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FORM 8-K

On November 14, 2022, at the request of the FDA, Clovis Oncology, Inc. (the "Company") met by teleconference with the FDA to discuss the overall survival (OS) data from the Company’s ARIEL3 clinical trial (Filing, Clovis Oncology, NOV 14, 2022, View Source [SID1234624529]). The ARIEL3 dataset formed the basis for the approval of Rubraca in the US in April 2018 and in Europe in January 2019 respectively, as second-line maintenance treatment in adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The Company submitted final OS data, including in exploratory subgroups, from the ARIEL3 study to the FDA in September 2022. The FDA requested that the Company voluntarily revise the label to limit the indication of Rubraca in this second-line maintenance treatment to tBRCA patients only. The FDA further indicated to the Company that if an agreement could not be reached on the revised indication, the FDA would convene an ODAC meeting to review this matter. The Company is currently evaluating FDA’s request.

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10-Q – Quarterly report [Sections 13 or 15(d)]

CASI Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

Lupeng Pharmaceutical completed the second round of pre-B financing of US$35 million, and is committed to the key registration clinical research of the company’s core projects

On November 14, 2022 Lupeng Pharmaceutical Ltd. ("Lupeng Pharmaceutical") reported that successfully completed the second phase of the Pre-B round of financing totaling US$35 million (Press release, Guangzhou Lupeng Pharmaceutical, NOV 14, 2022, View Source [SID1234624136]).

The second phase of the Pre-B round of financing was led by world-renowned investment institutions Kaitai Capital and Temasek, followed by other strategic investors such as Lilly Asia Ventures (LAV), Fengchuan Capital, and Qingchi Capital.

The funds raised in this round of financing will be used for the clinical research of the industry-leading product LP-168, the highly selective Bcl-2 inhibitor LP-108, and LP-118.

Dr. Tan Fenlai and Dr. Chen Yi, co-founders of the company, said: "Under the influence of the current market environment and the macro environment, investors are more pursuing certainty and stability. In our core projects LP-168 and LP-108 We are about to enter the stage of critical registration clinical research for listing, and we are honored to receive further financial support from well-known investment institutions and recognition in terms of technical level and value potential. This financing is another milestone for Lupeng Pharmaceuticals. An important milestone, after this financing, the company will focus its resources on the clinical registration research of core projects, accelerate the research process of core products, and bring good medicines to cancer patients around the world as soon as possible."

Mr. Li Xianxian, partner of Kaitai Capital, said: "Congratulations to Lupeng for completing the new round of financing. As the company’s seed round investor, Kaitai Capital has witnessed the rapid and high-quality development of Lupeng Pharmaceuticals. During this process, the Lupeng team Demonstrating excellent innovation and execution capabilities, Kaitai has also participated in the company’s subsequent rounds of financing for many times. The completion of this financing symbolizes that the company has entered a new stage closer to industrialization and capitalization. We Continue to participate in this round of financing, hope to continue to support Lupeng’s new drug development business, and wish Lupeng greater achievements in the new stage!"

Acrivon Therapeutics Announces Pricing of Initial Public Offering

On November 14, 2022 Acrivon Therapeutics, Inc. ("Acrivon" or "Acrivon Therapeutics") (Nasdaq: ACRV), a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing its proprietary proteomics-based patient responder identification platform, reported the pricing of its initial public offering of 7,550,000 shares of common stock at a public offering price of $12.50 per share (Press release, Acrivon Therapeutics, NOV 14, 2022, View Source [SID1234624135]). In addition, Acrivon has granted the underwriters a 30-day option to purchase up to an additional 1,132,500 shares of common stock at the initial public offering price, less underwriting discounts and commissions. In addition to the shares sold in the initial public offering, Acrivon announced a concurrent sale of 400,000 shares of common stock at the public offering price per share in a private placement to Chione Limited, an existing stockholder of Acrivon. The sale of the shares of common stock in the private placement will not be registered under the Securities Act of 1933, as amended. The gross proceeds to Acrivon from the initial public offering and the concurrent private placement, without giving effect to the underwriters’ option to purchase additional shares and before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $99.4 million. All of the shares of common stock are being offered by Acrivon.

