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.

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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.

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.

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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.

On November 14, 2022 Chemomab Therapeutics, Ltd. (Nasdaq: CMMB) (Chemomab), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported the appointment of Matthew Frankel, MD, MBA as Chief Medical Officer (CMO) and Vice President of Drug Development (Press release, Anchiano Therapeutics, NOV 14, 2022, View Source [SID1234624085]).

"We believe Dr. Frankel’s wealth of experience across all aspects of clinical development and medical affairs, along with his outstanding performance in helping to bring biologic and small molecule drugs to market for both rare and chronic diseases, will be invaluable as we advance the CM-101 clinical program," said Dale Pfost, PhD, Chief Executive Officer of Chemomab. "We have greatly benefitted from the singular talents of interim CMO Dave Weiner, who will be staying on as a Senior Advisor, and are fortunate now to have Matt Frankel, with his exceptional breadth of experience and track record of success, joining as our full- time CMO."

Dr. Frankel most recently served as Vice President, Clinical Development and Medical Affairs, Specialty Pharma at Boehringer Ingelheim, where he led functional teams developing new drugs for oncology, immunology, pulmonary, and central nervous system diseases. Previously Dr. Frankel was Vice President & Head, Immunology and Dermatology Medical Unit at Novartis, where he oversaw medical affairs activities and late phase clinical development for Cosentyx, Ilaris, and Zortress. At the Sandoz unit of Novartis, Dr. Frankel successfully built and led the medical affairs organization supporting the biopharmaceutical, biosimilar and generics businesses for launches including Kerydin, Glatopa and Zarxio.

"Chemomab’s CM-101 is an intriguing investigational drug, with its novel CCL24 target, dual mechanism of action, breadth of application and disease-modifying potential in serious progressive diseases with few effective treatment options," said Dr. Frankel. "Chemomab scientists have assembled an impressive body of preclinical and early clinical evidence supporting the utility of their approach, and I welcome the opportunity to join this talented team as we move to rapidly expand and accelerate our CM-101 clinical programs."

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Earlier in his career, Dr. Frankel held clinical development leadership roles across geographies and therapeutic disease areas at Reata, Fibrogen, Abbott Labs, and Schering Plough. Dr. Frankel received a BA degree from Vassar College, an MD degree from the University of California School of Medicine, Los Angeles and an MBA from the J. L. Kellogg Graduate School of Management at Northwestern University.

He is board certified in internal medicine.

On November 14, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported business highlights and financial results for the third quarter ended September 30, 2022 (Press release, Arcellx, NOV 14, 2022, View Source [SID1234624084]).

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"Helping patients is at the core of everything we do at Arcellx," said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. "To that end, we made significant progress advancing our lead program, CART-ddBCMA for the treatment of relapsed or refractory multiple myeloma with the initiation of our iMMagine-1 pivotal study. Following the submission of IND amendments for the technical transfer of our cell and vector manufacturing, we have begun to operationally scale by initiating clinical sites, enrolling patients and dosing our first patients from Lonza, our pivotal cell manufacturer. We are currently manufacturing cells with Oxford vector at Lonza and plan to dose patients with our pivotal drug product by the end of the year. Additionally, we look forward to presenting longer-term patient data from our Phase 1 CART-ddBCMA expansion trial at the 64th ASH (Free ASH Whitepaper) Annual Meeting. We continue to plan to initiate our Phase 1 ARC-SparX clinical trial of ACLX-002 in patients with acute myeloid leukemia and high-risk myelodysplastic syndrome by year end. We’re continuing to build our organization, attracting exceptional talent and fostering a diverse and collaborative culture, allowing us to deliver on the incredible promise of our technology and company. I’m incredibly proud of our team who’ve driven these remarkable results and who make Arcellx a special place to be. Each and every one of us at Arcellx recognizes the potential for our therapy to save lives and to be a game-changer in how hematologic and solid tumors are treated. Collectively, our team is committed to maximizing the potential of our cell therapies for patients and the physicians who treat them."

Third Quarter 2022 Financial Highlights

Cash, cash equivalents, and marketable securities:
As of September 30, 2022, Arcellx had cash, cash equivalents, and marketable securities of $280.8 million, which is anticipated to fund its operations for at least the next 12 months.

R&D expenses:
Research and development expenses were $83.5 million and $12.3 million for the quarters

ended September 30, 2022 and 2021, respectively, an increase of $71.2 million. This increase was primarily driven by the accounting for a one-time, non-cash expense of $63.1 million related to Lonza manufacturing services agreements. In accordance with ASC 842, the Company was required to expense the related right of use asset associated with the embedded lease which was determined to have no alternative future use. Other increases were related to higher external costs associated with the advancement of the Company’s CART-ddBCMA clinical program, other pipeline candidates, and increased headcount.

G&A expenses:
General and administrative expenses were $10.4 million and $4.8 million for the quarters ended September 30, 2022 and 2021, respectively, an increase of $5.6 million. This increase was driven by increased headcount, and costs to operate as a public company during the three months ended September 30, 2022, as compared to the same period in 2021, including professional fees related to consulting and accounting, audit and legal services.

Net loss:
Net loss was $92.9 million and $17.1 million for the quarters ended September 30, 2022 and 2021, respectively.

On November 14, 2022 VBL Therapeutics (Nasdaq: VBLT), a clinical stage biotechnology company developing targeted medicines for immune-inflammatory diseases, reported financial results for the third quarter ended September 30, 2022, and provided a corporate update (Press release, VBL Therapeutics, NOV 14, 2022, View Source [SID1234624083]).

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"VBL’s management team and board continue to make good progress on the evaluation of strategic options for the company’s assets, including the GMP manufacturing facility and VB-601 program, with the goal of maximizing shareholder value," said Dror Harats, M.D., Chief Executive Officer of VBL. "We recently submitted our regulatory filings for a first-in-human clinical trial for the VB-601 program, and expect to initiate this trial in the first quarter of 2023, subject to the outcome of our strategic process."

Third Quarter Highlights

Filed a regulatory submission to the Israel Ministry of Health and institutional review board to conduct a Phase 1 first-in-human trial for its lead immunology product candidate,VB-601, a targeted antibody for immune-inflammatory applications.
Retained Chardan Capital to act as financial advisor to explore and evaluate strategic options for maximizing shareholder value.
Took steps to preserve capital, including the workforce reduction and ceasing internal development of ofra-vec.
Financial Results for the Third Quarter of 2022

At September 30, 2022, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $27.7 million. VBL expects that its cash, cash equivalents, short-term bank deposits, and restricted bank deposits will be sufficient to fund currently planned operating expenses and capital expenditures for at least twelve months. VBL’s ongoing review of its strategic options and any transactions resulting from such review may impact this projection.
For the quarter ended September 30, 2022, VBL reported a net loss of $9.2 million, or ($0.12) per basic share, compared to a net loss of $6.1 million, or ($0.09) per basic share, in the comparable period in 2021.
Revenues for the quarter ended September 30, 2022, were $0.5 million, as compared to $0.2 million in the comparable period in 2021.
For the quarter ended September 30, 2022, total operating expenses were approximately $9.7 million, consisting of $6.0 million in research and development expenses, net, and $3.7 million in general and administrative expenses. This compares with total operating expenses of $6.6 million in the quarter ended September 30, 2021, which was comprised of $5.0 million in research and development expenses, net, and $1.6 million in general and administrative expenses.