goal of resuming the study as soon as possible."

SELECT COMMERCIAL AND FINANCIAL HIGHLIGHTS

Second quarter Abecma U.S. revenues, as reported by Bristol Myers Squibb (BMS), were $115 million. Based on BMS reporting an expected decline in Abecma sales in the third quarter, the Company believes Abecma will achieve the lower end of U.S. revenue guidance of $470-570 million.
2seventy bio and BMS share equally in all profits and losses related to development, manufacturing, and commercialization of Abecma in the U.S. 2seventy bio reported collaborative arrangement revenue of $24.5 million and $47.5 million for the three months and six months ended June 30, 2023, respectively.
2seventy bio believes Abecma has potential peak U.S. revenues of $2 to 3 billion.
The Company ended the second quarter of 2023 with cash, cash equivalents and marketable securities of $307 million. 2seventy bio believes that this cash position, combined with growing Abecma cashflow and disciplined expense management, provides financial runway into 2026.
"With the revenue from our Abecma collaboration and careful expense management, we significantly reduced our net loss to $42.1 million in the second quarter from $77.4 million for the same period last year," said Chip Baird, chief financial officer. "We are committed to advancing toward breakeven operations for the business while prudently investing in innovation."

ABECMA CLINICAL, REGULATORY, AND MANUFACTURING UPDATE

2seventy bio, in collaboration with BMS, continues to build on established manufacturing capacity of Abecma with an additional ramp-up planned for later this year.
The collaboration remains on track for introduction of suspension-based lentiviral vector (sLVV) in 1st half 2024.
Manufacturing performance metrics remain strong, with greater than 90% in spec rates and an average turnaround time of ~29 days.
The planned maintenance shutdown of the S12 drug product manufacturing plant was successfully completed in June and the facility is fully operational.
In addition to increasing manufacturing capacity, commercial efforts are underway to expand the U.S. treatment center footprint.
We continue to anticipate the December 16 PDUFA goal date for potential label expansion based on the KarMMa-3 data.
The Company, with BMS, is planning to initiate the KarMMa-9 study in patients with newly diagnosed multiple myeloma later this year.
UPDATE ON PLAT-08 CLINICAL STUDY OF SC-DARIC-33 IN ACUTE MYELOID LEUKEMIA (AML)

In June, the Company announced that because of a fatal (Grade 5) serious adverse event (SAE) in a patient enrolled in the Phase 1 trial of the PLAT-08 study of SC-DARIC33 in AML, the study met protocol-defined pausing rules, pending review of the event by the appropriate regulatory and monitoring boards. On Friday, August 11, 2023, the U.S. Food and Drug Administration (FDA) formally placed the study on clinical hold via email communication. Since the study pause in June, 2seventy bio and Seattle Children’s have been conducting an internal investigation and root cause analysis of the SAE. This investigation provided insights into the potential pathobiology of this toxicity which led to several study protocol changes, which the team believes may mitigate this toxicity and allow for the continuation of the PLAT-08 study. 2seventy bio and Seattle Children’s will continue to work with FDA to provide the root cause analysis and proposed changes for the clinical study. Based on upcoming discussions with FDA, 2seventy bio and Seattle Children’s plan to amend the study accordingly and resume this study as soon as possible.

RECENT DATA HIGHLIGHTS

Abecma Data at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper): The Company presented four abstracts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and six abstracts at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress. The presentations highlighted clinical and correlative data from the KarMMa-2 and KarMMa-3 clinical trials evaluating Abecma in patients with relapsed and/or refractory multiple myeloma (RRMM) or newly diagnosed multiple myeloma, reinforcing Abecma’s strong clinical profile. Additional data on patient-reported outcomes from the KarMMa-3 trial were also presented. Results showed that patients with triple-class exposed RRMM treated with Abecma demonstrated statistically significant and clinically meaningful improvements in health-related quality of life, including key multiple myeloma symptoms and overall functions compared to standard regimens.
New Preclinical and Clinical Data at ASGCT (Free ASGCT Whitepaper): 2seventy bio presented five abstracts, including one late-breaking oral presentation, at this year’s American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting.
UPCOMING ANTICIPATED PIPELINE MILESTONES

Update from Phase I CRC-403 study of bbT369 in patients with relapsed and/or refractory B cell non-Hodgkin lymphoma (B-NHL) anticipated by the end of 2023.
Submission of an Investigational New Drug (IND) application for MUC-16 program in ovarian cancer, being developed in partnership with Regeneron anticipated by end of 2023.
Led by JW Therapeutics, initiation of an investigator-initiated study in China of 2seventy bio’s potency enhanced MAGE-A4 T cell receptor (TCR) program in solid tumors anticipated by end of 2023.
SELECT SECOND QUARTER FINANCIAL RESULTS

Total 2seventy bio revenues were $36.0 million for the three months ended June 30, 2023, compared to $13.5 million for the three months ended June 30, 2022. Total revenues were $77.7 million for the six months ended June 30, 2023, compared to $21.9 million for the six months ended June 30, 2022.
Research and development expenses were $60.0 million for the three months ended June 30, 2023, compared to $64.6 million for the three months ended June 30, 2022. Research and development expenses were $128.2 million for the six months ended June 30, 2023, compared to $130.4 million for the six months ended June 30, 2022.
Selling, general and administrative expenses were $19.5 million for the three months ended June 30, 2023, compared to $17.3 million for the three months ended June 30, 2022. Selling, general and administrative expenses were $40.2 million for the six months ended June 30, 2023, compared to $41.1 million for the six months ended June 30, 2022.
Net loss was $42.1 million for the three months ended June 30, 2023, compared to $77.4 million for the three months ended June 30, 2022. Net loss was $89.1 million for the six months ended June 30, 2023, compared to $163.1 million for the six months ended June 30, 2022.
Conference Call Information

2seventy bio will host a conference call and live webcast today, August 14, at 8:00 a.m. ET to discuss 2Q 2023 financial results and recent business highlights. To join the live conference call, please register at: https://register.vevent.com/register/BIa4096e5acd24407e8d1e2a5e32ba2e14. Upon registering, each participant will be provided with call details and access codes. The live webcast may be accessed by visiting the event link at: View Source A replay of the webcast may be accessed from the "News and Events" page in the Investors and Media section of the Company’s website at View Source and will be available for 30 days following the event.