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.

On August 10, 2023 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing viral immunotherapies to help patients fight cancer, reported its financial results for the second quarter ended June 30, 2023, and provided a corporate update (Press release, Candel Therapeutics, AUG 10, 2023, View Source [SID1234634182]).

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"We continue to be encouraged by the therapeutic potential of our pipeline of oncology drug candidates that have shown clinical activity across multiple hard-to-treat solid tumor cancers," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "With multiple clinical trials underway, we are well-positioned for a number of upcoming data catalysts. We expect to announce additional clinical and immunological biomarker data from our phase 2 clinical trial in late stage PD-(L)1 inhibitor therapy-resistant non-small cell lung cancer in the third quarter of this year and topline overall survival data in the second quarter of 2024. In addition, we plan to announce initial overall survival and immunological biomarker data from the phase 2 clinical trial of CAN-2409 in patients with borderline resectable pancreatic adenocarcimoma in the fourth quarter of 2023."

Dr. Tak further commented, "For our CAN-3110 drug candidate, recent data presented from our phase 1 clinical trial in 50 patients with recurrent high-grade glioma demonstrated that a single injection of CAN-3110 was associated with encouraging median overall survival without dose-limiting toxicities. We have also begun evaluating whether multiple injections of CAN-3110 in this patient population could further boost the anti-tumor immune response with added drug exposure. This clinical trial program may also enable future expansion into other indications that are characterized by Nestin expression. We remain determined in our efforts to bring the next generation of viral immunotherapies to patients with cancer."

Second Quarter 2023 & Recent Highlights

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Program Updates:

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CAN-2409 – Non-Small Cell Lung Cancer (NSCLC)

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Fast Track Designation granted by the U.S. Food and Drug Administration for CAN-2409 plus valacyclovir in combination with continued pembrolizumab in order to improve survival or delay progression in patients with stage III/IV NSCLC who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy.

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Presented an overview of the phase 2 NSCLC clinical trial design, study protocol, and dosing regimen in a trials-in-progress poster session at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Based on the estimated completion of patient enrollment in Cohort 2, expect to report topline overall survival data from the phase 2 NSCLC clinical trial in Q2 2024.

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CAN-3110 – Recurrent High-Grade Glioma (HGG)

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Presented new data at the 2023 American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting. The data from the phase 1 investigator-sponsored clinical trial demonstrated that a single injection of CAN-3110 resulted in a median overall survival (mOS) of 11.8 months in patients with recurrent HGG who had failed standard of care (SoC) treatment. Further results demonstrated CAN-3110 to be well tolerated with no dose-limiting toxicities.

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Advanced patient enrollment in Arm C, supported by the Break Through Cancer Foundation, to evaluate the repeat dosing regimen of CAN-3110 (up to six injections over four months) and whether additional doses can increase mOS.
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Corporate Updates:
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Appointed experienced manufacturing leader Nicoletta Loggia, PhD, RPh, to the Candel Board of Directors.

Anticipated 2023 Milestones

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Expect to announce additional clinical and immunological biomarker activity data from newly enrolled patients and additional follow-up on the 26 patients who received two injections of CAN-2409 in Cohort 2 of the phase 2 clinical trial of CAN-2409 plus valacyclovir combined with continued PD-(L)1 targeting agents in patients with late-stage NSCLC in Q3.

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Expect to announce initial overall survival and immunological biomarker data from the open-label, randomized phase 2 clinical trial of CAN-2409 plus valacyclovir combined with SoC for patients with borderline resectable pancreatic adenocarcimoma in Q4.

Financial Results for the Quarter Ended June 30, 2023

Research and Development Service Revenue, related party: Research and development service revenue, related party, was $0 for the second quarter of 2023 compared to $31,000 for the second quarter of 2022, as the amortizable $1.0 million up-front license fee that Candel received in 2014 and 2015 from Ventagen LLC was fully recognized as of December 2022.

Research and Development Expenses: Research and development expenses were $5.9 million for the second quarter of 2023 compared to $5.0 million for the second quarter of 2022. The increase was primarily due to personnel-related costs for additional headcount and manufacturing activities in support of the Company’s CAN-2409 programs. Research and development expenses included non-cash stock compensation expense of $0.3 million for the second quarter of 2023 compared to $57,000 for the second quarter of 2022.

