On May 15, 2023 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that it has commenced an underwritten public offering of $50.0 million of shares of its common stock (Press release, Coherus Biosciences, MAY 15, 2023, View Source [SID1234631708]). In addition, Coherus expects to grant the underwriters a 30-day option to purchase up to an additional $7.5 million of shares of its common stock at the public offering price, less the underwriting discount. All of the shares of common stock to be sold in the offering will be offered by Coherus. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

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Coherus intends to use substantially all of the net proceeds from this offering for general corporate purposes, including the cost of manufacturing clinical and commercial supplies of product candidates and products. Coherus may also use a portion of the net proceeds from this offering, together with existing cash, cash equivalents and marketable securities, to in-license, acquire or invest in complementary businesses, technologies, products or assets. If there are any remaining net proceeds from this offering, Coherus intends to use them for working capital and other general corporate purposes.

J.P. Morgan and Citigroup will act as co-lead book-running managers for the offering. Mizuho will act as lead manager for the offering.

A shelf registration statement (including a base prospectus) relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on November 17, 2022. This offering may be made solely by means of a prospectus supplement and the accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, electronic copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained by contacting J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: (866) 803-9204, email: [email protected] or Citigroup Global Markets Inc. c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: (800) 831-9146.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 15, 2023 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported its financial results for the quarter ended March 31, 2023 and provided a clinical update of its anti-cancer drug candidate currently in development for the treatment of primary and metastatic brain and CNS cancer (Press release, CNS Pharmaceuticals, MAY 15, 2023, View Source [SID1234631707]).

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"Over the course of the first quarter, our team has continued its flawless operational execution of our potentially pivotal study witnessed by our recent enrollment update boasting 100 patients now dosed in this global clinical trial. Importantly, we continue to plan for success as we approach our highly anticipated interim analysis for our ongoing Berubicin trial for GBM, expected in the third quarter of this year. In addition to the tremendous progress we have achieved on the clinical front, we significantly bolstered our Board of Directors with deep industry expertise with the appointments of Faith Charles as Chair and most recently, Dr. Bettina Cockroft as an independent director," commented John Climaco, CEO of CNS Pharmaceuticals. "We remain vigilant in our committment to all stakeholders, especially providing a much-needed potential treatment option for the GBM community."

Recent Corporate Highlights

· Appointed Bettina M. Cockroft, M.D., M.B.A., to Board of Directors, bringing over 30 years of significant biopharmaceutical industry experience and proven clinical development and operational expertise across multiple therapeutic disciplines worldwide.
· Appointed Faith L. Charles, JD as Chair of the Board of Directors, bringing over 30 years of deep life sciences industry experience with a wide range of expertise in corporate governance, capital markets, licensing and strategic collaborations.

Recent Clinical Achievements

· Announced enrollment of over 100 patients; The Company has opened 45 clinical trial sites of the 60 sites selected across the U.S., Italy, France, Spain, and Switzerland.
· Received approval from Competent Authority and Central Ethics Committee in Italy for GBM potentially pivotal study.
· Enrolled first patients in Switzerland and Spain.

Upcoming Expected Milestones

· Report results of interim analysis of potentially pivotal trial of Berubicin expected during the third quarter of 2023.
· Complete enrollment in potentially pivotal clinical trial for GBM.
· Report topline results.

Summary of Financial Results for the First Quarter 2023

The net loss for the three months ended March 31, 2023 was approximately $4.9 million compared to approximately $3.2 million for the comparable period in 2022. The change in net loss is primarily attributable to an increase in research organization ("CRO") expenses related to continued progress with the Company’s potentially pivotal clinical trial of Berubicin, a credit to research and development expense in the prior year period for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, as well as increases in legal and professional fees and other expenses.

The Company reported research and development expenses of $3.6 million for the three months ended March 31, 2023 compared to approximately $1.9 million for the comparable period in 2022. The increase in research and development expenses during the period were mainly attributed to the timing of CRO expenses related to continued progress with the Company’s potentially pivotal clinical trial of Berubicin.

General and administrative expense was approximately $1.4 million for the three months ended March 31, 2023 compared to approximately $1.3 million for the comparable period in 2022. The increase in general and administrative expense was mainly attributable to increases of approximately $75,000 for legal and professional expenses, $37,000 in advertising and marketing, $18,000 in board compensation, $19,000 in travel expenses and $15,000 in other expenses, which were offset by an decrease of approximately $47,000 in stock compensation and $18,000 in insurance expenses.

As of March 31, 2023, the Company had cash of approximately $5.1 million and working capital of approximately $3.0 million.

Subsequent to March 31, 2023, the Company:

· Issued 659,677 shares of common stock under its At-The-Market ("ATM") facility for net proceeds of $1,969,107 (an average price $3.08 per share before a 3% fee to the agent); and
· Had 238,958 Investor Warrants (exercisable into one share of common stock at a price per share of $3.03) exercised by investors in the financing completed on November 30, 2022 for net proceeds of $724,043.

The Company’s current expectation is that the cash on hand, including the issuances subsequent to the first quarter, is sufficient to fund operations beyond the interim analysis and into the fourth quarter of 2023.

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