On May 15, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the first quarter ended March 31, 2023, and recent corporate highlights (Press release, Checkpoint Therapeutics, MAY 15, 2023, View Source [SID1234631706]).

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"The first quarter of 2023 began a transformative year for Checkpoint, with our January submission of a Biologics License Application ("BLA") for cosibelimab in patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC"), followed by the FDA’s acceptance of the BLA filing in March, in which they indicated that no potential filing review issues have been identified and that an advisory committee meeting to discuss the application is not currently planned," said James Oliviero, President and Chief Executive Officer of Checkpoint. "We continue to prepare for a potential commercial launch in 2024, while simultaneously progressing active discussions with multiple third parties to evaluate potential partnerships and other types of corporate development transactions."

Mr. Oliviero continued, "If approved, based on its compelling efficacy and safety profile, we believe cosibelimab has the potential to capture significant market share in this $1.6 billion U.S. market opportunity through positioning as a differentiated and possibly best-in-class treatment for patients with cutaneous squamous cell carcinoma."

Recent Corporate Highlights:

Checkpoint submitted a BLA to the FDA seeking approval of cosibelimab in January 2023. In March 2023, Checkpoint announced the FDA accepted the BLA filing for cosibelimab and set a Prescription Drug User Fee Act ("PDUFA") goal date of January 3, 2024. In its BLA filing acceptance letter, the FDA indicated that no potential filing review issues have been identified, and that an advisory committee meeting to discuss the application is not currently planned.
In February 2023, Checkpoint completed a registered direct offering priced at-the-market under Nasdaq rules and a concurrent private placement of two series of warrants to purchase Checkpoint common stock, for total gross proceeds of approximately $7.5 million.
In April 2023, Checkpoint completed another registered direct offering priced at-the-market under Nasdaq rules and a concurrent private placement of two series of warrants to purchase Checkpoint common stock, for total gross proceeds of approximately $6.1 million.
Financial Results:

Cash Position: As of March 31, 2023, Checkpoint’s cash and cash equivalents totaled $4.8 million, compared to $12.1 million at December 31, 2022, a decrease of $7.3 million. Subsequent to the end of the quarter, Checkpoint raised approximately $6.1 million of gross proceeds in a registered direct offering completed in April 2023.
R&D Expenses: Research and development expenses for the first quarter of 2023 were $15.8 million, compared to $14.7 million for the first quarter of 2022, an increase of $1.1 million. Research and development expenses for the first quarter of 2023 included $0.4 million of non-cash stock expenses, compared to $0.2 million for the first quarter of 2022.
G&A Expenses: General and administrative expenses for the first quarter of 2023 were $2.3 million, compared to $2.2 million for the first quarter of 2022, an increase of $0.1 million. General and administrative expenses for the first quarter of 2023 and 2022 both included $0.7 million of non-cash stock expenses.
Net Loss: Net loss attributable to common stockholders for the first quarter of 2023 was $10.5 million, or $0.89 per share, compared to a net loss of $16.8 million, or $1.98 per share, in the first quarter of 2022. Net loss for the first quarter of 2023 included $1.1 million of non-cash stock expenses, compared to $0.9 million for the first quarter of 2022.

On May 15, 2023 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, reported financial results for the first quarter ended March 31, 2023 and provided other recent corporate updates (Press release, Celcuity, MAY 15, 2023, View Source [SID1234631705]).

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"I am very pleased with the execution to date of our VIKTORIA-1 Phase 3 clinical trial enrollment activities at our trial sites. Our team is relentlessly focused and keeping us on track to deliver initial data in the second half of 2024," said Brian Sullivan, CEO and Co-Founder of Celcuity.

"The updated median progression free survival (mPFS) data for treatment-naïve HR+/HER2- advanced breast cancer patients we presented last week at the ESMO (Free ESMO Whitepaper) Breast Cancer Congress is very encouraging. The reported mPFS of 48.6 months compares very favorably to published data for available standards of care in this setting. In addition, the findings from the various nonclinical studies we presented at ASCO (Free ASCO Whitepaper)-GU and AACR (Free AACR Whitepaper) further highlight the benefit of inhibiting all Class I PI3K isoforms and MTOR1/MTORC2 and provide important input as we prioritize our clinical development plans."

First Quarter 2023 Business Highlights and Other Recent Developments

● Site activation and patient enrollment activities for the VIKTORIA-1 Phase 3 clinical trial remained on track to enable primary analysis of the PIK3CA WT sub-group in the second half of 2024. 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 February 2023, the Company presented data from nonclinical studies evaluating gedatolisib and various PI3K, AKT, and mTOR inhibitors in prostate cancer cell lines at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium. The studies demonstrated gedatolisib’s superior potency and efficacy relative to the various PI3K, AKT, and mTOR inhibitors, regardless of the cell lines’ PTEN or PI3K status.

