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Theratechnologies Announces Closing of US$25 Million Public Offering of Common Shares and Concurrent Private Placement

On October 31, 2023 Theratechnologies Inc. ("Theratechnologies" or the "Company") (Nasdaq: THTX; TSX: TH), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has closed its previously announced public offering (the "Public Offering") of 12,500,000 common shares of the Company (the "Common Shares") at a public offering price of US$1.00 per Common Share (the "Offering Price") (Press release, Theratechnologies, OCT 31, 2023, View Source [SID1234636555]). The gross proceeds of the Public Offering are US$12,500,000, before deducting the underwriting discounts and commissions and other estimated offering expenses. Pursuant to the underwriting agreement dated October 25, 2023, the Company has also granted the underwriter a 30-day option (the "Option") to purchase up to 1,875,000 Common Shares at the Offering Price, less underwriting discounts and commissions.

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Cantor Fitzgerald & Co. acted as sole bookrunner for the Public Offering.

In connection with the Public Offering, the Company has also closed its concurrent private placement with Investissement Québec (the "Concurrent Private Placement") of 9,118,184 Common Shares and 3,381,816 fully-funded, non-voting subscription receipts, exchangeable into Common Shares on a one-for-one basis (the "Exchangeable Subscription Receipts") in lieu of Common Shares, in each case, at the Offering Price, for US$12,500,000 aggregate gross proceeds, less a capital commitment fee of 1.5% payable to Investissement Québec and Investissement Québec’s legal fees. The component of the Concurrent Private Placement in the form of Exchangeable Subscription Receipts is designed to ensure that, following completion of the Public Offering and the Concurrent Private Placement, Investissement Québec does not have beneficial ownership or control over more than 19.9% of the issued and outstanding Common Shares and therefore is not a "control person" within applicable Canadian securities laws. All securities issued in connection with the Concurrent Private Placement are subject to a four-month hold period from the closing date under applicable Canadian securities laws, in addition to such other restrictions as may apply under applicable securities laws of jurisdictions outside Canada.

The Company also entered into an investor rights agreement, pursuant to which Investissement Québec will be entitled to nominate one director to the Company’s board of directors for as long as it holds 50% of the Common Shares purchased pursuant to the Concurrent Private Placement. Copies of the subscription agreement, the exchangeable receipt agreement setting forth the terms and conditions of the Exchangeable Subscription Receipts and the investor rights agreement, when available, will be filed on SEDAR+ at www.sedarplus.ca. Summaries of the subscription agreement and the exchangeable receipt agreement and a copy of the investor rights agreement, when available, will be filed on EDGAR at www.sec.gov.

As at the date of closing, Investissement Québec beneficially owns approximately 19.9% (25.4% if the Exchangeable Subscription Receipts were to be exchanged into Common Shares) of the issued and outstanding Common Shares. If the Option is exercised in full, Investissement Québec will beneficially own approximately 19.1% (24.5% if the Exchangeable Subscription Receipts were to be exchanged into Common Shares) of the issued and outstanding Common Shares as of the date of closing.

The Public Offering and the Concurrent Private Placement are subject to final acceptance of the Toronto Stock Exchange.

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.

Sonnet BioTherapeutics Provides Fiscal Year 2023 Business Overview

On October 31, 2023 Sonnet BioTherapeutics Holdings, Inc., (NASDAQ:SONN) a clinical-stage company developing targeted immunotherapeutic drugs for cancer, reported a fiscal year 2023 business overview (Press release, Sonnet BioTherapeutics, OCT 31, 2023, View Source [SID1234636554]).

"As has been our objective since the company’s founding, we are committed to innovating next generation cancer treatments of significant potential utility for patients and caregivers, alike," commented Pankaj Mohan, Ph.D., Founder and CEO of Sonnet. "I am excited by the progress of our therapeutic pipeline, and we remain acutely focused on our business development initiatives. We continue to believe this represents a compelling value proposition for investors in the company."

Overview of Corporate Developments

In October, Sonnet completed an underwritten public offering led by existing investors for total gross proceeds of approximately $4.55 million. The company anticipates using the net proceeds from the offering for research and development, including clinical trials, working capital and general corporate purposes. After undertaking significant cost reductions designed to fund assets with the highest estimated business development potential, cash runway is projected into the calendar year third quarter of 2024.
In August, the FDA accepted Sonnet’s IND for the SB221, the Phase 1b/2a US clinical trial of SON-1010 (IL12-FHAB) in combination with Roche’s anti-PD-L1 checkpoint inhibitor, atezolizumab. The study has been launched with several patients currently being dosed. The trial consists of a modified 3+3 dose-escalation design in Part 1 to establish the maximum tolerated dose (MTD) of SON-1010 with a fixed dose of atezolizumab. Clinical benefit in PROC will be confirmed in an expansion group to establish the recommended Phase 2 dose. Part 2 of the study will then investigate SON-1010 monotherapy, its use in combination with atezolizumab, or the standard of care (SOC) for PROC in a randomized comparison to show proof-of-concept (POC).
Sonnet is working to complete enrollment in the SON-080 trial in chemotherapy-induced peripheral neuropathy (CIPN) and continues to expect early safety data prior to the 2023 calendar year end.
The evaluation of SON-1010, SON-1210 and SON-1410 in combination with certain of Janssen’s proprietary cell therapy assets remains underway.

