On January 30, 2024 Palatin Technologies, Inc. (NYSE American: PTN) ("Palatin" or the "Company"), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, reported that it has entered into a definitive agreement with healthcare-focused institutional investors for the issuance and sale of an aggregate of 1,831,503 shares of its common stock, at a purchase price of $5.46 per share of common stock (Press release, Palatin Technologies, JAN 30, 2024, View Source [SID1234639785]). Palatin has also agreed to issue in a private placement warrants to purchase up to an aggregate of 1,831,503 shares of common stock at an exercise price of $5.46 per share. The warrants will become exercisable on the six months anniversary of the closing date and will expire on the date that is four years after the closing date.

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H.C. Wainwright & Co. is acting as exclusive placement agent for the offering.

The closing of the offering is expected to occur on or about February 1, 2024, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $10 million. Palatin intends to use the net proceeds of this offering for general corporate purposes.

The shares of common stock described above (excluding the warrants and the shares of common stock underlying the warrants) are being offered by Palatin pursuant to a shelf registration statement on Form S-3 (File No. 333-262555) that was previously filed with the Securities and Exchange Commission ("SEC") on February 7, 2022, and subsequently declared effective on September 26, 2022. The offering of shares of common stock to be issued in the registered direct offering is being offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying base prospectus relating to, and describing the terms of, the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the registered direct offering, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at [email protected].

The warrants described above will be issued in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying such warrants, will not be registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock, upon issuance, may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, 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 prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On January 30, 2024 MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and innovative bioprocessing applications, and Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, reported the signing of a strategic platform license (SPL) (Press release, Wugen, JAN 30, 2024, View Source [SID1234639754]).

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Under the terms of the agreement, Wugen gains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation technology and ExPERT platform. In return, MaxCyte will receive annual license fees and program-related revenue.

Wugen is developing the next generation of off-the-shelf memory natural killer (NK) and CAR-T cell therapies for cancer. The company’s investigational cell therapies originate from healthy donors and are further engineered to enhance their function of eliminating cancer cells. Wugen’s lead program is evaluating WU-CART-007, a CD7 targeted CAR-T cell therapy, in a global Phase 1/2 clinical trial for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL) in adolescent and adult patients. WU-CART-007 has received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the U.S. Food and Drug Administration for the treatment of R/R T-ALL/LBL. Additional information is available on clinicaltrials.gov, identifier NCT# 04984356.

"As WU-CART-007 is transferred onto the ExPERT platform and continues to progress in the clinic, we are able to support efficient and seamless expansion to large-scale manufacturing," said Maher Masoud, President and CEO of MaxCyte. "By working with MaxCyte, Wugen can maximize the number of doses in each manufacturing run for later stage clinical development and potential commercial phase."

"Our partnership with MaxCyte is an exciting step in advancing our groundbreaking therapies for difficult-to-treat cancers," said Kumar Srinivasan, PhD, MBA, President and CEO of Wugen. "This collaboration brings us even closer to delivering life-saving treatments to patients with limited options. With MaxCyte’s expertise, we’re in a position to expedite progress through crucial development stages and make a significant impact on patients’ lives."

MaxCyte’s ExPERT instrument portfolio represents the next generation of clinically validated electroporation technology for complex and scalable cell engineering. Offering high transfection efficiency, seamless scalability, and enhanced functionality, the ExPERT platform is crucial for enabling the next wave of biological and cellular therapeutics. Wugen is MaxCyte’s 26th clinical/commercial partnership overall, each of which generates pre-commercial milestone revenue, the vast majority of which includes sales-based payments.

On January 31, 2024 Immunocore Holdings plc (Nasdaq: IMCR) reported the pricing of $350.0 million aggregate principal amount of 2.50% convertible senior notes due 2030 (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"). Immunocore 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 $52.5 million aggregate principal amount of the notes (Press release, Immunocore, JAN 30, 2024, View Source [SID1234639745]). The sale of the notes is expected to close on February 2, 2024, subject to the satisfaction of customary closing conditions. The offering was upsized from the previously announced offering of $300.0 million aggregate principal amount of convertible senior notes.

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The notes will be senior, unsecured obligations of Immunocore and will accrue interest at a rate of 2.50% per annum, payable semi-annually in arrears on February 1 and August 1 of each year, beginning on August 1, 2024. The notes will mature on February 1, 2030, unless earlier converted, redeemed or repurchased.

Holders may convert all or any portion of their notes at their option at any time prior to the close of business on the business day immediately preceding the maturity date. Upon conversion, Immunocore will deliver for each $1,000 principal amount of converted notes a number of ordinary shares represented by American Depositary Shares (the "ADSs") (each currently representing one of Immunocore’s ordinary shares), equal to the conversion rate. The conversion rate will initially be 10.5601 ADSs per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $94.70 per ADS). The initial conversion price represents a premium of approximately 40.0% above the last reported sale price of $67.64 per ADS on the Nasdaq Global Select Market on January 30, 2024. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date or if Immunocore delivers a notice of optional redemption or a notice of tax redemption, Immunocore will, in certain circumstances, increase the conversion rate for a holder who elects to convert its notes in connection with such a corporate event or convert its notes called (or deemed called) for redemption in connection with such notice of optional redemption or notice of tax redemption, as the case may be.