● In April 2023, Celcuity presented a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting reporting results from nonclinical studies evaluating gedatolisib and various PI3K, AKT, mTOR inhibitors in endometrial, ovarian and cervical cancer cell lines. The studies demonstrated 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 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. The presentation reported efficacy and safety data in treatment-naïve patients with HR+/HER2- advanced breast cancer enrolled in Escalation Arm A and Expansion Arm A. Median progression-free survival (mPFS) and median duration of response (mDOR) data was updated as of March 16, 2023. For treatment-naïve patients in Escalation Arm A (n=11) and Expansion Arm A (n=30), median PFS was 45.8 months and 48.6 months, respectively. When treatment-naïve patients from both arms were combined (n=41), mPFS was 48.6 months and mDOR was 46.9 months. Median PFS in Expansion Arm A had not yet been reached when this data was reported at the San Antonio Breast Cancer Symposium last December.

● 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.

First Quarter 2023 Financial Results

Unless otherwise stated, all comparisons are for the first quarter ended March 31, 2023, compared to the first quarter ended March 31, 2022.

Total operating expenses were $12.5 million for the first quarter of 2023, compared to $7.5 million for the first quarter of 2022. Net cash used in operating activities for the first quarter of 2023 was $12.9 million, compared to $5.9 million for the first quarter of 2022.

Research and development (R&D) expenses were $11.3 million for the first quarter of 2023, compared to $6.7 million for the first quarter of 2022. The approximately $4.6 million increase was primarily the result of activities supporting the VIKTORIA-1 pivotal trial.

General and administrative (G&A) expenses were $1.3 million for the first quarter of 2023, compared to $0.8 million for the first quarter of 2022. The approximately $0.5 million increase was the result of non-cash based compensation and fees associated with being a public company.

Net loss for the first quarter of 2023 was $11.9 million, or $0.55 loss per share, compared to a net loss of $7.9 million, or $0.53 loss per share, for the first quarter of 2022. Non-GAAP adjusted net loss for the first quarter of 2023 was $10.2 million, or $0.47 loss per share, compared to non-GAAP adjusted net loss for the first quarter of 2022 of $7.0 million, or $0.47 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 March 31, 2023, Celcuity had cash, cash equivalents and short-term investments of $157.5 million.

On May 15, 2023 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported updated data from CANaspire, its Phase 1/2 clinical trial of BBP-812, an investigational intravenous (IV) adeno-associated virus serotype 9 (AAV9) gene therapy for the treatment of Canavan disease, will be presented at the 2023 American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, taking place in Los Angeles, CA on May 16 – 20, 2023 (Press release, BridgeBio, MAY 15, 2023, View Source [SID1234631704]).

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Additionally, members of BridgeBio leadership, including Neil Kumar, CEO and founder, will be presenting on multiple panels discussing drug development and accelerated approval for gene therapy.

Oral presentation details:

Initial biomarker and clinical findings from the CANaspire Canavan disease gene therapy trial: Exploration of connections between NAA and disease severity
Presenter: Florian Eichler, M.D., director of the leukodystrophy service at Massachusetts General Hospital, Center for Rare Neurological Disease and lead CANaspire investigator
Session date/ time: Saturday, May 20 at 10:15 am – 12:00 pm PT
Presentation time: 11:15 am – 11:30 am PT
Location: Concourse Hall 150 & 151, Los Angeles Convention Center
Session title: Gene and cell therapy trials in progress
Abstract number: 358

Additional panel details:

Accelerated approval for cell and gene therapies
Date & time: Wednesday, May 17 at 9:00 am – 9:45 am PT
Panelist: Adora Ndu, Pharm.D., J.D., chief regulatory and interim legal officer of BridgeBio
Location: Room 515 AB, Los Angeles Convention Center

Venture capital in the gene and cell therapy space
Date & time: Friday, May 19 at 8:00 am – 9:45 am PT
Co-chair: Eric David, M.D., J.D., CEO of BridgeBio Gene Therapy
Panelist: Neil Kumar, Ph.D., founder and CEO of BridgeBio
Location: Concourse Hall 152 & 153, Los Angeles Convention Center

Evolution of genetic medicines: Navigating the challenges and synergies among therapeutic modalities
Date & time: Friday, May 19 at 10:15 am – 12:30 pm PT
Panelist: Eric David, M.D., J.D., CEO of BridgeBio Gene Therapy
Location: Room 411, Los Angeles Convention Center

Accelerate your drug development program in rare disease with robust natural history data: An evolving space
Session title: How to design a natural history study that regulators and clinicians support
Date & time: Friday, May 19 at 10:15 am – 12:00 pm PT
Panelist: Adam Shaywitz, M.D., Ph.D., chief medical officer at BridgeBio Gene Therapy
Location: Room 408 AB, Los Angeles Convention Center

On May 15, 2023 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive detection of early-stage lung cancer and other diseases of the lung, reported financial results for the three months ended March 31, 2023 (Press release, BioAffinity Technologies, MAY 15, 2023, View Source [SID1234631703]).

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Highlights from the first quarter of 2023 and subsequent weeks included:

Corporate and Commercial Highlights

● Appointed Michael Dougherty as Chief Financial Officer. Mr. Dougherty most recently served as CFO of Amazon’s Alexa commercial domains, where he was responsible for financial strategy over Alexa’s multibillion-dollar investments in AI-generated customer experiences.
● Engaged Havas Health & You and Trinity Life Sciences to create the branding and marketing strategy for CyPath Lung.
● Continued with the initial rollout of CyPath Lung to select test markets in Texas with encouraging user feedback and survey responses.
● Management rang the Nasdaq Stock Market closing bell on April 5 to commemorate the Company’s IPO in September 2022.