General and Administrative Expenses: General and administrative expenses were $3.6 million for the second quarter of 2023 compared to $3.8 million for the second quarter of 2022. The decrease was primarily due to lower recruiting and insurance costs, partially offset by an increase in professional service and consulting expenses as well as personnel-related costs for additional headcount. General and administrative expenses included non-cash stock compensation expense of $0.4 million for both the second quarter of 2023 and the second quarter of 2022.

Net Loss: Net loss for the second quarter of 2023 was $9.6 million compared to a net loss of $4.1 million for the second quarter of 2022, and included net other expense of $35,000 and net other income of $4.6 million, respectively, primarily related to the change in the fair value of the Company’s warrant liability.

Cash Position: Cash and cash equivalents as of June 30, 2023 were $51.9 million. The Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into the second quarter of 2024.

On August 10, 2023 Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, reported second-quarter 2023 financial results and provided a corporate update (Press release, Ayala Pharmaceuticals, AUG 10, 2023, View Source [SID1234634181]).

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"We continue to make progress advancing our lead candidate AL102, which is being evaluated in the ongoing Phase 3 registration-enabling RINGSIDE for the treatment of desmoid tumors. We recently concluded an instructive and successful End-of-Phase-2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) and have confirmed that we are agreement with the FDA on key elements of the randomized Phase 3 segment of RINGSIDE," said Ken Berlin, President and Chief Executive Officer of the Company. "The most recent data from Phase 2 of RINGSIDE presented at ASCO (Free ASCO Whitepaper) were encouraging and we look forward to presenting a further update at the ESMO (Free ESMO Whitepaper) congress in October this year. We are excited, also, to expand our clinical pipeline through the recently announced proposed merger with Biosight. The addition of Biosight’s lead asset aspacytarabine (BST-236) fits with our strategic vision and core competencies. Along with the merger, we have plans to strengthen our balance sheet and execute our clinical plans, with the goal of creating sustainable value for patients and shareholders."

Second Quarter 2023 and Recent Business Highlights

End-of-Phase 2 meeting with FDA regarding AL102 for desmoid tumors: Ayala confirmed that it is in agreement with the FDA on key elements of the randomized Phase 3 segment of RINGSIDE, evaluating AL102 in desmoid tumors. The FDA accepted the selection of the 1.2 mg once daily dose for Phase 3 and the completed and proposed clinical pharmacology plan. Enrollment in Phase 3 commenced in November 2022, and is continuing globally as planned, with target enrollment of 156 patients. The primary endpoint is progression free survival with secondary endpoints including objective response rates, duration of response, and patient-reported quality of life measures.
Updated results from Phase 2 of RINGSIDE study presented at 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting: ASCO (Free ASCO Whitepaper) poster highlighted 50% partial response and 100% disease control rates in evaluable desmoid tumor patients treated with AL102 1.2 mg once daily (the selected Phase 3 dose) at a cut off date of January 3, 2023. Tumor responses, volume and T2 signal reduction were observed earlier in the 1.2 mg once daily group, with deeper and sustained treatment responses. AL102 continues to be generally well tolerated and has a manageable safety profile.
Definitive merger agreement with Biosight: Ayala entered into a definitive agreement with Biosight Ltd., pursuant to which, Ayala will combine with Biosight in an all-stock transaction. Upon completion of the proposed merger, the combined company will operate under the name Ayala Pharmaceuticals, Inc., and will continue to trade on the OTCQX under Ayala’s current ticker symbol ("ADXS"). The combined company will work to advance a portfolio of oncology assets, with a primary focus on Ayala’s AL102, and Biosight’s aspacytarabine (BST-236). The transaction is expected to close near the end of the third quarter of 2023, subject to regulatory and other conditions including approval of Biosight stockholders.
Upcoming Milestones

ESMO poster presentations on AL102 and AL101: Updated results from Phase 2 of RINGSIDE evaluating AL102 in desmoid tumors and final results from the ACCURACY trial evaluating AL101 in patients with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) have been selected for presentation at the European Society for Molecular Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, to be held in Madrid, Spain 20-24 October 2023.
Data from Phase 1 trial of ADXS-504: ADXS-504 is being evaluated in a Phase 1 investigator-sponsored study at Columbia University in patients with biochemically recurrent (early) prostate cancer. Readout of initial clinical and PSA data are expected in 2023.
Gain clarity on path for future development plan for AL101 in recurrent/metastatic adenoid cystic carcinoma (R/M ACC), expected in 2023.
Consolidated Financial Results for the Second Quarter Ended June 30, 2023

Cash position On June 30, 2023, the Company’s consolidated cash and cash equivalents position was $7.1 million.