Immunocore may not redeem the notes prior to February 5, 2027, except in the event of certain tax law changes as described in the indenture that will govern the notes. Immunocore may redeem for cash all or any portion of the notes (subject to certain limitations), at its option, on or after February 5, 2027 if the last reported sale price of ADSs has been at least 130% of the conversion price for the notes then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which Immunocore provides notice of optional redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the optional redemption date. No sinking fund is provided for the notes.

If Immunocore undergoes a "fundamental change" (as defined in the indenture that will govern the notes), then, subject to certain conditions and limited exceptions, holders may require Immunocore to repurchase for cash all or any portion of their notes at a fundamental change repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

Immunocore estimates that the net proceeds from the offering will be approximately $338.4 million (or approximately $389.3 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 payable by Immunocore. Immunocore intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to accelerate its clinical pipeline and for ongoing commercial expansion. In addition, Immunocore intends to repay in full loans outstanding under its loan agreement with investment funds managed by Pharmakon Advisors, LP. Immunocore intends to use any remaining proceeds for other working capital and general corporate purposes.

The offer and sale of the notes, the ADSs deliverable upon conversion of the notes and the ordinary shares represented thereby 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 deliverable upon conversion of the notes or the ordinary shares represented thereby, 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 January 30, 2024 CG Oncology, Inc. (Nasdaq: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer, reported the closing of its upsized initial public offering of 23,000,000 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase 3,000,000 additional shares, at an initial public offering price of $19.00 per share (Press release, CG Oncology, JAN 30, 2024, View Source [SID1234639730]). All of the shares were offered by CG Oncology. The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, were $437.0 million. CG Oncology’s common stock is listed on the Nasdaq Global Select Market under the ticker symbol "CGON."

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Morgan Stanley, Goldman Sachs & Co. LLC and Cantor acted as joint book-running managers for the offering. LifeSci Capital acted as co-manager for the offering.

Registration statements relating to the offering have been filed with the Securities and Exchange Commission (SEC) and became effective on January 24, 2024. A prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, 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 offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On January 30, 2024 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported a new study published in The Journal of Thoracic and Cardiovascular Surgery demonstrating the ability of Natera’s personalized and tumor-informed molecular residual disease (MRD) test, Signatera, to risk stratify and detect recurrence early in patients with resected stage I-II non-small cell lung cancer (NSCLC) (Press release, Natera, JAN 30, 2024, View Source [SID1234639729]). The full study can be found here.

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Worldwide, lung cancer is the second most commonly diagnosed cancer. In the U.S., NSCLC accounts for 81% of all lung cancer diagnoses.1 About 25-30% of NSCLC patients are diagnosed with stage I-II disease.2,3 These patients typically undergo curative-intent complete surgical resection and may be treated with adjuvant systemic therapy. However, 30–55% of patients develop disease recurrence within the first five years after surgery, and five-year overall survival ranges from 68-92% for stage I and 53-60% for stage II NSCLC patients respectively.4,5,6

Given the significant risk of recurrence and death in NSCLC, it is critical to accurately risk-stratify patients to identify who may derive benefit from additional treatment after surgery. In addition, there is a need for sensitive and specific biomarkers to support early detection of recurrence before the onset of disease-related symptoms at a time when therapy might provide greater clinical benefit.

This study investigated the association of circulating tumor DNA (ctDNA) status with recurrence-free survival (RFS), as well as changes in clinical practice after a positive ctDNA result in patients with resected stage I-II NSCLC. A total of 378 serial plasma samples from 108 NSCLC patients were analyzed after surgical resection, with a median clinical followup of 16 months.

Key findings include:

Patients who were ctDNA-positive within 6 months post-resection and prior to adjuvant treatment were 53-times more likely to recur (p<0.0001) as compared to ctDNA-negative patients.
ctDNA detection demonstrated a median lead time of 5.5 months when compared to confirmation of recurrence by radiographic imaging.
Post-operative surveillance strategies were altered in 100% of ctDNA-positive patients (earlier radiographic imaging), and patients with PET scans positive for malignant features received early referrals for treatment.
"This study demonstrates that serial monitoring with Signatera can identify patients who are most likely to benefit from adjuvant systemic therapy and/or more intensified imaging," said Minetta Liu, MD, chief medical officer of oncology at Natera. "With measurable clinical impact in 100% of Signatera MRD-positive cases, this study supports the utility of Signatera in the management of non-metastatic, resected NSCLC."

The study builds on previous Signatera data across early- and late-stage NSCLC. This includes a 2023 publication in Frontiers in Oncology, demonstrating Signatera’s ability to risk stratify and detect progression early in unresectable NSCLC,7 as well as the EMPower Lung-1 trial presented at the 2023 ASCO (Free ASCO Whitepaper) annual meeting, which showed Signatera’s ability to monitor response to immunotherapy and predict clinical outcomes in advanced NSCLC patients.8 This recent work also builds upon the 2017 TRACERx Nature publication that first reported Signatera’s ability to detect relapse early with high sensitivity and specificity in patients with resected NSCLC.9

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer (stage IIb and higher) and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 50 peer-reviewed papers.