On December 30, 2022, GT Biopharma, Inc. (the "Company") signed a purchase agreement (the "Purchase Agreement") with an institutional investor (the "Purchaser") for the issuance and sale, in a registered direct offering (the "Offering"), of 3,600,000 shares of the Company’s common stock, par value $0.001 per share (the "Shares"), pre-funded warrants to purchase up to 2,900,000 shares of the Company’s common stock (the "Pre-Funded Warrants"), and warrants to purchase up to an aggregate of 6,500,000 shares of the Company’s common stock (the "Common Warrants") (Filing, 8-K, GT Biopharma, JAN 4, 2023, View Source [SID1234625802]). The Common Warrants have an exercise price equal to $1.00, will be exercisable commencing six months following issuance, and will have a term of exercise equal to five years following the initial exercise date. The Pre-Funded Warrants have an exercise price of $0.0001 per Share, are immediately exercisable and can be exercised at any time after their original issuance until such Pre-Funded Warrants are exercised in full. The Shares and Common Warrants were sold at an offering price of $1.00 per Share and accompanying Common Warrant and the Pre-Funded Warrants and Common Warrants were sold at an offering price of $0.9999 per Pre-Funded Warrant and accompanying Common Warrant.

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The offering of the Shares, the Common Warrants, the Pre-Funded Warrants, the Shares that are issuable from time to time upon exercise of the Common Warrants and the Shares that are issuable from time to time upon exercise of the Pre-Funded Warrants (the "Offering") was made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-267870) (the "Form S-3") initially filed with the Securities and Exchange Commission (the "Commission") on October 13, 2022, and declared effective by the Commission on October 20, 2022.

H.C. Wainwright & Co., LLC ("Wainwright") acted as the Company’s exclusive placement agent in connection with the Offering. In connection with the Offering, the Company agreed to pay Wainwright a cash fee equal to $390,000, $35,000 for legal fees and expenses and up to $15,950 for clearing expenses. In addition, the Company has agreed to grant placement agent warrants to Wainwright to purchase up to 390,000 shares of Common Stock (the "Placement Agent Warrants"). The terms of the Placement Agent Warrants are substantially the same as the terms of the Common Warrants, except the Placement Agent Warrants will have an exercise price of $1.25 per share and will expire five years from the commencement of sales of the Offering.

Wainwright did not purchase or sell any of the Shares, the Common Warrants or the Pre-Funded Warrants and was not required to arrange the purchase or sale of any specific number of securities or dollar amount. The gross proceeds to the Company from the Offering were $6.5 million, before deducting placement agent fees and other offering expenses. The Company anticipates using the net proceeds from the Offering for general corporate purposes.

Pursuant to the Purchase Agreement, the Company agreed for a period of 60 days following the closing of the Offering not to issue, enter into an agreement to issue or announce the issuance or proposed issuance of the shares or any other securities convertible into, or exercisable or exchangeable for, shares. Such restriction does not apply to, in addition to certain customary exceptions, certain securities issuances, the issuance by the Company of equity or debt securities pursuant to acquisitions or strategic transactions approved by a majority of the Company’s disinterested directors, where not for the purpose of raising capital, or certain other compensatory issuances. The Company has also agreed for a period of one year following the closing date of the Offering not to (i) issue or agree to issue equity or debt securities convertible into, or exercisable or exchangeable for, shares at a conversion price, exercise price or exchange price which floats with the trading price of the shares or which may be adjusted after issuance upon the occurrence of certain events or (ii) enter into any agreement, including an equity line of credit, whereby the Company may issue securities at a future-determined price, subject to certain exceptions.

The Purchase Agreement contains customary representations and warranties, agreements and obligations, conditions to closing and termination provisions.

The foregoing descriptions of the Common Warrants, the Pre-Funded Warrants, the Placement Agent Warrants and the Purchase Agreement are qualified in their entirety by reference to the full text of the forms thereof, which are attached as Exhibits 4.1, 4.2, 4.3 and 10.1 hereto and incorporated by reference herein. A copy of the legal opinion and consent of Baker & McKenzie LLP, New York counsel to the Company, relating to the validity of the issuance and sale of the Shares, the Pre-Funded Warrants and Common Warrants is attached as Exhibit 5.1 hereto. A copy of the press release announcing the Offering and the Company’s entry into the Purchase Agreement is attached as Exhibit 99.1 hereto.