Revenue Collaboration revenue was $9 thousand in the three months ended June 30, 2023, compared with $38 thousand in the comparable period of 2022.

R&D Expenses Research and development expenses were $5.7 million for the three months ended June 30, 2023 compared to $5.6 million for the three months ended June 30, 2023.

G&A Expenses General and administrative expenses were $2.7 million for the three months ended June 30, 2023 compared to $2.3 million for the three months ended June 30, 2023.

Net Loss The net loss for the three months ended June 30, 2023 was approximately $8.7 million or ($1.82) per share based on approximately 4.8 million weighted average shares outstanding. This compares with a net loss for the three months ended June 30, 2022 of approximately $8.1 million or ($2.83) per share based on approximately 2.9 million weighted average shares outstanding.

For further details on the Company’s financial results, including results for the six-month period ended June 30, 2023, refer to our quarterly report on Form 10-Q for the quarter ended June 30,2023, filed with the Securities and Exchange Commission.

On August 10, 2023 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the second quarter ended June 30, 2023, and announced a corporate reorganization to reduce expenses and extend its cash runway (Press release, Atreca, AUG 10, 2023, View Source [SID1234634180]). As part of the reorganization, Atreca will be undertaking cost-saving measures, including suspending development of ATRC-101 and reducing its workforce by approximately 40%. Going forward operations will focus on advancing current preclinical antibody-drug conjugate (ADC) candidates, including APN-497444, while preserving core discovery capabilities.

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"In order to extend our cash runway and focus on our preclinical ADC development efforts, we are suspending development of ATRC-101," said John Orwin, Chief Executive Officer of Atreca. "We are proud of our work in advancing ATRC-101 into the clinic and are encouraged by the activity and safety profile that we observed, validating the ability of our discovery platform to generate novel, tumor-targeting product candidates. Nevertheless, given both development requirements and financial considerations, we believe that the best path forward for the asset is with a larger partner, and as a result, we are suspending development and evaluating potential out-licensing opportunities. Our preclinical ADC pipeline, led by APN-497444, will continue to advance, and we are working towards declaring a clinical candidate from this program in the coming months."

"We have also made the difficult decision to reduce our headcount by approximately 40%," continued Mr. Orwin. "Given the talent and dedication of our workforce, this decision was not made lightly. We believe, however, that it is a necessary step to ensure we have the capital to execute on our mission to deliver novel therapeutics to patients in need. I’d like to thank those impacted for their important contributions to Atreca, including discovering and advancing both ATRC-101 and APN-497444."

Recent Developments and Highlights

APN-497444 (‘444), an Atreca-discovered antibody targeting a novel, tumor-specific glycan, continues to advance. ‘444 displays uniform and tumor-selective binding with high target prevalence in colorectal cancer and exhibits compelling pre-clinical anti-tumor activity and initial safety when weaponized as an ADC. Atreca expects to nominate a clinical candidate from the program in 2023 and is targeting an IND submission in late 2024/early 2025.
The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for MAM01/ATRC-501 submitted by the Gates Medical Research Institute (Gates MRI). Gates MRI plans to initiate its Phase 1 trial based in the US later this year, followed by a trial in Sub-Saharan Africa. Atreca retains commercial rights in the U.S., Europe and parts of Asia, and potential product development opportunities in those regions include prophylaxis for those traveling to malaria endemic regions.
Second Quarter 2023 Financial Results

As of June 30, 2023, cash and cash equivalents and investments totaled $38.5 million.
Research and development expenses for the three months ended June 30, 2023, were $12.9 million, including non-cash stock-based compensation expense of $1.2 million.
General and administrative expenses for the three months ended June 30, 2023, were $6.8 million, including non-cash stock-based compensation expense of $1.7 million.
Atreca reported a net loss of $19.2 million, or basic and diluted net loss per share attributable to common stockholders of $0.49, for the quarter ended June 30, 2023.