On May 29, 2024 Merus N.V. (Nasdaq: MRUS) ("Merus", the "Company," "we" and "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the pricing of an upsized underwritten public offering of 7,550,000 common shares, at a public offering price of $53.00 per share (the "Offer Shares") (Press release, Merus, MAY 29, 2024, View Source [SID1234643803]). Merus also granted the underwriters a 30-day option to purchase up to an additional 1,132,500 common shares (the "Option Shares" and together with the Offer Shares, the "Shares"). The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses and excluding the underwriters’ option to purchase the Option Shares, are expected to be approximately $400.2 million. All of the shares in the offering are to be sold by Merus.

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The offering is expected to close on or about May 31, 2024, subject to customary closing conditions.

Merus currently intends to use the net proceeds from the offering, together with its existing cash, cash equivalents and marketable securities, to advance the clinical development of its product candidates, for preclinical research and technology development, and for working capital and general corporate purposes.

Jefferies, BofA Securities, Leerink Partners, Guggenheim Securities and BMO Capital Markets are acting as joint book-running managers for the offering. Van Lanschot Kempen is acting as lead manager for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission (SEC) on February 28, 2024 and was effective upon filing. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, which, for the avoidance of doubt, will not constitute a "prospectus" for the purposes of (i) Regulation (EU) 2017/1129 (the "Prospectus Regulation") and has not been reviewed by any competent authority in any member state in the European Economic Area (the "EEA") and (ii) the Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018 (the "UK Prospectus Regulation") and has not been reviewed by the Financial Conduct Authority in the United Kingdom. A preliminary prospectus supplement to the prospectus describing the terms of the offering was filed with the SEC on May 28, 2024, and a final prospectus supplement will be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; BofA Securities NC1-0220-02-25, Attention: Prospectus Department, 201 North Tryon Street, Charlotte, NC 28255‐0001, or by email at [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525 ext. 6105, or by email at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected]; or BMO Capital Markets Corp., Attention: Equity Syndicate Department, 151 W 42nd Street, 32nd Floor, New York, NY 10036, by telephone at (800) 414-3627 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 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.

This press release is an advertisement and not a prospectus within the meaning of either the Prospectus Regulation or the UK Prospectus Regulation.

EEA:

In relation to each member state of the EEA (each, a "Relevant State"), no Shares have been offered or will be offered pursuant to the offering to the public in that Relevant State prior to the publication of a prospectus in relation to the Shares which has been approved by the competent authority in that Relevant State or, where appropriate, approved in another Relevant State and notified to the competent authority in that Relevant State, all in accordance with the Prospectus Regulation, except that Shares may be offered to the public in that Relevant State at any time:

to any legal entity which is a "qualified investor" as defined under Article 2 of the Prospectus Regulation;
to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; and
in any other circumstances falling within Article 1(4) of the Prospectus Regulation,
provided that no such offer of the Shares shall require us or any of the underwriters to publish a prospectus pursuant to Article 3 of the Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the Prospectus Regulation. Each person who initially acquires any Shares or to whom any offer is made will be deemed to have represented, warranted, acknowledged and agreed to and with us and each of the underwriters that it is a "qualified investor" within the meaning of Article 2 of the Prospectus Regulation.

For the purposes of the above, the expression "offer to the public" in relation to the Shares in any Relevant State means the communication in any form and by any means of sufficient information on the terms of the offer and any Shares to be offered so as to enable an investor to decide to purchase or subscribe for any Shares, and the expression "Prospectus Regulation" means Regulation (EU) 2017/1129.

United Kingdom:

No Shares have been offered or will be offered pursuant to this offering to the public in the United Kingdom prior to the publication of a prospectus in relation to the Shares which has been approved by the Financial Conduct Authority in the United Kingdom, except that the Shares may be offered to the public in the United Kingdom at any time:

a) to any legal entity which is a qualified investor as defined under Article 2 of the UK Prospectus Regulation;

b) to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the UK Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; or

c) in any other circumstances falling within Section 86 of the Financial Services and Markets Act 2000 (the "FSMA")

provided that no such offer of the Shares shall require us or any of the underwriters to publish a prospectus pursuant to Section 85 of the FSMA or Article 3 of the UK Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the UK Prospectus Regulation. Each person in the United Kingdom who initially acquires any Shares or to whom any offer is made will be deemed to have represented, warranted, acknowledged and agreed to and with us and each of the underwriters that it is a "qualified investor" within the meaning of the UK Prospectus Regulation.