Shorla Oncology Announces US Acquisition of Jylamvo, an Oncology and Autoimmune Drug from Therakind

On October 31, 2023 Shorla Oncology (‘Shorla’), a US-Ireland specialty pharmaceutical company, and Therakind Ltd (‘Therakind’), a UK-based specialty pharmaceutical company reported to have have entered into an agreement under which Shorla has agreed to acquire Jylamvo, an oncology and autoimmune drug, for the US market (Press release, Shorla Oncology, OCT 31, 2023, View Source;utm_medium=rss&utm_campaign=press-release-shorla-oncology-announces-us-acquisition-of-jylamvo-an-oncology-and-autoimmune-drug-from-therakind [SID1234636553]). The therapy has been approved by the US Food and Drug Administration (FDA).

Jylamvo is an easy-to-administer, sweet tasting oral methotrexate solution that eliminates the need for crushing or splitting pills, or compounding into a liquid formulation. A drug that has recently suffered shortages in other dosages forms, Jylamvo is an alternative solution offering advantages over similar drugs because it remains stable at room temperature and does not require cold chain storage. It was approved by the US FDA in 2022 and is used to treat adults with acute lymphoblastic leukemia, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis and severe psoriasis.

"We are delighted to acquire Jylamvo to provide an alternative solution for patients who may have difficulty swallowing pills," said Sharon Cunningham, chief executive officer of Shorla Oncology. "This is another key step as Shorla grows and commercializes a portfolio of late-stage assets and improves efficiencies by providing more convenient and patient friendly formulations."

The news comes shortly after Shorla announced that it has raised $35 million in Series B funding to accelerate the growth of its oncology portfolio by bringing therapies to market that will address drug shortages, and improve the preparation and application of oncology medication. This marks Shorla’s second US FDA approved product in its oncology portfolio.

"Therakind is pleased that Jylamvo will now become available to patients in the United States providing a palatable oral liquid alternative to treat a range of indications," said Susan Conroy, chief executive officer of Therakind.

"This acquisition will provide a much-needed treatment to patients in need," said Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology. "It brings a crucial oral treatment to a larger patient population who suffer from cancer and other debilitating illnesses."

SELLAS Life Sciences Announces $4 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

On October 31, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that it has entered into a securities purchase agreement with a single, healthcare-focused U.S. institutional investor for the purchase and sale of 3,652,300 shares of common stock (or common stock equivalents in lieu thereof) at a purchase price of $1.0952 per share, priced at-the-market under Nasdaq rules pursuant to a registered direct offering resulting in total gross proceeds of approximately $4 million, before deducting placement agent commissions and other estimated offering expenses (Press release, Sellas Life Sciences, OCT 31, 2023, View Source [SID1234636552]). The Company further agreed to issue to the investor warrants to purchase up to an aggregate of 3,652,300 shares of common stock. The warrants will have an exercise price of $0.9702, will be immediately exercisable and will expire five years after issuance. The closing of the offering is expected to occur on or about November 2, 2023, subject to the satisfaction of customary closing conditions.

A.G.P./Alliance Global Partners is acting as the lead placement agent for the offering and Maxim Group LLC is acting as a co-placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No 333-255318) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, 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 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.

PharmaMar initiates a Phase IIb/III clinical trial of Zepzelca® (lurbinectedin) for the treatment of patients with metastatic Leiomyosarcoma

On October 31, 2023 PharmaMar (MSE:PHM) reported the initiation of a Phase IIb/III clinical trial (SaLuDo, Sarcoma patients treated with Lurbinectedin and Doxorubicin)) with lurbinectedin in combination with doxorubicin for the first-line treatment of patients with metastatic Leiomyosarcoma (LMS) (Press release, PharmaMar, OCT 31, 2023, View Source [SID1234636551]). The trial will evaluate Progression-Free Survival (PFS) as the primary endpoint and Overall Survival (OS) as one of the secondary endpoints of treatment with the combination of lurbinectedin and doxorubicin compared to the current standard of care in Leiomyosarcoma, which is doxorubicin.

This clinical trial consists of 2 phases. Phase IIb includes three treatment arms: two arms will evaluate the combination of lurbinectedin plus doxorubicin at different doses, and the control arm will evaluate single-agent doxorubicin. At the end of this phase, the best combination scheme of the lurbinectedin plus doxorubicin combination will be chosen to continue with phase III in which the chosen combination scheme will be compared with doxorubicin administered as a single agent.

The trial will be conducted in patients with metastatic LMS as a first line of treatment. Leiomyosarcoma is a subtype of Soft Tissue Sarcoma (STS) that accounts for 10-20% of all cases. Due to the low frequency of STS (1% of all cancers seen in adult population), Leiomyosarcoma is categorized as a "rare tumor". Leiomyosarcoma originates in smooth muscles. The body contains smooth muscle tissue in hollow organs (intestines, stomach or bladder), as well as in blood vessels (including the extremities) and in women, there are also smooth muscles in the uterus.

The SaLuDo trial involves 76 centers in the United States and several European countries, including Spain.

"We are initiating this trial for the treatment of a pathology that today has few therapeutic alternatives for patients despite representing one of the most common sarcoma subtypes. With the promising results presented recently at ASCO (Free ASCO Whitepaper) this year from a phase Ib presented by Dr Gregory Cote, lurbinectedin in combination with doxorubicin would be a better option for patients with this pathology in first line treatment if the trial confirms the endpoint," commented Dr. Ali Zeaiter, VP and Head of Clinical Development at PharmarMar.