On March 24, 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases, reported that new interim data from 2nd line NSCLC patients (Part B) of its phase II TACTI-002 trial has been published in an abstract today in advance of ESMO (Free ESMO Whitepaper)’s European Lung Cancer Congress (ELCC) 2022. ELCC 2022 will now be taking place in a virtual only format from 30 March 2022 to 2 April 2022 (Press release, Immutep, MAR 24, 2022, View Source [SID1234610980]).

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Title: Results of a phase II study investigating eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in 2nd line PD-1/PD-L1 refractory metastatic non-small cell lung carcinoma pts
Abstract: Available at
View Source conference/ELCC 2022_TACTI-002 Part B_Abstract_Final.pdf
The related poster presentation with new and updated data that are not part of the abstract will now be released by ELCC on 29 March 2022 at 12:00 noon, CEST and will subsequently be made available on Immutep’s website at www.immutep.com.

About the TACTI-002 Trial

TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of eftilagimod alpha (efti) with MSD’s KEYTRUDA (pembrolizumab) in patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in study centres across Australia, Europe, and the US.

Patients participate in one of the following:

Part A – first line Non-Small Cell Lung Cancer (NSCLC), PD-X naïve – given the promising results of the first two stages of Part A, an expansion stage with additional patients was commenced in November 2020 to assist with trial design in subsequent late-stage settings

Part B – second line NSCLC, PD-X refractory

Part C – second line Head and Neck Squamous Cell Carcinoma (HNSCC), PD-X naïve

TACTI-002 is an all-comer study in terms of PD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC and HNSCC.

On March 24, 2022 Apellis Pharmaceuticals, Inc., (Nasdaq:APLS), a global biopharmaceutical company and leader in complement, reported the pricing of its underwritten public offering of 7,446,809 shares of its common stock at a public offering price of $47.00 per share, for total gross proceeds of $350 million, before deducting underwriting discounts and commissions and expenses payable by Apellis (Press release, Apellis Pharmaceuticals, MAR 24, 2022, View Source [SID1234610960]). All of the shares in the offering are being sold by Apellis. In addition, Apellis has granted the underwriters a 30-day option to purchase up to 1,117,021 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on March 28, 2022, subject to customary closing conditions.

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J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC and Evercore Group L.L.C. are acting as joint book-running managers for the offering. Raymond James & Associates, Inc. is acting as lead manager and Oppenheimer & Co. Inc. and Robert W. Baird & Co. Incorporated are acting as co-managers for the offering.

The shares are being offered by Apellis pursuant to an automatically effective shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on January 7, 2020. This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the final 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, by telephone at 866-803-9204, or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, 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 March 24, 2022 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create new product candidates that address unmet medical needs, reported the pricing of its offering of US$500,000,000 aggregate principal amount of 2.25% convertible senior notes due 2028 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Ascendis Pharma, MAR 24, 2022, View Source [SID1234610956]). The issuance and sale of the notes are scheduled to settle on March 29, 2022, subject to the satisfaction of customary closing conditions. Ascendis Pharma also granted the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date the notes are first issued, up to an additional US$75,000,000 aggregate principal amount of notes.

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The notes will be senior, unsecured obligations of Ascendis Pharma and will accrue interest at a rate of 2.25% per annum, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on October 1, 2022. The notes will mature on April 1, 2028, unless earlier redeemed or converted. At any time before the close of business on the second scheduled trading day immediately before the maturity date, noteholders may convert their notes at their option into Ascendis Pharma’s ordinary shares represented by American Depositary Shares (the "ADSs") (each representing one of Ascendis Pharma’s ordinary shares as of the date of this release), together, if applicable, with cash in lieu of any fractional ADS, at the then-applicable conversion rate. The initial conversion rate is 6.0118 ADSs per US$1,000 principal amount of notes, which represents an initial conversion price of approximately US$166.34 per ADS. The initial conversion price represents a premium of approximately 42.5% over the last reported sale price of US$116.73 per ADS on March 24, 2022. The conversion rate and conversion price will be subject to adjustment upon the occurrence of certain events.

The notes will be optionally redeemable, in whole or in part (subject to certain limitations), for cash at Ascendis Pharma’s option at any time, on or after April 7, 2025, but only if the last reported sale price per ADS exceeds 130% of the conversion price for a specified period of time. In addition, the notes will be optionally redeemable, in whole and not in part, at Ascendis Pharma’s option at any time in connection with certain changes in tax law. The optional redemption price will be equal to the principal amount of the notes to be optionally redeemed, plus accrued and unpaid interest, if any, to, but excluding, the optional redemption date.

If a "fundamental change" (as defined in the indenture for the notes) occurs, then, subject to a limited exception, noteholders may require Ascendis Pharma to redeem their notes for cash. The fundamental change redemption price will be equal to the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the applicable fundamental change redemption date.

Ascendis Pharma estimates that the net proceeds from the offering will be approximately US$485.0 million (or approximately US$557.9 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses. Ascendis Pharma intends to use approximately US$116.7 million of the net proceeds from the offering to repurchase 1,000,000 ADSs in privately negotiated transactions effected through one of the initial purchasers or its affiliate, as Ascendis Pharma’s agent. These repurchases, and any other repurchases of the ADSs or ordinary shares, may increase, or reduce the size of a decrease in, the trading price of the ADSs and ordinary shares, and repurchases executed concurrently with the pricing of the offering may have affected the initial terms of the notes, including the initial conversion price. Ascendis Pharma intends to use the remaining net proceeds to support the commercialization and further development of TransCon hGH, to fund pre-commercialization activities and clinical development of TransCon PTH, clinical development of its other endocrinology rare disease programs and its oncology programs, including TransCon PTH, TransCon CNP, TransCon TLR7/8 Agonist and TransCon IL-2 β/γ, to identify and progress development of new product candidates, and for working capital and other general corporate purposes.

