On August 10, 2023 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported financial results for the fiscal quarter ended June 30, 2023, and provided business updates (Press release, Erasca, AUG 10, 2023, View Source [SID1234634188]).

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"Our team continues to achieve important milestones for our four clinical programs that underscore their potential to address unmet needs for multiple patient segments affected by oncogenic RAS/MAPK pathway signaling," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Expansion of ERAS-007 plus encorafenib and cetuximab (EC) in patients with EC-naïve BRAF-mutated (BRAFm) colorectal cancer (CRC) is advancing following the encouraging early efficacy data seen in HERKULES-3 [50% (3/6) response rate (2 cPR, 1 uPR) at the highest dose tested]. We are also building on the encouraging initial Phase 1b dose escalation data for ERAS-601 plus cetuximab in FLAGSHP-1, with Phase 1b combination dose expansion data planned for the first half of 2024."

Dr. Lim continued, "Importantly, we remain on track to dose the first patient in the SEACRAFT-1 Phase 1b trial in RAS Q61X solid tumors for our most advanced program, the potential first-in-class and best-in-class pan-RAF inhibitor naporafenib. Finally, we are continuing to advance our CNS-penetrant EGFR inhibitor ERAS-801, which was granted FDA Fast Track and Orphan Drug Designations, in recurrent glioblastoma (GBM). Our balance sheet continues to be strong, supporting a cash runway into the second half of 2025 and through the execution of meaningful clinical catalysts over the next 18 months."

Research and Development (R&D) Highlights

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Presented Promising HERKULES-3 Phase 1b Data and Refined Pipeline: In June 2023, Erasca presented preliminary Phase 1b data for ERAS-007 in combination with encorafenib + cetuximab (EC) in patients with BRAFm CRC, showing a 50% (3/6) response rate (2 confirmed partial responses, 1 unconfirmed partial response), reinforcing ERAS-007 as a potential best-in-class ERK inhibitor. In addition, a strategic pipeline prioritization sharpened Erasca’s focus on existing programs with the highest probability of success.
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Granted FDA Orphan Drug and Fast Track Designations for ERAS-801: In June 2023, Erasca announced that the United States Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to ERAS-801 (CNS-penetrant EGFR inhibitor) for the treatment of malignant glioma, which includes GBM. In May 2023, Erasca announced that the FDA granted Fast Track Designation (FTD) to ERAS-801 for the treatment of adult patients with GBM with EGFR gene alterations.
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Presented Promising FLAGSHP-1 Phase 1b Data: In April 2023, Erasca presented promising data for ERAS-601 (SHP2 inhibitor) in combination with cetuximab in patients with advanced solid tumors as part of a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
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Announced Publication of Phase 1b Data for Naporafenib: In April 2023, Erasca announced the publication of results in the Journal of Clinical Oncology from the expansion arm of a Phase 1b open label trial evaluating pan-RAF inhibitor naporafenib plus MEK inhibitor trametinib (MEKINIST) in patients with NRASm melanoma. This potential will be further explored in our SEACRAFT-2 pivotal Phase 3 trial.

Corporate Highlights

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Appointed Lead Independent Director: In July 2023, James Bristol, Ph.D., was appointed to the position of lead independent director. In addition to this role, Dr. Bristol shall continue to serve on the board’s compensation committee and nominating and corporate governance committee.
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Strengthened Business Leadership: In May 2023, Erasca promoted David Chacko, M.D., previously Erasca’s chief financial officer, to the dual position of chief financial officer and chief business officer, and Nik Chetwyn, Ph.D., previously Erasca’s senior vice president of operations, to chief operating officer.

Key Upcoming Milestones

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SEACRAFT-1: Phase 1b trial for naporafenib plus trametinib in patients with RAS Q61X tissue agnostic solid tumors
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Dosing of the first patient expected in the second half of 2023
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Initial Phase 1b combination data expected between the second and fourth quarters of 2024
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SEACRAFT-2: Randomized pivotal Phase 3 trial for naporafenib plus trametinib in patients with NRASm melanoma
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Dosing of the first patient expected in the first half of 2024
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HERKULES-3: Phase 1b trial for ERAS-007 plus EC in EC-naïve patients with BRAFm CRC
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Phase 1b combination expansion data in patients with BRAFm CRC expected between the second half of 2023 and the first half of 2024
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FLAGSHP-1: Phase 1b trial for ERAS-601 in patients with advanced solid tumors
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Phase 1b combination expansion data in relevant patient populations, including patients with human papillomavirus (HPV)-negative advanced head and neck squamous cell carcinoma (HNSCC), expected in the first half of 2024
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THUNDERBBOLT-1: Phase 1 trial for ERAS-801 in patients with recurrent GBM
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Initial Phase 1 monotherapy dose escalation data in patients with recurrent GBM expected in the second half of 2023

Second Quarter 2023 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $365.3 million as of June 30, 2023, compared to $435.6 million as of December 31, 2022. Erasca expects its current cash, cash equivalents, and marketable securities balance to fund operations into the second half of 2025.

