On October 25, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that its CD19 oncolytic virotherapy drug candidate onCARlytics, has commenced a Phase 1 clinical trial, with the first patient now dosed (Press release, Imugene, OCT 25, 2023, View Source [SID1234636338]).

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The first-in-class Phase 1 clinical trial of onCARlytics (on-CAR-19, CF33-CD19 HOV4), known as OASIS, is being conducted in patients with solid tumours and is titled: "A Phase I, Dose Escalation and Dose Expansion, Safety and Tolerability Study of onCARlytics (CF33-CD19), Administered Intravenously or Intratumorally in Combination with Blinatumomab in Adults with Advanced or Metastatic Solid Tumors." See View Source

When combined with the CD19 targeting bispecific monoclonal antibody blinatumomab (Blincyto Amgen), onCARlytics has the potential to target and eradicate solid tumours that otherwise cannot be treated with Blincyto therapy alone. The clinical trial, for adult patients with advanced or metastatic solid tumours, aims to evaluate the safety and efficacy of two routes of administration, intratumoral (IT) injection and intravenous (IV) infusion, either alone, or in combination with blinatumomab.

The study is a dose escalation trial and is being conducted in the United States. The first patient with ovarian cancer has been dosed at City of Hope’s NCI-Designated Comprehensive Cancer Center in Duarte, California, USA.

Imugene Managing Director and CEO Leslie Chong said: "This is a milestone we’ve been eagerly anticipating, given the encouraging signs we have seen from the pre-clinical work performed to date. We believe onCARlytics may provide a new solution for clinicians treating solid tumours that have previously been untreatable using CD19-targeting biological drugs, and we hope our technology can bring much needed relief to patients in want of new treatments."

I am particularly pleased with the speed at which our team drove the pre-clinical data from a novel therapy, into a Phase 1 trial in a little over two years, and reflects the enthusiasm for this promising therapy, from all involved."

On October 25, 2023 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the third quarter ended September 30, 2023 (Press release, Thermo Fisher Scientific, OCT 25, 2023, View Source [SID1234636336]).

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Third Quarter 2023 Highlights

•Third quarter revenue was $10.57 billion, 1% lower versus the same quarter last year. Core organic revenue growth was 1%.
•Third quarter GAAP diluted earnings per share (EPS) was $4.42, 17% higher versus the same quarter last year, driven by 160 basis points of operating margin expansion.
•Third quarter adjusted EPS was $5.69, 12% higher versus the same quarter last year, driven by 200 basis points of adjusted operating margin expansion.

•The impact of the macroeconomic conditions that the industry has experienced through the year increased in the third quarter. Our PPI Business System and strong execution by our global team enabled the company to deliver strong financial performance for the quarter.

•Advanced our proven growth strategy, launching a range of high-impact, innovative new products, including the groundbreaking EXENT Solution in Europe, an offering from our protein diagnostics business, to help diagnose and monitor patients with blood protein abnormalities related to multiple myeloma and other disorders; the Gibco CTS Detachable Dynabeads, our next-generation platform of cell therapy reagents that enables process flexibility, scalability and higher drug efficacy for cell therapy manufacturers; and the Thermo Scientific Fill Finish Solution, to improve the efficiency of the sterile fill-finish process, a great example of innovation for drug manufacturing.

•Shortly after the quarter ended, announced an agreement to acquire Olink Holding AB (publ) ("Olink") (Nasdaq: OLK) for a net purchase price of approximately $3.1 billion. Olink is a provider of differentiated next-generation proteomic solutions that enable our customers to meaningfully accelerate discovery and scientific breakthroughs and is highly complementary to our leading mass spectrometry and life sciences offerings.

•Building on our environmental, social and governance (ESG) priorities, we are collaborating with the National Minority Quality Forum (NMQF) to make clinical research more accessible to historically underserved communities. The collaboration supports biopharmaceutical and biotech customers’ desire to increase diversity in clinical trials by enrolling and retaining patients who more fully reflect real-world populations.

"While market conditions further weakened during the third quarter, I’m very pleased with our team’s execution which enabled our company to deliver both excellent margin expansion and adjusted EPS growth," said Marc Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "Our experienced management team is leveraging our PPI Business System to effectively manage through the current dynamic environment. We also continue to invest for the future and a great example of this is our recently announced agreement to acquire Olink."

Casper added, "We are incredibly focused on delivering differentiated short-term performance while enhancing our long-term competitive position."

Third Quarter 2023

Revenue for the quarter declined 1% to $10.57 billion in 2023, versus $10.68 billion in 2022. Organic revenue was 3% lower, Core organic revenue growth was 1%, and COVID-19 testing revenue was $0.05 billion.

GAAP Earnings Results

GAAP diluted EPS in the third quarter of 2023 was $4.42, versus $3.79 in the same quarter last year. GAAP operating income for the third quarter of 2023 was $1.86 billion, compared with $1.71 billion in the year-ago quarter. GAAP operating margin was 17.6%, compared with 16.0% in the third quarter of 2022.

Non-GAAP Earnings Results

Adjusted EPS in the third quarter of 2023 was $5.69, versus $5.08 in the third quarter of 2022. Adjusted operating income for the third quarter of 2023 was $2.56 billion, compared with $2.37 billion in the year-ago quarter. Adjusted operating margin was 24.2%, compared with 22.2% in the third quarter of 2022.

Annual Guidance for 2023

Given the current macroeconomic environment, Thermo Fisher is revising revenue and adjusted EPS guidance for the full year. The company now expects 2023 revenue to be $42.7 billion, with Core organic revenue growth of 1%, and adjusted EPS of $21.50.