Research and Development Highlights

● Received Notice of Allowance from the U.S. Patent and Trademark Office for a patent titled "Porphyrin Compounds and Compositions Useful for Treating Cancer" for the targeted delivery of novel cancer treatments. This patent is owned by the Company’s wholly owned subsidiary OncoSelect Therapeutics and grants protection through 2037.
● Expanded geographic coverage for this OncoSelect Therapeutics patent to include issuance in Hong Kong, which joins the U.S., Australia, China and Mexico, with patent applications pending in Canada, the European Union, India and Japan.
● CyPath Lung clinical validation study results were published in Respiratory Research and demonstrated 92% sensitivity and 87% specificity in high-risk patients with nodules smaller than 20 millimeters or no nodules in the lung, with an area under the ROC curve of 94%.

● The article "Porphyrin-Modified Beads for Use as Compensation Controls in Flow Cytometry" was published in the peer-reviewed Journal of Visualized Experiments (JoVE) and describes the protocol for preparing porphyrin-labeled compensation beads to optimize the ability of CyPath Lung to detect early-stage lung cancer.
● Presented advancements in CyPath Lung at the Cleveland Clinic’s invitation-only fourth annual "Advances in Early Lung Cancer Detection" Symposium, which brings together global leaders in the field of lung cancer, including physicians, advocates and industry, to accelerate the development and implementation of new technologies and methods for early lung cancer detection.

Management Commentary

"Our first quarter results reflect our focus on positioning bioAffinity Technologies both financially and organizationally to achieve our most important near-term objective: expanding the commercial launch of CyPath Lung into additional markets to optimize our rollout for maximum success. Preliminary commercial results are encouraging, and with constructive initial feedback from physicians, we’re fine-tuning the CyPath Lung branding and marketing strategy. A survey of pulmonologists, internists and primary care physicians shows that they understand the need for a noninvasive, accurate lung cancer diagnostic and are receptive to including the test as part of their clinical decision-making for high-risk patients," bioAffinity President and Chief Executive Officer Maria Zannes said.

"CyPath Lung is currently commercially available as a laboratory developed test through our licensee, Precision Pathology Services. The launch of our pivotal clinical trial later this year is a critical step toward securing FDA clearance as a Class II in vitro diagnostic, which would enable us to market directly to U.S. physicians and their patients and facilitate dialogues with payers," Ms. Zannes added.

First Quarter Financial Results

Revenue for the first quarter of 2023 was $1,000, compared with no revenue for the prior-year period. Revenue is currently generated exclusively from royalties from the Company’s licensee, Precision Pathology Services, from sales of CyPath Lung as a laboratory developed test.

Research and development expenses were $370,000 for the first quarter of 2023, compared with $280,000 for the comparable period in 2022. The increase was primarily due to higher compensation costs from adding research personnel and higher R&D equipment costs.

Clinical development expenses were $20,000 for the first quarter of 2023, compared with $53,000 for the first quarter of 2022. The decline was primarily attributed to lower professional fees related to clinical strategy evaluation as the Company prepares to launch the CyPath Lung pivotal trial.

Selling, general and administrative expenses were $1.2 million for the first quarter of 2023, compared with $395,000 for the comparable period in 2022. The increase was primarily attributed to higher consulting, legal and professional fees incurred to comply with public company reporting requirements.

Net loss for the first quarter of 2023 was $1.5 million, or $0.18 per share, compared with a net loss of $1.5 million, or $0.55 per share, for the comparable period in 2022.

Cash and cash equivalents as of March 31, 2023, were $9.8 million, compared with $11.4 million as of December 31, 2022. bioAffinity Technologies believes that its available cash will be sufficient to fund planned operations for at least the next 12 months.

On May 15, 2023, Arcus Biosciences, Inc. ("Arcus") reported to have entered into an amendment ("Amendment No. 2") to its Option, License and Collaboration Agreement with Gilead Sciences, Inc. ("Gilead") dated May 27, 2020 (Filing, Arcus Biosciences, MAY 15, 2023, View Source [SID1234631701]). Pursuant to Amendment No. 2, Arcus will receive an upfront payment of $35 million and will initiate research programs against up to four targets jointly selected by the parties that are applicable to inflammatory diseases. Gilead may exercise an option to license each program at two separate, prespecified time points. If Gilead exercises its option at the earlier time point for the first two target programs, Arcus would be eligible to receive up to $420 million in option and milestone payments and tiered royalties for each optioned program. For any other option exercise by Gilead for the four target programs, the parties would have rights to co-develop and share global development costs and to co-commercialize and share profits in the United States for optioned programs.

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The foregoing is only a brief description of Amendment No. 2 and does not purport to be a complete description of its terms and is qualified in its entirety by reference to the amendment, which will be filed as an exhibit to Arcus’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2023.