Research and Development (R&D) Expenses: R&D expenses were $26.2 million for the quarter ended June 30, 2023, compared to $27.5 million for the quarter ended June 30, 2022. The decrease was

primarily driven by decreases in expenses incurred in connection with clinical trials, preclinical studies, discovery activities and outsourced services and consulting fees, partially offset by increases in facilities-related expenses and depreciation, and personnel costs, including stock-based compensation.

General and Administrative (G&A) Expenses: G&A expenses were $9.8 million for the quarter ended June 30, 2023, compared to $8.4 million for the quarter ended June 30, 2022. The increase was primarily driven by personnel costs, including stock-based compensation expense.

Net Loss: Net loss was $31.8 million, or $(0.21) per basic and diluted share, for the quarter ended June 30, 2023, compared to $35.6 million, or $(0.30) per basic and diluted share, for the quarter ended June 30, 2022.

On August 10, 2023 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, reported that Sean McCarthy, D.Phil., chief executive officer and chairman, will present at the H.C. Wainwright Immune Cell Engager Virtual Conference on Thursday, August 17 at 9:00 a.m. ET (Press release, CytomX Therapeutics, AUG 10, 2023, View Source [SID1234634186]).

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A live webcast of the fireside chat will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conferences.

On August 10, 2023 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported corporate updates and financial results for the second quarter ended June 30, 2023 (Press release, CymaBay Therapeutics, AUG 10, 2023, View Source [SID1234634185]).

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Sujal Shah, President and CEO of CymaBay, stated, "I’m incredibly proud of the progress our teams have made thus far this year as we march towards our key and exciting milestone in the third quarter when we expect to report top-line results from RESPONSE, our global phase 3 registration study of seladelpar in patients with primary biliary cholangitis (PBC). With RESPONSE nearing completion and ASSURE having enrolled over 300 patients to date, we believe the seladelpar development program in PBC is one of the most robust development programs in PBC ever conducted. We continue to believe seladelpar has the potential to be a differentiated second-line treatment option offering patients benefits on markers of disease associated with risk of progression and on symptoms. As announced earlier today, we are now also actively recruiting patients in IDEAL, a study to evaluate seladelpar’s effects on biochemical normalization in PBC patients who only achieve a partial response to first-line treatment. We believe data from IDEAL has the potential to reset expectations for second-line treatment in PBC. In anticipation of a successful data readout in RESPONSE and regulatory acceptance, our organizational build efforts are also underway as we start to put together key components of our commercial and medical affairs infrastructure."

Corporate Updates:

Announced the initiation of a 52-week, placebo-controlled, randomized, Phase 3 study Intended to Determine the Effects of seladelpar on normalization of Alkaline phosphatase Levels in subjects with PBC (IDEAL). This study will target enrolling 75 patients, who have an incomplete response or intolerance to ursodeoxychoic acid (UDCA) as well as ALP greater than upper limit of normal (ULN) but less than 1.67xULN, in a 2:1 randomization to oral, once daily seladelpar 10 mg or placebo.
Featured results of our studies at The International Liver Congress 2023 of the European Association for the Study of Liver (EASL). The presentation reported:
Treatment with seladelpar was found to be correlated with decreases in pruritus and Interleukin-31 (IL-31) levels in patients with PBC. We believe this to be the first intervention in PBC to show this correlation. IL-31 is a cytokine known to play a significant role in pruritus in a variety of other diseases.
Transcriptomics data produced from two distinct fibrosis models, coupled with a platform capable of searching publicly available databases, revealed new aspects of the action of seladelpar to reduce established fibrosis.
An analysis revealing that patients previously treated with UDCA, and having elevated levels of alkaline phosphatase (ALP) that do not currently qualify for second-line treatment, very often had additional factors for risk of disease progression. This highlights the potential for a broader population of patients that may benefit from second-line therapy.
Enrollment completed in a Phase 2a proof-of-pharmacology study to evaluate the potential for MBX-2982, a GPR119 agonist, to prevent hypoglycemia in patients with type 1 diabetes. The study is being fully funded by The Leona M. and Harry B. Helmsley Charitable Trust with CymaBay retaining full rights to MBX-2982. Top-line results expected by year-end 2023.
Financial Updates:

Recognized $31.0 million of collaboration revenue in the second quarter of 2023 related to the $34.2 million upfront fee received from the collaboration and license agreement with Kaken Pharmaceutical Co., Ltd. in January 2023 for the development and commercialization of seladelpar in Japan.
Held $213.8 million in cash, cash equivalents and investments as of June 30, 2023. We believe that cash and investments on hand are sufficient to fund CymaBay’s operating plan through the third quarter of 2024.
Second Quarter and Six Months Ended June 30, 2023 Financial Results

Collaboration revenue recognized for the three and six months ended June 30, 2023 was $31.0 million, on completion of the initial technology transfer associated with the license to develop and commercialize seladelpar in Japan. Of the $34.2M upfront payment received from Kaken, $2.7 million remains deferred and will be recognized upon completion of the Company’s ongoing clinical data delivery and CMC development performance obligations.
Research and development expenses for the three months ended June 30, 2023, and 2022 were $19.5 million and $17.9 million, respectively. Research and development expenses for the six months ended June 30, 2023 were $38.1 million and $36.3 million, respectively. Research and development expenses for the three- and six-month periods ended June 30, 2023 increased compared to the corresponding periods in 2022 as we continue to hire additional research and development personnel and engage external contractors to support our clinical studies and potential regulatory submissions.
General and administrative expenses for the three months ended June 30, 2023 and 2022 were $11.6 million and $5.9 million, respectively. General and administrative expenses for the six months ended June 30, 2023 and 2022 were $19.9 million and $12.0 million, respectively. General and administrative expenses for the three and six months ended June 30, 2023 were higher than the corresponding period in 2022 due to an increase in headcount as we continued to add administrative personnel and expand our infrastructure to support our drug development activities and prepare for potential commercialization of seladelpar in PBC.
Net loss for the three months ended June 30, 2023 and 2022 was $0.8 million and $27.1 million, or ($0.01) and ($0.31) per share, respectively. Net loss for the six months ended June 30, 2023 was $29.6 million and $54.9 million, or ($0.30) and ($0.62), respectively. Net loss for the three- and six-month periods ended June 30, 2023 was lower than the corresponding periods in 2022 due primarily to the recognition of $31.0 million of collaboration revenue during the three months ended June 30, 2023 and higher interest income earned on our investments and other income due to refundable tax credits, offset in part by an increase in operating expenses. Overall, we expect operating expenses to increase in the future as we continue to support our ongoing drug development activities and expand on initiatives to plan and prepare for potential commercialization of seladelpar in PBC.
Conference Call Details

CymaBay will host a conference call today at 4:30 p.m. ET to discuss first quarter financial results and provide a business update. To access the live conference call, please dial 1-877-308-2053 from the U.S. and Canada, or 1-212-231-2921 internationally, Conference ID # 22027740. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On August 10, 2023 Cullinan Oncology, Inc. (Nasdaq: CGEM; "Cullinan") a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, reported on recent and upcoming business highlights and announced its financial results for the second quarter ended June 30, 2023 (Press release, Cullinan Oncology, AUG 10, 2023, View Source [SID1234634184]).

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"We have continued to advance our broad portfolio of modality-agnostic cancer therapies during the first half of this year and are poised to continue our momentum," said Nadim Ahmed, Chief Executive Officer of Cullinan. "With our partners at Taiho Oncology, we recently announced the launch of the REZILIENT-3 study, a randomized Phase 3 trial which will evaluate zipalertinib as a first-line treatment for EGFR exon 20 NSCLC patients. We also shared encouraging initial clinical monotherapy data for CLN-619 at ASCO (Free ASCO Whitepaper) in June. Based on that data, we announced monotherapy expansion cohorts in endometrial and cervical cancers. We look forward to presenting the first data from the pembrolizumab combination arm at a medical congress in the future. Further, we recently brought our fifth development program into the clinic with the dosing of the first patient in our Phase 1 study of CLN-978 in relapsed/refractory B cell non-Hodgkin lymphoma. Following an IND clearance earlier this year, we remain on track to bring our sixth program, CLN-617, into the clinic by year-end. With $512.1 million in cash and investments at the end of Q2, we remain well capitalized to continue executing on our strategic objectives and creating value for all of our key stakeholders."