Use of Non-GAAP Financial Measures

Adjusted EPS, adjusted net income, adjusted operating income, adjusted operating margin, free cash flow, organic revenue growth and Core organic revenue growth are non-GAAP measures that exclude certain items detailed after the tables that accompany this press release, under the heading "Supplemental Information Regarding Non-GAAP Financial Measures." The reconciliations of GAAP to non-GAAP financial measures are provided in the tables that accompany this press release.

Conference Call

During the call, the company will discuss its financial performance, as well as future expectations. To listen, call (833) 470-1428 within the U.S. or (404) 975-4839 outside the U.S. The access code is 385381. You may also listen to the call live on the "Investors" section of our website, www.thermofisher.com. The earnings press release and related information can also be found in that section of our website under the heading "Financials". A replay of the call will be available under "News, Events & Presentations" through Friday, November 10, 2023.

On October 25, 2023 Theratechnologies Inc. ("Theratechnologies" or the "Company") (Nasdaq: THTX; TSX: TH), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported the launch of a marketed public offering (the "Public Offering") of common shares of the Company (the "Common Shares") (Press release, Theratechnologies, OCT 25, 2023, View Source [SID1234636335]). The Company intends to grant the underwriter a 30-day option to purchase up to an additional 15% of the number of Common Shares to be sold pursuant to the Public Offering (the "Option").

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In connection with the Public Offering, the Company intends to enter into a subscription agreement with Investissement Québec for a concurrent private placement of Common Shares (and Common Share equivalents in the form of pre-funded, non-voting subscription receipts, exchangeable into Common Shares on a one-for-one basis (the "Exchangeable Subscription Receipts") in lieu of Common Shares), for up to US$12.5 million aggregate gross proceeds (the "Concurrent Private Placement"). As part of the Concurrent Private Placement, it is expected that Investissement Québec will be granted rights to nominate one director to the Company’s board of directors. The consummation of the Concurrent Private Placement will be contingent upon the closing of the Public Offering.

Cantor Fitzgerald & Co. is acting as the underwriter for the Public Offering.

A preliminary prospectus supplement (the "Prospectus Supplement") to the Company’s short form base shelf prospectus dated December 14, 2021 (the "Base Shelf Prospectus") was filed with the securities regulatory authorities in each of the provinces of Canada as well as with the U.S. Securities and Exchange Commission (the "SEC") as part of its registration statement on Form F-10 (the "Registration Statement") under the U.S.-Canada multijurisdictional disclosure system ("MJDS"). The Public Offering will be made in Canada only pursuant to the Prospectus Supplement and Base Shelf Prospectus and in the United States only pursuant to the Registration Statement, containing the Prospectus Supplement and the Base Shelf Prospectus, filed with the SEC under the MJDS. Copies of the Prospectus Supplement and the Base Shelf Prospectus are available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov, and a copy of the Registration Statement is available on EDGAR at www.sec.gov. Copies may also be obtained from Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by e-mail at [email protected].

Completion of the Public Offering and Concurrent Private Placement will be subject to customary closing conditions, including the listing of the Common Shares and the Common Shares underlying the Exchangeable Subscription Receipts on the Toronto Stock Exchange and the submission of notice to the Nasdaq Global Market.

Prospective investors should read the Prospectus Supplement, Base Shelf Prospectus and Registration Statement before making an investment decision.

No securities regulatory authority has either approved or disapproved the contents of this news release. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, 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 province, state or jurisdiction.

On October 25, 2023 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company expects to report financial and business results for the third quarter of 2023 after the market closes on Wednesday, November 8, 2023 (Press release, Supernus, OCT 25, 2023, View Source [SID1234636334]).

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Jack Khattar, President and CEO, and Tim Dec, Senior Vice President and CFO, will host a conference call to present the third quarter 2023 financial and business results on Wednesday, November 8, 2023, at 4:30 p.m. ET. Following management’s prepared remarks and discussion of business results, the call will be open for questions.

A live webcast will be accessible in the Events & Presentations section of the Company’s Investor Relations website at www.supernus.com/investors.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s Investor Relations website at www.supernus.com/investors. The webcast will be available on the Company’s website for 60 days following the live call.

On October 25, 2023 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("we," "us," "our," "Sonnet" or the "Company"), a clinical-stage company developing innovative targeted biologic drugs, reported the pricing of an underwritten public offering of 2,843,750 shares of common stock (or pre-funded warrants to purchase shares of common stock in lieu of shares of common stock) and investor warrants to purchase up to an aggregate of 5,687,500 shares of common stock (Press release, Sonnet BioTherapeutics, OCT 25, 2023, View Source [SID1234636333]). Each share of common stock (or pre-funded warrant in lieu thereof) is being sold together with two investor warrants at a combined offering price of $1.60, for total gross proceeds of approximately $4.55 million, before underwriting discounts and commissions and offering expenses payable by Sonnet. Each investor warrant is exercisable for one share of common stock at an exercise price of $1.60 per share for a period of five years from the date of issuance. The offering is expected to close on or about October 27, 2023, subject to the satisfaction or waiver of customary closing conditions. The offering is being led by existing investors.

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Chardan and Ladenburg Thalmann & Co. Inc. are acting as joint book-running managers in connection with the offering.

Sonnet anticipates using the net proceeds from the offering for research and development, including clinical trials, working capital and general corporate purposes.

The securities will be offered pursuant to a registration statement on Form S-1, as amended (File No. 333-274581), which was declared effective by the Securities and Exchange Commission (the "SEC") on October 24, 2023. The offering is being made solely by means of a prospectus. A preliminary 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. Copies of the preliminary prospectus and, when available, copies of the final prospectus relating to this offering can be obtained at the SEC’s website at www.sec.gov or from Chardan Capital Markets, LLC, 17 State Street, Suite 2130, New York, New York 10004, at (646) 465-9000, or by email at [email protected] or by contacting Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at [email protected].

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