On January 4, 2023 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported an initial update on PRESERVE 3, an ongoing Phase 2, randomized, open-label study of first-line platinum-based chemotherapy and maintenance therapy with the immune checkpoint inhibitor, avelumab, administered alone, or in combination with trilaciclib, in patients with untreated, locally advanced or metastatic urothelial carcinoma (mUC) (Press release, G1 Therapeutics, JAN 4, 2023, View Source [SID1234625800]). Additional safety and efficacy data, including the primary endpoint of progression free survival (PFS), are anticipated in the middle of 2023.

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Initial Phase 2 Results

The confirmed objective response rate (ORR) per RECIST v1.1 was comparable between arms; ORR was 40.0% (n=18/45) and 46.7% (n=21/45) among evaluable patients in the trilaciclib and control arms, respectively. Longer-term follow-up is required to characterize additional anti-tumor endpoints including median duration of confirmed objective response and PFS, which is the primary endpoint of the study.

Safety is reviewed by the data monitoring committee (DMC) on an ongoing basis, and it has recommended that the study continue as planned. Though early, the safety and tolerability profile of trilaciclib administered prior to chemotherapy is generally consistent with that expected in patients treated with gemcitabine plus cisplatin/carboplatin and avelumab maintenance for previously untreated advanced or metastatic urothelial carcinoma.

"The immunomodulatory mechanism of action of trilaciclib lends itself to longer term anti-tumor efficacy endpoints like PFS, as opposed to shorter term response rate endpoints, as was noted in the Phase 2 trial in triple negative breast cancer (TNBC)," said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics. "We look forward to the results of the maintenance portion of this trial, particularly given the preclinical work that we have conducted showing the potential synergy of trilaciclib with checkpoint inhibitors – which we seek to validate clinically in this study with longer term duration of response and PFS data. We would expect to present these results at a medical meeting in 2023."

Trilaciclib, an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy to improve patient outcomes. Depending on the tumor type and the chemotherapy backbone, this mechanistic profile can drive patient benefits of myeloprotection and/or anti-tumor efficacy. Its mechanism of action of improving overall immune response by improving long term immune surveillance lends itself to longer term endpoints, such as progression free survival.

Phase 2 Trial Design

In this Phase 2 randomized, open-label study, 94 patients with mUC were randomized (1:1) to receive either gemcitabine/platinum chemotherapy (induction phase) followed by avelumab (checkpoint inhibitor) maintenance therapy (maintenance phase) or trilaciclib prior to gemcitabine/platinum chemotherapy followed by trilaciclib plus avelumab maintenance therapy.

The primary endpoint is to evaluate the anti-tumor efficacy of trilaciclib when combined with platinum-based chemotherapy and the checkpoint inhibitor avelumab maintenance therapy as measured by PFS during the overall study. Key secondary endpoints include evaluation of the anti-tumor efficacy of trilaciclib as measured by ORR, duration of objective response, PFS in the maintenance period, overall survival, and probability of survival at Month 16, and evaluation of the myeloprotective effects of trilaciclib on chemotherapy-induced myelosuppression.

About Bladder Cancer

Bladder cancer is the most common malignancy involving the urinary system and is the sixth most common cancer in the United States. The American Cancer Society estimates that approximately 84,000 new cases of bladder cancer will be diagnosed in the U.S. in 2021. Approximately 2.4% of the US population will be diagnosed with bladder cancer at some point during their lifetime; the average age at diagnosis is 73 years and it is rarely diagnosed in people less than 40 years of age. Urothelial carcinoma, also known as transitional cell carcinoma (TCC), urothelial bladder cancer, or urothelial cell carcinoma (UCC) of the urinary tract, is the most common type of bladder cancer in the U.S. and Europe, where it accounts for 90% of all bladder cancers. It also accounts for up to 15% of kidney cancers diagnosed in adults. The overall 5-year survival rate for metastatic urothelial carcinoma is approximately 5.5%, which has remained unchanged over the past 25 years.