Portfolio Highlights

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Zipalertinib: In August 2023, Cullinan Oncology, in collaboration with our partners at Taiho Oncology, Inc., announced the initiation of REZILIENT-3, a global Phase 3 study evaluating zipalertinib plus chemotherapy versus chemotherapy alone in patients with EGFR exon 20 insertion mutation non-small-cell lung cancer (EGFRex20 NSCLC) in the first-line setting.
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Enrollment continued in the Phase 2b pivotal study of zipalertinib in patients with EGFRex20 NSCLC who have progressed after prior systemic therapy, as well as in a separate cohort of patients progressing after prior treatment with a currently approved agent for EGFRex20 NSCLC.
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CLN-619: CLN-619 is a monoclonal antibody that stabilizes expression of MICA/B on the tumor cell surface to promote tumor cell lysis by both cytotoxic innate and adaptive immune cells. CLN-619 has broad therapeutic potential and is being investigated as both a monotherapy and in combination with checkpoint inhibitor therapy in an ongoing Phase 1 dose escalation study in patients with advanced solid tumors.
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First clinical data for CLN-619 monotherapy in patients with advanced solid tumors were presented during a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting in June 2023. Data demonstrated monotherapy anti-tumor activity of CLN-619 in heavily pre-treated patients with multiple tumor types and an acceptable safety profile with no dose limiting toxicities up to the highest dose tested. Best responses among 22 evaluable patients receiving doses ≥1 mg/kg included 1 confirmed complete response (parotid cancer), 2 confirmed partial responses (endometrial cancer), and 7 patients with stable disease (cervical, ovarian, breast, and salivary gland cancers).
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Based on these clinical observations, Cullinan has initiated monotherapy expansion cohorts in endometrial and cervical cancers and is evaluating potential additional future expansion cohorts.
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Cullinan intends to present initial data from the combination dose escalation arm of the study at a medical meeting in the future.
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CLN-049: CLN-049 is a FLT3xCD3 T cell-engaging bispecific antibody being investigated in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
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Preliminary safety data from an ongoing first-in-human study were published in abstract form as part of the 2023 EHA (Free EHA Whitepaper) Congress in June 2023.
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Enrollment continues in the ongoing Phase 1 multi-ascending dose study using subcutaneous administration.
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CLN-418: CLN-418 is a B7H4x4-1BB fully human bispecific immune activator designed to achieve conditional activation of 4-1BB by targeting B7H4, a tumor-associated antigen that is highly expressed across multiple cancers with minimal expression on normal tissues.
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Enrollment continued in the ongoing Phase 1 dose escalation study in patients with advanced solid tumors. Initial clinical data are expected in 2024.
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CLN-978: CLN-978 is a CD19xCD3 T cell engager with extended serum half-life and robust potency against target cells expressing low levels of CD19.
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In August 2023, Cullinan dosed the first patient in a Phase 1 study of CLN-978 in patients with R/R B-NHL.
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CLN-617: CLN-617 is a cytokine fusion protein uniquely combining IL-2 and IL-12 with a collagen binding domain designed for retention in the tumor microenvironment (TME) following intratumoral injection.
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Cullinan received FDA clearance of its IND application for CLN-617 in March and anticipates initiating a Phase 1 clinical study in the second half of 2023.
Second Quarter 2023 Financial Results

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Cash Position: Cash, cash equivalents, investments, and interest receivable were $512.1 million as of June 30, 2023. This balance includes proceeds of approximately $38.4 million from sales of common stock under the company’s at-the-market offering program. Cullinan expects its cash resources to provide runway into 2026 based on its current operating plan.
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R&D Expenses: Research and development (R&D) expenses were $27.4 million for the second quarter of 2023, compared to $52.1 million for the first quarter of 2023. R&D expenses for the second and first quarters of 2023 included $3.2 million and $3.1 million of equity-based compensation expenses, respectively. The decrease in R&D expenses was primarily related to a one-time $25 million upfront payment in the first quarter of 2023 to in-license U.S. rights to CLN-418 and higher clinical costs, partially offset by lower chemistry, manufacturing and controls costs.
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G&A Expenses: General and administrative (G&A) expenses were $10.2 million for the second quarter of 2023, compared to $10.7 million for the first quarter of 2023. G&A expenses in the second and first quarters of 2023 included $4.7 million and $4.2 million of equity-based compensation expenses, respectively. The decrease in G&A expenses, excluding equity-based compensation, was primarily driven by lower professional services fees.
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Net Loss: Net loss (before items attributable to noncontrolling interest) for the second quarter of 2023 was $32.2 million, compared with net loss of $58.1 million for the first quarter of 2023. Net losses included the items described above, partially offset by interest income of $5.3 million and $4.5 million in the second quarter and first quarter of 2023, respectively.

