Ensysce Biosciences Secures $1.7 Million Convertible Note Financing

On October 24, 2023 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC)(OTC PINK:ENSCW), a clinical-stage company applying transformative chemistry to improve prescription drug safety, reported that it has entered into a securities purchase agreement (the "SPA") with investors ("Investors") in the form of senior secured convertible notes (the "Notes") and warrants exercisable for Ensysce common stock (the "Warrants") in a private placement for an aggregate investment of $1.7 million (Press release, Ensysce Biosciences, OCT 24, 2023, View Source [SID1234636298]). The initial closing is expected to occur on or before October 26th and will raise $566,667, prior to fees and offering expenses.

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Dr. Lynn Kirkpatrick, CEO of Ensysce commented, "The financing is an excellent step allowing us to advance the clinical development of our highly unique TAAP and MPAR technologies. The funding will support the completion of a time of onset study and regulatory milestones for PF614, our lead product. We are very pleased that we were able to secure this additional funding to continue our progress and support our mission to deliver superior pain relief options while also providing abuse and overdose protection for opioid products."

The Notes, with total gross proceeds expected to be $1.7 million before fees and expenses, are convertible into shares of Ensysce common stock ("Common Stock") at a conversion price of $1.5675, the base price set at the time of execution of the SPA. The Notes have a maturity date of 6 months from the applicable closing date, will be issued with an original discount of 8% and will bear interest from date of issuance at 6% per annum. Monthly principal payments and interest in cash, or at the election of the purchaser in whole or in part which may occur at any time, in common stock will begin approximately 90 days after each respective closing. The Warrants to be issued at the initial closing will have the right to purchase up to 1,255,697 shares of common stock at an exercise price of $1.5675, the same as the conversion price, and are exercisable for five years following the date of issuance. An initial $566,667 of funding will be secured upon the initial closing upon satisfaction of certain conditions with a second closing of $1,133,333 under similar terms expected to occur upon satisfaction of certain conditions.

The conversion price for the Notes of $1.5675 and the exercise price for the Warrants of $1.5675 meet a minimum price requirement established by The Nasdaq Stock Market in connection with a potential issuance of 20% or more of the common stock of a public company or 20% or more of the voting power outstanding before the potential issuance. If the Company is not able to pay the principal and interest on the Notes when due and the Company needs to issue more shares of Common Stock or on terms different than those provided by the transaction documents, the Company might, in certain circumstances, be required to obtain stockholder approval before doing so.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful. This news release is being issued pursuant to and in accordance with Rule 135c under the Securities Act of 1933, as amended.

Coherus BioSciences Announces New Employment Inducement Grants

On October 24, 2023 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported that effective October 20, 2023, the compensation committee of the Company’s board of directors granted options to purchase an aggregate of 64,500 shares of the common stock of the Company to eight newly hired employees with a per share exercise price of $3.54, the closing trading price on the grant date (Press release, Coherus Biosciences, OCT 24, 2023, View Source [SID1234636297]).

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The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was approved by the Company’s board of directors in June 2016 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to enter into employment with the Company.

Chugai Announces 2023 3rd Quarter Results

On October 24, 2023 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the third quarter of fiscal year 2023 (Press release, Chugai, OCT 24, 2023, View Source [SID1234636296]).

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"In the third quarter of this year, we saw a continuation of the increase in both revenue and profits on a Core-basis from the first half. Sales increased both in domestic and overseas, driven by steady growth in new products such as Polivy, Vabysmo in Japan and by more than double-digit growth overseas in mainstay products Hemlibra and Alecensa. In R&D, Chugai made steady progress with in-house projects, mainly in late-stage development. An application for crovalimab in the treatment of paroxysmal nocturnal hemoglobinuria (PNH) was accepted for filing in the U.S. In addition, Alecensa achieved its primary endpoint in a global phase III study as a post-operative adjuvant therapy for early-stage ALK-positive non-small cell lung cancer (NSCLC), and Enspryng started a global phase III study for thyroid ophthalmopathy (TED), its fifth indication, and is being simultaneously developed in multiple diseases. We will continue to drive innovation to deliver innovative new drugs to patients as quickly as possible," said Dr. Osamu Okuda, Chugai’s President and CEO.

< Third Quarter Financial Results (Core results, January to September 2023) >

Chugai reported increased revenue and operating profit for the first nine months (Core-basis) compared to the same period of the previous fiscal year, consistent with second-quarter results.