On January 4, 2023 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that senior management will present at the upcoming 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023, at 8:15 a.m. Pacific Time (Press release, Coherus Biosciences, JAN 4, 2023, View Source [SID1234625797]). The presentation and Q&A session will be accessible via Webcast through a link posted on the Investor Events Calendar section of the Coherus website: View Source This webcast will be available for replay until February 10, 2023.

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On January 4, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported the submission of a Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for the approval of cosibelimab, its investigational anti-PD-L1 antibody, as a treatment for patients with metastatic cutaneous squamous cell carcinoma ("cSCC") or locally advanced cSCC who are not candidates for curative surgery or radiation (Press release, Checkpoint Therapeutics, JAN 4, 2023, View Source [SID1234625796]).

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"This is a major milestone for Checkpoint Therapeutics, representing our first submission of a marketing application for one of our investigational medications and furthering our evolution from a development-stage company to a fully integrated commercial organization to support the potential launch of cosibelimab," said James Oliviero, President and Chief Executive Officer of Checkpoint. "cSCC is the second most common type of skin cancer in the United States. While most cases involve localized tumors amenable to curative resection, approximately 40,000 cases will become advanced, and an estimated 15,000 people will die from their disease each year. Based on its compelling and differentiated product profile and the positive data generated to date, we believe cosibelimab has the potential to be an important treatment option for patients. Importantly, we continue to plan for cosibelimab to be positioned, upon regulatory approval, as potentially the first and only price disruptive PD-1/PD-L1 inhibitor in the U.S. market." Mr. Oliviero continued, "We want to thank the patients and their families, as well as the physicians and their research teams, who participated in our trial and contributed immensely to the advancement of cosibelimab."

The BLA submission is based on positive efficacy and safety results from Checkpoint’s ongoing registration-enabling, multi-regional, multicohort clinical trial evaluating cosibelimab administered as fixed doses of either 800 mg every two weeks or 1200 mg every three weeks in patients with selected recurrent or metastatic cancers, including pivotal cohorts in metastatic and locally advanced cSCC.

In January 2022, Checkpoint announced that the metastatic cSCC cohort met its primary endpoint, with cosibelimab demonstrating a confirmed objective response rate ("ORR") of 47.4% (95% CI: 36.0, 59.1) based on independent central review of 78 patients enrolled in the cohort using Response Evaluation Criteria in Solid Tumors version 1.1 ("RECIST 1.1") criteria. In June 2022, Checkpoint announced positive interim results from its locally advanced cSCC cohort, with cosibelimab demonstrating a confirmed ORR of 54.8% (95% CI: 36.0, 72.7) based on independent central review of 31 patients enrolled in the cohort, exceeding a clinically meaningful lower bound of the 95% two-sided confidence interval of 25%. Based upon interactions with the FDA, the BLA submission includes both the metastatic and locally advanced cSCC indications.

About Cutaneous Squamous Cell Carcinoma

Cutaneous squamous cell carcinoma is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1 million cases according to the Skin Cancer Foundation. While most cases are localized tumors amenable to curative resection, approximately 40,000 cases will become advanced, and an estimated 15,000 people will die from their disease each year. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear.

About Cosibelimab

Cosibelimab is a potential best-in-class, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 ("PD-L1") and blocks the PD-L1 interaction with the programmed death receptor-1 ("PD-1") and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained >99% target tumor occupancy to reactivate an antitumor immune response and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity ("ADCC") for potential enhanced efficacy in certain tumor types.

On January 4, 2023 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that members of its management team will present at the 41st Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Monday, January 9 at 3:00 pm PT.

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To access the live webcast of BridgeBio’s presentation, please visit the "Events & Presentations" page within the Investors section of the BridgeBio website at View Source A replay of the webcast will be available on the BridgeBio website for 90 days following the event.