For the purposes of this provision, the expression an "offer to the public" in relation to the Shares in the United Kingdom means the communication in any form and by any means of sufficient information on the terms of the offer and any Shares to be offered so as to enable an investor to decide to purchase or subscribe for any Shares.

In addition, in the United Kingdom, the transaction to which this press release relates will only be available to, and will be engaged in only with persons who are "qualified investors" (as defined in the UK Prospectus Regulation) (i) who have professional experience in matters relating to investments falling within Article 19(5) of the FSMA (Financial Promotion) Order 2005, as amended (the Order), and/or (ii) who are high net worth entities (or persons to whom it may otherwise be lawfully communicated) falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "relevant persons"). In the United Kingdom, the securities referred to herein are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with relevant persons. Any person in the United Kingdom who is not a relevant person should not act or rely on this communication or any of its contents.

On May 29, 2024 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, reported that the Company will present at the 2024 Jefferies Global Healthcare Conference on Wednesday, June 5, 2024 at 3:00 PM ET in New York, New York (Press release, Fate Therapeutics, MAY 29, 2024, View Source [SID1234643802]).

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A live webcast, if recorded, of each presentation can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website shortly after the event.

On May 29, 2024 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported new interim tumor response data from the ongoing randomized, controlled Phase 2b study of VBI-1901, the Company’s immunotherapeutic cancer vaccine candidate, in recurrent glioblastoma (rGBM) patients (Press release, VBI Vaccines, MAY 29, 2024, View Source [SID1234643801]). These data will be presented in a poster session at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Saturday, June 1, 2024.

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David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, said: "The tumor responses we have seen to date are incredibly encouraging, and, like the tumor responses did in the Phase 1/2a study, I am excited to see how this translates to clinical and survival outcomes later this year. The approved treatments for recurrent GBM patients have limited to no efficacy, which is consistent with the data seen in the standard-of-care arm in this study. VBI-1901’s ability to stimulate an immune response capable of generating a disease control rate of 43% at this interim stage of the study, including a partial response, is hopefully an indication of the potential of this candidate to make a meaningful difference in the lives of patients, providers, and families."

Jeff Baxter, VBI’s President and CEO, said: "These data represent a considerable advancement in our effort to make a difference in the fight against GBM. Throughout the remainder of 2024, we expect to have additional tumor response data and initial survival data. Pending the strength of these clinical data, we believe we can start discussions with the FDA around what an accelerated development and approval pathway looks like, under our Fast Track and Orphan Drug Designations."

Phase 2b Data Poster Highlights

As of May 15, 2024, 23 patients had been randomized 1:1 to either the active treatment arm, VBI-1901, or to the control treatment arm (standard-of-care).

Active Study Arm: VBI-1901 + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
11 patients have been randomized – tumor response data was available for 7 of those patients as of May 15, 2024
One (1) PR and two (2) SD observations seen to date
The patient with the PR saw a 67% tumor reduction compared to baseline at week 6, after receiving two monthly doses of VBI-1901
43% (n=3/7) disease control rate achieved in evaluable patients to date
2 additional patients appear to be experiencing stabilization of tumor growth after their second dose of VBI-1901, but do not yet meet the threshold to qualify as stable disease
Control Study Arm: Standard-of-Care (SoC) Therapy – Carmustine or Lomustine
12 patients have been randomized – tumor response data was available for 6 of those patients as of May 15, 2024
No tumor responses have been observed in the SoC arm (n=0/6; 0% DCR)
5 evaluable patients have experienced tumor progression of 2-8x increase in tumor size and have been taken off study protocol
Tumor response rates are an objective measure of treatment efficacy in oncology trials. In VBI’s previous Phase 1/2a study of VBI-1901 in rGBM, a 44% disease control rate was observed (n=7/16), which translated to clinical improvements in overall survival, with a median overall survival (mOS) of 12.9 months after treatment with VBI-1901 compared to the 8-month mOS historical benchmark for standard-of-care chemotherapy treatment.

ASCO Poster Details

Title: Randomized Phase 2b trial of a CMV vaccine immunotherapeutic candidate (VBI-1901) in recurrent glioblastomas
Abstract Number: TPS2100
Date & Time: 9:00 AM – 12:00 PM CDT, Saturday, June 1, 2024
Poster Session: Central Nervous System Tumors
VBI’s poster presentation will be made available on the Posters page of VBI’s website, under News and Resources, after the Central Nervous System Tumors poster session concludes on June 1, 2024.