Acrivon’s shares are expected to begin trading on the Nasdaq Global Market on November 15, 2022 under the ticker symbol "ACRV." The offering is expected to close on November 17, 2022, subject to customary closing conditions.

Jefferies, Cowen and Piper Sandler are acting as joint lead book-running managers for the offering.

A registration statement relating to the shares being sold in this offering has been filed with the U.S. Securities and Exchange Commission and was declared effective on November 9, 2022. The offering of the shares is being made only by means of a prospectus forming part of the effective registration statement relating to these shares. Copies of the final prospectus, when available, may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022 or by emailing [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attention: Prospectus Department, email: [email protected], telephone: 1-833-297-2926; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at [email protected].

The concurrent private placement is also scheduled to close on November 17, 2022, subject to the satisfaction of customary closing conditions. The closing of Acrivon’s initial public offering is not conditioned upon the closing of the concurrent private placement, but the closing of the concurrent private placement is conditioned upon the closing of the initial public offering.

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.

Cue Biopharma Reports Third Quarter 2022 Financial Results

On November 14, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate tumor-specific T cells directly within the patient’s body, reported third quarter 2022 financial results (Press release, Cue Biopharma, NOV 14, 2022, View Source [SID1234624104]). The Company will host a business update call in conjunction with its financial results press release on November 14, 2022.

Recent Business Updates

Announced a $30 million private investment in public equity (PIPE) financing with certain accredited investors in which the company agreed to sell 7,656,966 shares of its common stock and, in lieu of shares of common stock to certain investors, pre-funded warrants to purchase an aggregate of 1,531,440 shares of common stock, and, in each case, accompanying warrants to purchase an aggregate of up to 9,188,406 additional shares of common stock (or Pre-Funded Warrants). The transaction is expected to close on or about November 16, 2022, subject to the satisfaction of customary closing conditions.
Presented new positive data from the ongoing Phase 1 trials of CUE-101 in combination with pembrolizumab (KEYTRUDA) and as a monotherapy for recurrent/metastatic HPV+ head and neck squamous cell carcinoma (r/m HNSCC) at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting on November 10, 2022.

Key data highlights from the dose escalation and patient expansion portion of the Phase 1 trial evaluating CUE-101 at the recommended Phase 2 dose in combination with pembrolizumab include a 40% overall response rate (ORR) and a 70% clinical benefit rate (CBR) in first line (1L) r/m HNSCC patients treated with CUE-101, with 16 evaluable patients to date.

Median overall survival (mOS) approaching greater than 12 months in third line and beyond (3L+) patients treated with CUE-101 monotherapy, which is 50% greater than current standard of care (SOC) with anti-PD-1 therapy in second line (2L) patients.
"With our anticipated strengthened financial position and with bolstered confidence from the recently reported clinical update at SITC (Free SITC Whitepaper), we are able to focus on core strategic initiatives to further enhance our competitive positioning to optimize shareholder value," said Daniel Passeri, chief executive officer of Cue Biopharma.

Kerri-Ann Millar, chief financial officer of Cue Biopharma, added, "We are pleased to have announced our private placement, which would extend our cash runway into 2024 upon closing and further strengthen our ability to assess the CUE-101 data readouts from both the Phase 1 monotherapy and combination clinical trials and remain on track to define a potential registrational CUE-101 monotherapy trial by mid-2023."

Third-Quarter 2022 Financial Results
The Company reported collaboration revenue of approximately $68 thousand and $2.4 million for the three months ended September 30, 2022 and 2021, respectively.

Research and development expenses were $7.6 million and $11.3 million for the three months ended September 30, 2022 and 2021, respectively. The decrease in research and development expenses of $3.7 million was primarily due to a decrease in laboratory and drug substance manufacturing costs, employee and Scientific and Clinical Advisory Board compensation, other professional fees, licensing fees, and rent.

General and administrative expenses were $3.5 million and $4.1 million for the three months ended September 30, 2022 and 2021, respectively. The decrease in general and administrative expense of $0.6 million was primarily due to a decrease in stock-based compensation expense related to executive management, professional and consulting fees, and employee and board compensation incurred in the third quarter of 2022 as compared to the same period in 2021.