On August 10, 2023 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported financial results for the second quarter ended June 30, 2023 and provided other recent corporate updates (Press release, Celcuity, AUG 10, 2023, View Source [SID1234634183]).

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"Patient enrollment in the Phase 3 VIKTORIA-1 trial is progressing in-line with our planned timeline. Nearly 200 sites are now recruiting patients in 20 countries," said Brian Sullivan, CEO and Co-Founder of Celcuity. "We are also very encouraged by the updated median PFS and DOR data we reported for gedatolisib in combination with letrozole and palbociclib in the first-line setting. These results continue to drive our confidence that gedatolisib can play an important role in improving outcomes for women with HR+/HER2- advanced breast cancer, regardless of PIK3CA-status."

Second Quarter 2023 Business Highlights and Other Recent Developments

● The VIKTORIA-1 Phase 3 trial remains on track to provide initial data and analysis of the PIK3CA wild type patient sub-group in the second half of 2024 and data for the PIK3CA mutated patient sub-group in the first half of 2025.
○ The Phase 3 VIKTORIA-1 clinical trial is now recruiting patients at nearly 200 sites in 20 countries.
○ VIKTORIA-1 is evaluating gedatolisib in combination with fulvestrant, an endocrine therapy, with and without palbociclib, a CDK4/6 inhibitor, in adults with HR+/HER2- advanced breast cancer.

● In May 2023, updated results from a Phase 1b trial evaluating gedatolisib, in combination with palbociclib and the aromatase inhibitor, letrozole, were presented at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Annual Congress, with data updated as of March 16, 2023.
○ For treatment-naïve patients from Escalation Arm A and Expansion Arm A (n=41), mPFS was 48.6 months, mDOR was 46.9 months, and ORR was 79%.
○ This data compares favorably to published data for current first-line standard-of-care treatments for patients with HR+/HER2- advanced breast cancer.

● In April 2023, Celcuity presented a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating gedatolisib’s superior therapeutic activity relative to the various PI3K, AKT, and mTOR inhibitors, regardless of the cell lines’ PTEN, PI3K, or AKT mutational status in endometrial, ovarian and cervical cancer cell lines.

● Enrollment is ongoing in the FACT-1 and FACT-2 trials for CELsignia selected patients who have early-stage HR+/HER2- breast cancer with interim results expected in the first half of 2024.

Second Quarter 2023 Financial Results

Unless otherwise stated, all comparisons are for the second quarter ended June 30, 2023, compared to the second quarter ended June 30, 2022.

Total operating expenses were $15.1 million for the second quarter of 2023, compared to $9.6 million for the second quarter of 2022. Net cash used in operating activities for the second quarter of 2023 was $9.7 million, compared to $11.3 million for the second quarter of 2022.

Research and development (R&D) expenses were $13.7 million for the second quarter of 2023, compared to $8.4 million for the second quarter of 2022. Of the approximately $5.4 million increase in research and development expenses, $0.5 million was related to increased employee and consulting expenses. The remaining $4.9 million increase in research and development expenses was primarily the result of activities supporting the VIKTORIA-1 pivotal trial.

General and administrative (G&A) expenses were $1.3 million for the second quarter of 2023, compared to $1.2 million for the second quarter of 2022.

Net loss for the second quarter of 2023 was $14.6 million, or $0.66 loss per share, compared to a net loss of $10.0 million, or $0.67 loss per share, for the second quarter of 2022. Non-GAAP adjusted net loss for the second quarter of 2023 was $12.8 million, or $0.58 loss per share, compared to non-GAAP adjusted net loss for the second quarter of 2022 of $8.3 million, or $0.55 per share. Non-GAAP adjusted net loss excludes stock-based compensation expense and non-cash interest expense. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States (GAAP) to non-GAAP financial measures, please see the financial tables at the end of this press release.

At June 30, 2023, Celcuity reported cash, cash equivalents and short-term investments of $146.2 million.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the second quarter financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-888-886-7786 and international callers should dial 1-416-764-8658. A live webcast presentation can also be accessed using this weblink: View Source;tp_key=c09a941d3d. A replay of the webcast will be available on the Celcuity website following the live event.