Revenue increased in approximately 15% overall, with growth in both domestic and overseas sales and other revenue. Domestic sales increased by approximately 10%. In the oncology field, the growth was approximately 3% year-on-year due to the contribution of steady market penetration of new product Polivy, and the growth of mainstay product Tecentriq despite the impact of biosimilars and NHI drug price revisions on mature products such as Avastin and Herceptin. In the specialty field, sales increased by approximately 20%, driven by the penetration of new products Vabysmo for ophthalmology and Evrysdi for neuroscience, as well as the contribution of mainstay products Hemlibra for hemophilia and Enspryng for neuroscience, and the supply of Ronapreve for COVID-19 treatment to the government in the first quarter. Overseas sales increased by approximately 20% due to solid growth in exports of Hemlibra and Alecensa. Other revenue increased by approximately 13%, mainly due to the increase in royalties and profit-sharing income related to Hemlibra. Revenue on IFRS basis, including Non-Core items, decreased due to the one-time impact of the lump-sum income from the settlement agreement with Alexion Pharmaceuticals, Inc in the previous year.

Cost to sales ratio rose by 2.4% points year-on-year to 43.1%, mainly due to the impact of foreign exchange. Research and development expenses increased due to investments into drug discovery and early development, including the start of operation of Chugai Life Science Park Yokohama, and the progress of development projects. Also selling, general and administration expenses increased mainly due to various expenses. For other operating income (expense), an income of ¥16.3 billion was recorded, mainly due to the recognition of income from disposal of product rights and gain on sale of property, plant and equipment. As a result, Core operating profit totaled ¥340.5 billion (+13.9%).

The company also made good progress in research and development. Among our in-house projects, Actemra obtained approval for an additional indication of cytokine release syndrome induced by cancer therapy. Late-stage projects progressed including the U.S. Food and Drug Administration (FDA) acceptance of application of crovalimab for the treatment of PNH, and Alecensa achieving the primary endpoint in a global phase III study in patients with early-stage ALK-positive NSCLC, demonstrating the efficacy in adjuvant therapy for the first time as an ALK inhibitor. A global phase III study for Enspryng for treatment of TED, an ophthalmic disease, has been initiated. The drug is now being developed for four diseases simultaneously. As for projects in-licensed from Roche, Phesgo, a subcutaneous combination of Perjeta and Herceptin, which are standard treatments for HER2-positive breast cancer administered by intravenous injections, has received approval in Japan as a treatment for HER2-positive breast cancer and colorectal cancer. In addition, a new immune checkpoint inhibitor tobemstomig (RG6139) in solid tumors has entered the pipeline.

[2023 third quarter results]

Billion JPY 2023
Jan – Sep 2022
Jan – Sep % change
Core results
 Revenue 837.6 729.3 +14.8%
  Sales 742.1 644.7 +15.1%
  Other revenue 95.5 84.6 +12.9%
 Operating profit 340.5 299.0 +13.9%
 Net income 250.3 213.0 +17.5%
IFRS results*
 Revenue 837.6 821.2 +2.0%
 Operating profit 317.6 383.8 -17.2%
 Net income 234.3 271.9 -13.8%
*IFRS results in 2022 include non-Core items, such as the income and other related items, which totaled ¥90.7 billion associated with the settlement agreement between Chugai and Alexion Pharmaceuticals, Inc., which are excluded from the Core results Chugai adopts to manage recurring business activities.

[Sales breakdown]

Billion JPY 2023
Jan – Sep 2022
Jan – Sep % change
Sales 742.1 644.7 +15.1%
 Domestic sales 429.2 387.6 +10.7%
  Oncology 191.4 186.5 +2.6%
  Specialty 237.9 201.0 +18.4%
 Overseas sales 312.9 257.1 +21.7%
[Oncology field (Domestic) Top5-selling medicines]

Billion JPY 2023
Jan – Sep 2022
Jan – Sep % change
 Tecentriq 47.9 43.9 +9.1%
 Avastin 38.2 50.9 -25.0%
 Polivy 25.5 9.1 +180.2%
 Perjeta 24.6 23.5 +4.7%
 Alecensa 22.0 20.9 +5.3%
[Specialty field (Domestic) Top5-selling medicines]

Billion JPY 2023
Jan – Sep 2022
Jan – Sep % change
 Ronapreve* 81.2 60.8 +33.6%
 Hemlibra 40.5 35.2 +15.1%
 Actemra 32.2 31.2 +3.2%
 Enspryng 16.9 11.5 +47.0%
 Vabysmo 10.8 3.2 +237.5%
*Ronapreve has not been listed in the National Health Insurance (NHI) price list.

About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting Non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders.

Tecentriq plus Chemotherapy and Avastin Reduced the Risk of Disease Worsening or Death in Phase III study in People with Extensive-stage Small Cell Lung Cancer

On October 24, 2023 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that phase III BEAT-SC study, evaluating Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and platinum-based chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), met its primary endpoint of progression-free survival (PFS) (Press release, Chugai, OCT 24, 2023, View Source [SID1234636295]).

