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Clarity Pharmaceuticals closes $25m capital raising

On December 15, 2020 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that it has completed a capital raising of $25,000,410 (Press release, Clarity Pharmaceuticals, DEC 15, 2020, View Source [SID1234572814]).

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Dr Alan Taylor, Executive Chairman of Clarity Pharmaceuticals, commented, "It has been a pivotal year for Clarity with numerous critical milestones achieved in the development of our main products, advancement of our platform, as well as accelerated corporate and strategic activities despite facing an unprecedented global environment.

"The money raised will enable us to keep the momentum from 2020 going and provide financial resources to progress the following important initiatives:

SARTATE
Progress the Cu-64/Cu-67 SARTATE Neuroblastoma trial at the Memorial Sloan Kettering Cancer Center in children with neuroblastoma;
Expand the Cu-64/Cu-67 SARTATE Neuroblastoma trial to additional clinical sites across the US with the ultimate goal of developing better treatment options for children with cancer; and
Commence patient recruitment in Phase II Cu-64 SARTATE Neuroendocrine trial.
SAR-Bombesin
Progress and expand the Cu-64 BOmbesin in Breast CAncer Trial (C-BOBCAT) led by A/Prof Louise Emmett, Director of Theranostics and Nuclear Medicine, at St Vincent’s Hospital in Sydney with an aim of developing better treatment options to women with metastatic breast cancer, an area currently with a high unmet need;
Expand the C-BOBCAT trial to include prostate cancer patients; and
Seek US Food and Drug Administration’s (FDA) approval for an Investigational New Drug (IND) Application.
SAR-bisPSMA
Commence a clinical trial in the US for Cu-64/Cu-67 SAR-bisPSMA (theranostic) and in Australia for Cu-64 SAR-bisPSMA (diagnostic) to build on the promising pre-clinical data with the help of an internationally recognised team of key opinion leaders in the prostate cancer field; and
Seek US FDA approval for an IND Application.
Develop new targeted theranostic products for a broad range of cancer types, utilising Clarity’s SAR Technology Platform and the Cu-64/Cu-67 pairing."
Dr Taylor continued, "Clarity has a strong focus on getting its lead product SARTATE to market, supported by the US FDA granting both Cu-67 SARTATE and Cu-64 SARTATE Orphan Drug Designations and Rare Paediatric Disease Designations for the treatment and clinical management of neuroblastoma, as well as developing the copper platform in large and unmet clinical indications."

"It has been a very exciting year for Clarity" Dr Taylor added. "We would like to sincerely thank our long-term shareholders for their continued support of Clarity, as well as welcome and thank a broad range of new shareholders including institutions, family offices, high net-worth individuals and others who wanted to be part of the Clarity story. We would also like to thank Blue Ocean Equities for their contribution in assisting us with the capital raise."

Oncternal Therapeutics Announces Closing of $86.2 Million Bought Deal and Full Exercise of Option to Purchase Additional Shares

On December 14, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported the closing of its previously announced public offering on a firm commitment basis of 19,161,667 shares of common stock of the Company, including the exercise in full by the underwriter of its option to purchase an additional 2,495,000 shares of common stock, at a price to the public of $4.50 per share, less underwriting discounts and commissions (Press release, Oncternal Therapeutics, DEC 14, 2020, View Source [SID1234576291]).

H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

The gross proceeds to Oncternal, before deducting underwriting discounts and commissions and offering expenses were approximately $86.2 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical and preclinical development of cirmtuzumab and TK216, preclinical development of its ROR1 CAR-T program, and for working capital.

The shares of common stock were offered by Oncternal pursuant to a "shelf" registration statement on Form S-3 (File No. 333-222268) previously filed with the Securities and Exchange Commission (the "SEC") on December 22, 2017 and declared effective by the SEC on January 5, 2018. The offering of the shares of common stock was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock offered has been filed with the SEC and is available on the SEC’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail 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.

PRESS RELEASE – Ergomed acquires MedSource, a US-based specialist oncology and rare disease CRO

On December 14, 2020 Ergomed plc (LSE: ERGO) ("Ergomed" or the "Company"), a company focused on providing specialised services to the pharmaceutical industry, reported the acquisition of MS Clinical Services, LLC ("MedSource"), a specialised clinical research organisation (CRO) based in Houston, Texas, USA (Press release, Ergomed Group, DEC 14, 2020, View Source [SID1234575064]).

Dr Miroslav Reljanović, Executive Chairman of Ergomed, said: "We are delighted to have delivered on our strategic goals in 2020 with the expansion of our US footprint in both the CRO and PV businesses. The addition of MedSource and its complementary expertise in oncology and rare disease will further establish Ergomed as a specialised services provider in the strategically important US market, building on the successful acquisition and integration of Ashfield Pharmacovigilance (now PrimeVigilance USA) earlier this year. We look forward to developing the potential of this new business to offer truly global clinical research services to our international customer base. We are excited to welcome the MedSource team to Ergomed and are eager to work alongside our new colleagues to leverage our combined expertise in complex therapeutic areas for the benefit of our clients and patients worldwide. Looking ahead to 2021 we expect to see continued momentum across the business as we look to increase our footprint in key geographies, and firmly establish Ergomed as a leading global provider of specialist services to the pharmaceutical industry."