Phase 2b Patient Enrollment Update

26 patients have been randomized as of May 28, 2024
Patient enrollment rate continues to increase, with six (6) patients randomized in May
VBI expects the study to be fully enrolled (n=60) by year-end 2024, subject to continued pace of enrollment
Phase 2b Study Design

Multi-center, randomized, controlled, open-label study in up to 60 patients with first recurrent GBM

Patients will be randomized in a 1:1 ratio across two study arms:
Intradermal VBI-1901 + GM-CSF: 10 µg dose every 4 weeks until clinical disease progression
Monotherapy standard-of-care: either intravenous carmustine or oral lomustine, every 6 weeks until disease progression or intolerable toxicity
Endpoints include:
Safety and tolerability
Overall survival (OS) – median and overall
Tumor response rate (TRR)
Progression-free survival (PFS)
Immunologic responses
Reduction in corticosteroid use relative to baseline
Change in quality of life compared to baseline
The randomized, controlled Phase 2b study is evaluating overall survival, tumor response rates, and safety and tolerability of VBI-1901 as a monotherapy treatment in rGBM patients. There are no effective, approved treatments available for patients with rGBM, and median overall survival remains low at approximately eight (8) months.

The U.S. Food and Drug Administration (FDA) has considered demonstration of a statistically significant improvement in overall survival relative to a randomized control arm to be clinically significant and has recognized this as criteria to support the approval of new oncology drugs.1

For more information about the Phase 2b study, visit clinicaltrials.gov and reference trial identifier: NCT03382977.

Phase 1/2a Study Data Highlights – VBI-1901 10µg + GM-CSF Study Arms

(n=16)

44% disease control rate achieved (n=7/16) – disease control rate is defined as stable disease (SD) + partial tumor response (PR) + complete tumor response (CR)
2 partial responses (PR) were observed – 1 patient was on treatment for more than 28 months (2.33 years), surviving at least 40 months (3.33 years) as of August 1, 2023, with a maximum tumor reduction of 93% relative to baseline
5 additional patients demonstrated stable disease (SD) for a sustained period of time
All patients with a tumor response (PR or SD) (n=7/16) reached a minimum survival of 12 months
Median overall survival (mOS) was 12.9 months, comparing favorably to 8-month mOS for monotherapy standard-of-care2
About GBM and VBI-1901

Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. The FDA has granted VBI-1901 Fast Track Designation and Orphan Drug Designation for the treatment of recurrent glioblastoma. These designations are intended to provide certain benefits to drug developers, including more frequent meetings with the FDA, and Accelerated Approval and Priority Review, if relevant criteria are met, among other benefits.

References

1. Oncology Center of Excellence, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics; Guidance for Industry. FDA.gov. December, 2018

2. Taal W, Oosterkamp HM, Walenkamp AME, et al. Single-agent bevacizumab or lomustine versus a combination of bevacizumab plus lomustine in patients with recurrent glioblastoma (BELOB trial): a randomized controlled phase 2 trial. Lancet Oncol. 2014; 15: 943-953

On May 29, 2024 StarkAge Therapeutics, a French biotechnology company, reported a €1.2 million fundraising round conducted with biotech focused business angels and BPI (Press release, StarkAge Therapeutics, MAY 29, 2024, View Source [SID1234643800]). The company, founded in 2018, specializes in the targeting of cellular senescence in the onctext of age-related pathologies, especially cancer.

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Currently, cancers are mainly treated with radiotherapy, chemotherapy and/or targeted therapy. These therapies can lead to the emergence of senescent cells within the tumor and in adjacent normal tissues. Senescent cancer cells are implicated in treatment resistance, metastasis, and numerous side-effects including fibrosis. StarkAge Therapeutics’ mission is to identify specific targets expressed at the plasma membrane of senescent cells to develop targeted therapies and thus improve patients’ response to conventional therapies.

This funding round will enable the company to finalize in vivo testing of its first lead candidate, STX-1, an Antibody-Drug Conjugated (ADC) directed against the transmembrane protein DPP4 (CD26), highly overexpressed by senescent cells. The preliminary in vitro and in vivo results already obtained, particularly in liver and prostate cancer models, are extremely promising and applicable to a wide variety of other types of cancer expressing DPP4.

