On January 18, 2024 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported that the US FDA have cleared Amplia’s IND application for a trial of Amplia’s best-in-class focal adhesion kinase (FAK) inhibitor narmafotinib in pancreatic cancer (Press release, Amplia Therapeutics, JAN 18, 2024, View Source [SID1234639295]). The proposed trial will explore the safety, tolerability and efficacy of a combination of narmafotinib with the chemotherapy regime FOLFIRINOX.

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The company is currently undertaking a Phase 2a clinical trial of narmafotinib, in combination with two chemotherapy drugs, gemcitabine and Abraxane, in advanced pancreatic patients in Australia and South Korea. In contrast, the IND application reviewed by the US Food and Drug Administration (FDA) supports the use of narmafotinib in combination with a different chemotherapy called FOLFIRINOX (a four drug regimen), which is widely employed in the US for the treatment of pancreatic cancer.

The IND document is an extensive dossier that details all preclinical and clinical data amassed to date for narmafotinib, along with complete CMC (chemistry, manufacturing and controls) information. The final document comprised more than 10,000 pages and represented a major undertaking by the company over the previous months.

Amplia CEO and MD Dr Chris Burns commented: "Clearance of the IND by the US FDA is a significant step forward for the Company. We will now start planning the combination trial of narmafotinib with FOLFIRINOX in the US, which expands the clinical opportunities for our best-in-class FAK inhibitor. FOLFIRINOX is the preferred treatment for pancreatic patients in the USA and most of Europe, and therefore this combination trial is highly relevant as we position narmafotinib as the preferred drug to enhance the effectiveness of existing chemotherapy combinations in pancreatic cancer."

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On January 17, 2024, Alector, Inc. (the "Company") entered into an underwriting agreement (the "Underwriting Agreement") with Cantor Fitzgerald & Co. (the "Underwriter"), relating to the issuance and sale (the "Offering") of 10,869,566 shares of the Company’s common stock, par value $0.0001 per share, at a price per share of $6.57 to be paid by the Underwriter (the "Underwritten Shares") (Filing, Alector, JAN 17, 2024, View Source [SID1234640081]). The Company also granted the Underwriter an option exercisable for 30 days from the date of the Underwriting Agreement to purchase up to an additional 1,630,434 shares of common stock (together with the Underwritten Shares, the "Shares"). All of the Shares in the Offering are being sold by the Company.

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The gross proceeds from the Offering are expected to be approximately $75 million before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company and assuming no exercise of the Underwriter’s option to purchase additional shares. The Offering is expected to close on January 19, 2024, subject to the satisfaction of customary closing conditions.

The Underwriting Agreement contains customary representations, warranties, and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriter, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties, and termination provisions. The representations, warranties, and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by such parties.

The Offering is being made pursuant to the Company’s effective registration statement on Form S-3 (File No. 333-270126) (the "Registration Statement"), which was declared effective by the Securities and Exchange Commission (the "Commission") on May 1, 2023, and a related prospectus and prospectus supplement, each as filed with the Commission.

The above summary of the Underwriting Agreement does not purport to be complete and is qualified in its entirety by reference to the Underwriting Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. The legal opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation relating to the shares of common stock being offered pursuant to the Underwriting Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K.

On January 17, 2024 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported the pricing of an underwritten public offering of 15,925,000 ordinary shares at a public offering price of $11.00 per share (Press release, Immatics, JAN 17, 2024, View Source [SID1234639331]). The gross proceeds from the offering, before deducting the underwriting discount and offering expenses, are expected to be approximately $175 million. The offering is expected to close on January 22, 2024, subject to customary closing conditions. In addition, Immatics has granted the underwriters a 30-day option to purchase up to 2,388,750 additional shares at the public offering price, less the underwriting discount.

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Jefferies, BofA Securities and Leerink Partners are acting as joint book-running managers for the offering.

A registration statement relating to the securities has been filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on August 9, 2021. The offering is being made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained free of charge from

Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, telephone: (877) 821-7388, email: [email protected];
BofA Securities, Attention: Prospectus Department, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, telephone: (800) 294-1322, email: [email protected];
Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, telephone: (800) 808-7525, ext. 6105, email: [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. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

On January 17, 2024 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported the pricing of an underwritten public offering of 10,869,566 shares of its common stock for total gross proceeds of $75 million before deducting underwriting discounts and commissions and estimated offering expenses payable by Alector (Press release, Alector, JAN 17, 2024, View Source [SID1234639322]). The offering is expected to close on January 19, 2024, subject to satisfaction of customary closing conditions. All of the shares in the offering are being sold by Alector.

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Alector has granted the underwriter a 30-day option to purchase up to an additional 1,630,434 shares of its common stock offered in the public offering, at the public offering price, less underwriting discounts and commissions.

Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333- 270126) that was previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC") on May 1, 2023. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website at View Source A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, 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 January 17, 2024 Cleveland Diagnostics, Inc., a clinical-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers reported the closing of over $75M in growth capital financing (Press release, Cleveland Diagnostics, JAN 17, 2024, View Source [SID1234639303]). The financing was led by Novo Holdings, a leading global life sciences investor, responsible for managing the assets of the Novo Nordisk Foundation, along with participation from existing investors as well as a credit facility from Symbiotic Capital. The financing will accelerate Cleveland Diagnostics’ commercial and corporate development goals.

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"We are pleased to have secured this growth capital and support from a mix of new and existing investors, exhibiting their confidence in our company’s growth potential and our ability to execute financial discipline as we anticipate increased test utilization and achievements of key clinical and regulatory milestones in 2024," said Arnon Chait, Ph.D., Cleveland Diagnostics CEO & co-founder. "These funds provide Cleveland Diagnostics the capital and flexibility to advance our portfolio of non-invasive tests as demonstrated by the rapidly increasing demand for our IsoPSA prostate cancer test."

IsoPSA is a blood test used to further stratify the risk of prostate cancer and aid in biopsy decisions for men identified at higher risk based on results from screening methods, such as PSA testing. Differentiating cancer from benign conditions, this protein-based test is critical for many patients to identify cancer at its earliest stage to minimize the cost of overdiagnosis and overtreatment – a vital test as 1 in every 8 men are expected to be diagnosed with prostate cancer in their lifetime. In 2023 alone, there were an estimated 288,000 new prostate cancer diagnoses and over 34,000 deaths in the United States, according to the American Cancer Society. IsoPSA can provide more specific insights to better inform healthcare providers and support actionable evidence when evaluating the ongoing unmet medical need for patients affected by prostate cancer.

Cleveland Diagnostics’ portfolio of oncology related tests will be expanding beyond prostate cancer into additional indications in 2024. Proceeds will accelerate the commercial strategy of IsoPSA, fund expanded infrastructure and R&D pipeline development, and broaden the geographic scope of its novel IsoPSA prostate cancer test.

"It’s all about the patients," said Noel Jee, Partner on the Growth Investments team at Novo Holdings US. "We believe that IsoPSA has the potential to improve treatment, reduce costs, and increase quality-of-life for patients who may have prostate cancer. The company’s differentiated blood-based approach presents an opportunity to further improve diagnostics for other cancers and diseases."

In connection with the financing, Jee will join the Cleveland Diagnostics Board of Directors.

"We are delighted to be a part of ClevelandDx’s growth trajectory and support the team as they tackle the diagnostic uncertainty that remains in urology and other therapeutic areas," added Jee.