Eric Lund, founder of MedSource who will continue in his current role as President of MedSource after the acquisition, said: "I am delighted to be joining the Ergomed Group and continuing my current role. We are confident that this is an important strategic step and natural fit for MedSource, as Ergomed is an exciting, fast-growing global company with a strong reputation in the CRO industry. Our own extensive experience in oncology and rare disease drug development and across product types, clinical trial phases and study designs will complement the services already offered to Ergomed’s international client base. The combined business will be of great benefit to our US clients and employees, providing a seamless service offering into Europe and globally."

Acquisition benefits
MedSource is a full-service CRO with a focus on complex diseases and study designs. MedSource delivers high-quality clinical trials specialising in oncology and rare disease. With over 20 years’ experience, MedSource has participated in more than 200 oncology and rare disease clinical trials.

The acquisition aligns with Ergomed’s strategy to grow its existing profitable services business both organically and through acquisition and advances a number of important strategic objectives for Ergomed, including:

Complementary specialism in oncology and rare disease. The two businesses have core expertise in complex disease areas. The combined business will enable an even greater degree of specialist expertise in high growth sectors of the overall pharmaceutical services market in which Ergomed specialises.

Expanded US presence. The acquisition will further accelerate Ergomed’s growth in the North American market, with additional offices in Houston, Raleigh and Boston in the USA, and Newcastle upon Tyne in the UK. The increased US presence, with the addition of over 110 US-based employees, is expected to drive substantial new awards in the region and increase Ergomed’s pipeline in both the CRO and PV businesses.

Significantly increases Ergomed’s order book. MedSource joins Ergomed with an existing order book of over $41 million, adding to Ergomed’s £151.4 million order book as reported in September 2020 in its H1 2020 interim results, providing high forward visibility of contracted future revenue.

Acquisition terms and MedSource trading history
Under the terms of the equity purchase agreement (the "EPA"), Ergomed has acquired MedSource for an initial consideration comprising $16.2 million in cash paid at the closing of the transaction, up to $1.8 million in Ergomed shares to be issued at a price based on the average daily closing price for 30 days preceding the acquisition and within 15 months of the closing of the transaction, subject to reduction for breaches of representations and warranties, and up to a further $7.0 million payable 90% in cash and 10% in shares depending on MedSource’s financial results in the year to 31 December 2021. The EPA includes customary provisions relating to normalised working capital and representations, warranties and indemnities.

The acquisition will be funded using the Company’s existing cash resources without significant depletion of cash available to fund future organic and inorganic growth.

In its financial year ended 31 December 2019, MedSource recorded total revenues of $31.3 million, comprising service fee revenue of $19.3 million and pass-through revenue of $12.0 million. In 2019 adjusted EBITDA was $1.3 million and net assets were $2.6 million.

The transaction is expected to be immediately accretive and earnings enhancing, with further growth and strategic benefits expected in future years.

Webcast and conference call for analysts:
A webcast and conference call for analysts will be held at 1pm GMT on Monday 14th December.

Modulus Discovery, Inc. to Present at the 39th Annual J.P. Morgan Healthcare Conference

On December 14, 2020 Modulus Discovery Inc. ("Modulus"), a pre-clinical stage technology-driven drug discovery company reported that it was invited to present at the 39th Annual J.P. Morgan Healthcare Conference in January 2021 (Press release, Modulus Discovery, DEC 14, 2020, View Source [SID1234574447]). The J.P. Morgan Healthcare Conference, which attracts over 500 companies and 12,000 investors, is going virtual for 2021, and the webcast will be made available online following the live event.

S. Roy Kimura, co-founder and CEO, will present on January 12, 2021 at 8:40 AM EST and will give a brief introduction to the company’s cutting edge simulation-based drug discovery platform and its maturing portfolio of small-molecule drug discovery projects in chronic inflammation, oncology, and infectious diseases including COVID and related RNA viruses. Following the event, the company will be available for meetings with interested parties to further describe its unique discovery platform and capabilities and lead programs currently in pre-clinical studies.

Comment from S. Roy Kimura, CEO, Modulus Discovery, Inc.
"We are delighted to be given this opportunity to introduce our company’s technology platform, small-molecule discovery capabilities, and unique portfolio of R&D programs. Our lead programs targeting chronic inflammation / autoimmune diseases and oncology are currently approaching the IND stage, and we would be happy to provide information about them to interested parties for potential clinical partnerships."

Regeneron Provides Update on Odronextamab Clinical Trials in B-cell Non-Hodgkin Lymphomas

On December 14, 2020 Regeneron reported that is pausing new enrollment of patients with B-cell non-Hodgkin lymphomas (B-NHL) in its trials for odronextamab, a CD20xCD3 bispecific antibody, in compliance with a U.S. Food and Drug Administration (FDA) partial clinical hold (Press release, Regeneron, DEC 14, 2020, View Source [SID1234572973]). The FDA requested that the company amend the trial protocols in order to further reduce the incidence of ≥Grade 3 cytokine release syndrome (CRS) during step-up dosing. Currently enrolled patients who are deriving clinical benefit from odronextamab may continue treatment following re-consent.

Patient safety is of the utmost concern to Regeneron. The company plans to submit a protocol amendment to the FDA with the goal of resuming patient enrollment early in the first quarter of 2021.

The two trials currently enrolling patients that are impacted are a Phase 1 monotherapy trial in B-NHL and chronic lymphocytic leukemia and a Phase 2 monotherapy trial in several B-NHL subtypes.