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"We are very pleased that Tecentriq plus chemotherapy and Avastin showed the improvement of PFS in difficult-to treat ES-SCLC. We will continue to consider ways to provide new value to patients," said Dr. Osamu Okuda, Chugai’s President and CEO.

Tecentriq in combination with Avastin and chemotherapy demonstrated a statistically significant reduction in the risk of disease progression or death (improvement of PFS) compared with Tecentriq and chemotherapy. Overall survival, one of the secondary endpoints, did not show a statistically significant prolongation at this interim analysis and the study will continue until the planned future analysis. Tecentriq in combination with Avastin and chemotherapy was tolerated, and no new safety signal of this combination were observed. The data will be presented at an upcoming medical meeting.

About small cell lung cancer (SCLC)
SCLC has the most aggressive course of any lung cancer and is characterized by rapid progression and poor survival. Due to its fast-growing nature, two-thirds of patients are diagnosed with extensive-stage (ES)-SCLC, when the cancer has already spread to other parts of the body.1

SCLC accounts for about 10~15%2 of all lung cancers, and is estimated to affect about 20,000 people in Japan.3

Tecentriq was the first cancer immunotherapy to show a survival benefit in ES-SCLC and was the first approved treatment option in 17 years in Japan.

About BEAT-SC study
BEAT-SC study is a randomised, placebo-controlled and double-blinded global phase III study evaluating Tecentriq (atezolizumab) plus Avastin (bevacizumab) and chemotherapy versus Tecentriq and chemotherapy alone as an initial (first-line) treatment in 330 people with extensive-stage small cell lung cancer. Primary endpoint is progression-free survival. Secondary endpoints include overall survival, response rate and safety. This study was conducted in Japan and China.

About combination of Tecentriq and Avastin
The combination of Tecentriq and Avastin may improve cancer immunity against various types of cancer. The anti-VEGF inhibitory activity of Avastin is related to its immunomodulatory activity, in addition to its known anti-angiogenic activity.4-7 Avastin may also improve the immunosuppressive tumor microenvironment.8 The T-cell-mediated effect of Tecentriq on cancer cells may be enhanced by combining Avastin with VEGF-mediated immunosuppression.9-17

Trademarks used or mentioned in this release are protected by law.

Sources

ASCO Cancer.net. Lung Cancer – Small Cell (View all). Available from: View Source Accessed September 2023.
Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, et al. Changing epidemiology of small cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol 2006;24(28):4539-44.
Japanese Society of Medical Oncology/New Clinical Oncology Version 5.0 (Nankodo) (Japanese only)
Ferrara N, et al. Nat Rev Drug Discov, 2004; 3(5): 391-400.
Hegde PS. et al.: Semin Cancer Biol 2018; 52 (Pt 2): 117-124.
Gabrilovich DI. et al.: Nat Med 1996; 2(10):1096-1103.
Oyama T. et al.: J Immunol 1998; 160(3): 1224-1232.
Huang Y, et al.: Cancer Res. 2013 May 15;73(10):2943-8.
Goel S. et al.: Physiol Rev 2011; 91(3): 1071-1121.
Motz GT. et al.: Nat Med 2014; 20(6): 607-615.
Hodi FS. et al.: Cancer Immunol Res 2014; 2(7): 632-642.
Wallin JJ. et al.: Nat Commun 2016; 7: 12624.
Zitvogel L, et al. Immunity, 2013; 39(1): 74-88.
Gabrilovich DI., Nagaraj S.: Nat Rev Immunol 2009; 9(3): 162-174.
Roland CL. et al.: PLoS One 2009; 4(11): e7669.
Facciabene A. et al.: Nature 2011; 475(7355): 226-230.
Voron T. et al.: J Exp Med 2015; 212(2): 139-148.

Cellectar Biosciences to Announce Third Quarter Earnings Results and Host a Conference Call on Thursday, November 2, 2023

On October 24, 2023 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of targeted drugs for the treatment of cancer, reported that the company will report its financial results for the three months ended September 30, 2023 on Thursday, November 2, 2023 (Press release, Cellectar Biosciences, OCT 24, 2023, View Source [SID1234636294]). Management will also host a conference call with investors to discuss financial results and provide an overview focused on the Waldenstrom’s macroglobulinemia market and its lead product candidate, iopofosine I 131, at 8:30 am Eastern Time. Details for the call are as follows:

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Conference call & Webcast Details:
Date: Thursday, November 2
Time: 8:30 am Eastern Time
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Webcast: Click HERE
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