On August 14, 2023 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for second quarter ended June 30, 2023 (Press release, Leap Therapeutics, AUG 14, 2023, View Source [SID1234634377]).

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Leap Highlights:

· Announced that initial data from Part A of the Phase 2 DeFianCe study of DKN-01 in combination with standard of care bevacizumab and chemotherapy as a second-line treatment for patients with advanced colorectal cancer (CRC) exceeded a twenty percent (20%) overall response rate (ORR) with a high disease control rate, leading to the initiation of the 130-patient randomized controlled Part B of the study

· Presented new long-term follow-up data from Part A of the Phase 2 DisTinGuish study of DKN-01 plus tislelizumab and chemotherapy demonstrating 19.5 months median overall survival (OS) in first-line patients with advanced gastroesophageal adenocarcinoma (GEA) at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

"The Company made important progress on our DKN-01 program during the second quarter. Based on Part A of the DeFianCe study exceeding our threshold of a 20% ORR, all of which are now confirmed responses, we initiated Part B, our second randomized controlled trial," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We also presented new long-term follow-up data from Part A of the DisTinGuish study at ASCO (Free ASCO Whitepaper), demonstrating 19.5 months median overall survival which exceeds current benchmarks. Additionally, enrollment continues to be strong in the 160 patient randomized controlled Part C of the DisTinGuish study, and we expect to complete enrollment in the fourth quarter of this year."

DKN-01 Development Update

· Announced initial results from Part A of the DeFianCe Study of DKN-01 for the treatment of colorectal cancer patients and initiation of the randomized controlled Part B of the study. The DeFianCe study (NCT05480306) is a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy for advanced disease. The study began with an initial Part A cohort that enrolled 33 patients, including significant numbers of patients who had early progression on first-line therapy, previous exposure to bevacizumab, tumors with Ras mutations, or liver metastases. Initial results indicated an ORR above twenty percent (20%) with a high disease control rate, which exceeds the benchmarks expected for this population. The study has expanded into a 130-patient Part B randomized controlled trial. The primary endpoint of the randomized study is progression free survival. Secondary objectives include overall response rate, duration of response, and overall survival. Leap expects to be able to enroll Part B in approximately 12 months.

· Presented updated data from Part A of the DisTinGuish Study of DKN-01 plus tislelizumab and chemotherapy in gastric cancer patients at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting. The Company presented new long-term follow-up data in first-line patients with advanced GEA from Part A of the DisTinGuish study (NCT0436380), a Phase 2 clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab and chemotherapy. Highlights from the data include:

o At two years follow up, DKN-01 plus tislelizumab and chemotherapy demonstrated an ORR of 73% in the modified intent-to-treat (mITT) population and 86% in the PD-L1 low-subgroup

o Median OS of 19.5 months and median progression-free survival (PFS) of 11.3 months exceeds benchmark results in the overall population

o Combination was well tolerated with manageable toxicity, with most adverse events related to DKN-01 being low-grade

Selected Second Quarter 2023 Financial Results

Net Loss was $13.4 million for the second quarter 2023, compared to $17.0 million for the same period in 2022. The decrease was primarily due to decreased research and development expenses and increased interest income.

Research and development expenses were $11.1 million for the second quarter 2023, compared to $14.0 million for the same period in 2022. The decrease in research and development expenses was primarily due to a decrease of $4.5 million in manufacturing costs related to clinical trial material, partially offset by an increase of $0.8 million in clinical trial costs and an increase of $0.8 million in payroll and other related expenses due to an increase in headcount of our research and development full-time employees.

General and administrative expenses were $3.6 million for the second quarter 2023, compared to $2.9 million for the same period in 2022. The increase in general and administrative expenses was primarily due to an increase of $0.6 million in professional fees due to higher finance and legal costs associated with our business development activities and a $0.3 million increase in payroll and other related expenses due to an increase in headcount of our general and administrative full-time employees, partially offset by a decrease of $0.2 million in insurance costs.

Interest income was $1.2 million for the second quarter 2023, compared to an immaterial amount for the same period in 2022. The increase reflects the increased interest rate environment applicable to the Company’s cash balance.

Cash and cash equivalents totaled $91.4 million at June 30, 2023. Research and development incentive receivables totaled $2.6 million at June 30, 2023.

On August 14, 2023 Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company focused on discovering and developing medicines that are transformational for patients, reported financial results and business highlights for the second quarter ended June 30, 2023 (Press release, Centessa Pharmaceuticals, AUG 14, 2023, View Source [SID1234634376]).