« We would like to thank all our partners for their support and confidence. Our ambition is to develop a highly innovative therapeutic approach based on the elimination of senescent cells in patients with refractory cancers, to increase their chances of recovery while limiting functional side effects. With this fundraising, we will finalize the in vivo experiments and initiate our second research program, STX-2. We hope to initiate a new round of financing in September 2024 to complete the preclinical studies for STX-1, prepare our entry into the clinic and continue the preclinical development of our STX-2 program, » explains Dr Thierry Mathieu, Founder and CEO of StarkAge Therapeutics.

The company is also focusing on research program, notably through a partnership with Professor Myriam Gorospe at the National Institute of Health (NIH), a world-renowned specialist in the field of cellular senescence. This collaboration will enable us to better understand the involvement of the DPP4 protein in age-related diseases, and to extend the STX-1 program to other therapeutic indications.

StarkAge Therapeutics’ research associated to an increasing number of scientific publications, demonstrate that the accumulation of senescent cells during disease progression is often extremely deleterious for patients. Many age-related diseases, such as pulmonary fibrosis, neurodegenerative and cardiovascular diseases, metabolic dysfunctions, liver fibrosis and cancer, are directly related to senescent cells and their accumulation in the human body. Targeting them opens the way to numerous innovative targeted therapies.

On May 29, 2024 Scorpius Holdings, Inc (NYSE American: SCPX) (‘Scorpius" or "the Company"), an integrated contract development and manufacturing organization ("CDMO"), reported strategic, financial, and operational updates for the first quarter ended March 31, 2024 (Press release, Scorpius BioManufacturing, MAY 29, 2024, View Source [SID1234643799]).

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Jeff Wolf, CEO of Scorpius Holdings, Inc., stated, "We are successfully executing our strategy to enhance revenue and reduce costs as we seek to become cash flow positive in the near future. This quarter is indicative of this goal as we achieved a 359% increase in revenue while reducing operating expenses by 34% over the same period last year. We believe this performance reinforces the growing demand for our services and our prudent financial management. Moreover, we have built a highly scalable business model poised to generate meaningful cash flow as we continue to grow our sales and increase utilization of our state-of-the-art San Antonio campus, which we anticipate will allow us to achieve meaningful operating leverage. We are very confident that the future for Scorpius is brighter than ever, with significant industry-wide capacity shortages, and our growing revenue backlog, which stood at $10.8 million as of March 31, 2024."

2023 Financial Results

For the three months ended March 31, 2024, the Company recognized $3.5 million of revenue from process development. For the three months ended March 31, 2023, the Company recognized $0.7 million of process development revenue and $0.1 million of license revenue. The increase in process development revenue was attributable to the expanded biomanufacturing operations and service offerings of the CDMO.

Cost of revenues were $0.9 million and $0.6 million for the three months ended March 31, 2024, and 2023, respectively, and primarily consisted of the direct cost of labor, overhead and material costs at Scorpius. The increase in cost of revenues was due to the expanded service offerings and completed milestone work on multiple CDMO contracts.

Research and development expenses were $3.9 million for the three months ended March 31, 2024, compared to $6.3 million for the three months ended March 31, 2023.

Selling, general and administrative expenses were $5.0 million and $6.5 million for the three months ended March 31, 2024, and 2023, respectively. The decrease of $1.5 million was primarily due to decreases in marketing expense of $0.5 million, consultant labor of $0.5 million, and stock-based compensation of $0.5 million.

For the three months ended March 31, 2024, the change in fair value of contingent earn-out receivable, related party, was $1.0 million. This change was primarily due to an increase in expected value of the earn-out due to a new contract received by Elusys Therapeutics.

Total non-operating income was $0.7 million for the three months ended March 31, 2024, which primarily consisted of $1.0 million from the sale of an intellectual property license, partially offset by $0.2 million of interest expense on finance leases, and $0.1 million change in fair value of convertible promissory note, related party. Total non-operating income was $0.1 million for the three months ended March 31, 2023, which primarily consisted of $0.2 million of interest income, $0.1 million of unrealized gain on short-term investment balances, partially offset by $0.2 million of interest expense on finance leases and other expense.

Net loss attributable to Scorpius was approximately $4.4 million, or ($0.16) per basic and diluted share, for the three months ended March 31, 2024, compared to approximately $12.8 million, or ($0.49) per basic and diluted share, for the three months ended March 31, 2023.

As of March 31, 2024, the Company had approximately $1.7 million in cash, cash equivalents, and short-term investments. On May 16, 2024, the Company consummated a public offering resulting in aggregate gross proceeds of approximately $6.0 million, before deducting underwriting discounts and other offering expenses.