The offer and sale of the notes, the ADSs issuable upon conversion of the notes and the ordinary shares represented by such ADSs have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes, such ADSs and such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes, the ADSs issuable upon conversion of the notes or the ordinary shares represented by such ADSs, nor will there be any sale of the notes, such ADSs or such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

On March 24, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with cancer, reported that financial results for the quarter and full year ended December 31, 2021 (Press release, Processa Pharmaceuticals, MAR 24, 2022, View Source [SID1234610951]). Management is hosting an earnings call today at 4:30 p.m. ET.

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The fourth quarter and full year 2021 was marked by meaningful corporate, financial and clinical progress.

2021 and early 2022 Highlights:

Agreed to acquire Cancer Prevention Pharmaceuticals, Inc. (CPP) setting the stage for a combined entity with an expanded pipeline addressing an estimated $5 billion aggregated market opportunity upon closing.
Initiated our ASPIRE trial – a global, randomized, double-blind, placebo controlled Phase II/III clinical trial of SBP-101 in combination with Gemcitabine and Nab-Paclitaxel versus Gemcitabine, Nab-paclitaxel and placebo in patients with untreated metastatic pancreatic ductal adenocarcinoma.
Announced a new development program in Ovarian Cancer expected to start in the first half 2022 as the result of positive preclinical data supporting the activity of SBP-101 in ovarian cancer cell lines.
Abstracts for SBP-101 were accepted for poster presentations at both the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January 2022 and the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2021; Median overall survival of 12.53 months for the phase 1 first line metastatic pancreatic trial reached shortly after the January poster presentation.
Announced issuance of key U.S. Patent for claims of a novel, more efficient, manufacturing process for the production of SBP-101.
Closed a $10.0 million bought deal public offering of common stock on July 2, 2021.
Joined the Russell Microcap Index.
Formed a research agreement with the Johns Hopkins University School of Medicine to further development of Panbela’s investigative agent SBP-101, including activity in cell lines outside of pancreatic cancer, biomarkers informing diagnostics and potential combination with checkpoint inhibitors.
"2021 and this year to date has been a transformative period of significant value creation for Panbela. Most recently, we entered into a definitive agreement to acquire CPP. The combined company will have an expanded pipeline addressing an estimated $5 billion aggregate market opportunity," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. A few highlights of the transaction include adding a lead asset with a fully funded registration trial targeting familial adenomatous polyposis (FAP) that is scheduled to begin this year. The acquisition also adds an ongoing Phase III trial, the PACES trial, in colon cancer survivors that is funded by National Cancer Institute in collaboration with the Southwest Oncology Group (SWOG). Additionally, CPP has clinical trials in neuroblastoma, gastric cancer, and early-onset type-1 diabetes underway, each in collaboration with various cooperative groups.

"Organically, Panbela has advanced our pancreatic cancer program into a Phase II/III trial. Due to its rigor, we are optimistic that the ASPIRE trial results, if positive, could support our registration efforts. Additionally, we’ve expanded SBP-101 into ovarian cancer based on positive preclinical results. We also completed pre-clinical work for our neoadjuvant investigator-initiated trial (IIT). Through pending M&A and organic execution, Panbela is well positioned to treat more patients and increase stockholder value," continued Dr. Simpson.

Upcoming Milestones:

For the first half of 2022, we expect to announce:

Satisfaction of conditions and closing the CPP transaction
First patient enrolled in our ASPIRE trial as well as expansion outside the US
We will host a Research call to review the ovarian cancer data and ovarian cancer treatment standards
Availability of Final Data – Phase I first- line metastatic pancreatic cancer
Initiation of SBP-101 development efforts in ovarian cancer
Also, during the second half of 2022, we expect to announce the opening of the Neoadjuvant Pancreatic Cancer IIT. With the expected closing of the CPP transaction, we anticipate that additional milestones for 2022 will reflect the increased flow of planned development activity and data.

Fourth Quarter ended December 31, 2021 Financial Results

General and administrative expenses were $1.3 million in the fourth quarter of 2021, compared to $0.9 million in the fourth quarter of 2020. The change is due to expenses, including legal and financial advisory fees, associated with the acquisition of CPP.

Research and development expenses were $2.0 million in the fourth quarter of 2021, compared to $0.7 million in the fourth quarter of 2020. The change is due primarily to an increase in spending on our clinical studies as we prepared to launch the ASPIRE clinical trial, as well as manufacturing expenses for product and placebo required for this trial.

Net loss in the fourth quarter of 2021 was $3.5 million, or $0.26 per diluted share, compared to a net loss of $0.9 million, or $0.09 per diluted share, in the fourth quarter of 2020.

Total cash was $11.9 million as of December 31, 2021. Total current assets were $12.3 million and current liabilities were $2.7 million as of the same date. The company had no debt as of December 31, 2021.

Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

Webcast replay: Webcast: View Source

About: SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma, ovarian cancer and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 12.53 months which is now final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source

On March 24, 2022 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC)(OTC PINK:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety and performance with a focus on reducing abuse and overdose while providing relief for those with severe pain, reported plans to release fourth quarter and full year 2021 financial results after close of market on Thursday, March 31, 2022 (Press release, Ensysce Biosciences, MAR 24, 2022, View Source [SID1234610949]).

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Corporate Update Conference Call

Management will host a corporate update conference call on Wednesday, April 6, 2022, at 11:00 a.m. Eastern time. The call will conclude with Q&A from participants.

Please dial in at least 10 minutes before the start of the call to ensure timely participation.

A playback of the call will be available through May 6, 2022 on Ensysce’s Investor Relations website at ir.ensysce.com.