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"This is an exciting time for Centessa as we continue to execute across our portfolio with the goal of bringing transformative medicines to patients with unmet needs," said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. "We recently commenced dosing in our registrational PRESent-2 study of SerpinPC for the treatment of hemophilia B without inhibitors and are now enrolling subjects across multiple global sites. To date, clinical data support SerpinPC’s potential to be a first-in-class subcutaneously administered therapy with a differentiated safety profile for persons with hemophilia B. In the months ahead, we plan to share new data from subjects with approximately 3 years of continuous treatment with SerpinPC from the ongoing Phase 2a study."

"We are also making great progress with our LockBody technology platform, enrolling and dosing subjects in the ongoing Phase 1/2a clinical trial of LB101, a PD-L1xCD47 LockBody molecule for the treatment of solid tumors. In addition, we are excited to announce LB206, a conditionally bivalent PD-L1xCD3 bispecific monoclonal antibody, as our second LockBody development candidate for the treatment of solid tumors, and share encouraging preclinical data for LB206 which demonstrated the potential of our LockBody technology to selectively drive potent CD3 activity within solid tumors in a difficult-to-treat mouse xenograft model with no apparent observed toxicity. We believe this progress marks an important milestone in advancing our novel LockBody technology platform," said Dr. Saha.

"In parallel with progress on our two clinical programs, we are advancing ORX750, our first oral selective orexin receptor 2 (OX2R) agonist development candidate, through IND enabling studies for the treatment of narcolepsy, and are thrilled to present preclinical data for ORX750 at the World Sleep Congress in October 2023," said Dr. Saha. "We are also excited to be exploring follow-up orexin agonists for potential expansion opportunities into a range of high value sleep disorders and broader neurological indications. With a team comprised of experienced and insightful scientists in the orexin field, we believe Centessa is well-positioned to play a leading role in orexin agonist development."

Dr. Saha concluded, "We have line of sight to multiple potential clinical milestones expected over the next several quarters and with a cash runway into 2026, we believe we are well positioned to advance our pipeline of potentially transformative medicines and deliver value for our stakeholders."

Recent Highlights
•Today, the Company shared new preclinical data for LB206, a PD-L1xCD3 LockBody development candidate, which demonstrated single agent regressions of large tumors in a difficult-to-treat mouse xenograft model. The preclinical data is shown in the Company’s corporate overview for August 2023 which is available at View Source
•In July, the Company announced the dosing of the first subject in its registrational PRESent-2 clinical study of SerpinPC for the treatment of hemophilia B without inhibitors. SerpinPC is an investigational subcutaneously administered novel inhibitor of activated protein C (APC).
•In May, the Company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SerpinPC for the treatment of hemophilia B, with or without inhibitors.

Anticipated Upcoming Program Milestones
•Hemophilia (SerpinPC) – The global registrational program for hemophilia B is ongoing. PRESent-5, an observational feeder study, continues enrolling subjects and the Company has commenced dosing in the registrational PRESent-2 clinical study of hemophilia B without inhibitors. Dosing in the registrational PRESent-3 clinical study of hemophilia B with inhibitors, is expected to begin this year. In addition, the Company expects to share data from Part 5 of the ongoing Phase 2a study of SerpinPC at a scientific meeting later this year.
•Solid Tumors
▪PD-L1xCD47 LockBody (LB101) – The Phase 1/2a first-in-human clinical study is ongoing.
▪PD-L1xCD3 LockBody (LB206) – LB206 has been named as a development candidate.

•Narcolepsy and Other Sleep Disorders (ORX750) – ORX750 is undergoing IND-enabling activities. The Company plans to share preclinical data on ORX750 at the World Sleep Congress taking place from October 20-25, 2023, in Rio de Janeiro, Brazil.

The Company has multiple earlier-stage preclinical assets including additional orexin agonists and discovery-stage programs. Where applicable, the Company plans to provide updates on preclinical programs as they advance toward clinical studies.

Second Quarter 2023 Financial Results
•Cash, Cash Equivalents and Short-term Investments: $303.6 million as of June 30, 2023. In addition, the Company received approximately $15.0 million in gross proceeds through ATM sales in August 2023. The Company expects its current cash, cash equivalents and short-term investments will fund operations into 2026, without drawing on the remaining available tranches under the Oberland credit facility.
•Research & Development Expenses: $33.7 million for the second quarter ended June 30, 2023, compared to $53.7 million for the second quarter ended June 30, 2022.
•General & Administrative Expenses: $13.3 million for the second quarter ended June 30, 2023, compared to $14.8 million the second quarter ended June 30, 2022.
•Net Loss Attributable to Ordinary Shareholders: $24.9 million for the second quarter ended June 30, 2023, compared to $64.7 million for the second quarter ended June 30, 2022. The net loss for the second quarter of 2023 included a tax benefit of $24.1 million, which primarily relates to a release of a valuation allowance on certain U.S. deferred tax assets in the quarter.

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