On March 20, 2023 FORE Biotherapeutics (FORE Bio) a precision stage oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead program, FORE8394, for the treatment of primary brain and central nervous system (CNS) malignancies (Press release, Fore Biotherapeutics, MAR 20, 2023, View Source [SID1234629068]). This is the first orphan drug designation received by FORE Bio and the FORE8394 program.

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FORE8394 is an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF being evaluated in FORTE, a global Phase 2 clinical study in adult and pediatric participants with advanced unresectable solid or primary CNS tumors harboring BRAF alterations (NCT05503797).

"The receipt of Orphan Drug Designation is another important regulatory achievement that reinforces the FDA’s recognition of the potential of FORE8394 to improve clinical outcomes in patients with BRAF-altered brain tumors," said Stacie Shepherd, M.D., Ph.D., Chief Medical Officer of Fore Biotherapeutics. "This designation will help us continue to expedite the development of our novel BRAF inhibitor, and we look forward to working closely with the global investigator community supporting FORTE and to advancing the development of FORE8394 for patients in need."

Matthew Ros, FORE’s CEO, commented, "available treatments are limited for patients with primary recurrent CNS tumors or those patients living with solid tumors with a BRAF fusion. With its unique mechanism of action as a paradox breaker, we believe we have a significant opportunity to deliver a novel and best in class potential therapeutic option with FORE8394. We look forward to accelerating enrollment in the Phase 2 Forte master protocol throughout 2023."

Orphan Drug Designation is granted to drugs or biological products for the treatment of rare diseases or conditions that impact fewer than 200,000 people in the United States. FORE8394 was granted Fast Track Designation by the U.S. Food and Drug Administration in September 2022 for the treatment of patients with cancers harboring BRAF Class 1 (V600) and Class 2 (including fusions) alterations who have exhausted prior therapies.

About FORE8394

FORE8394 is an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF. It was designed to target a wide range of BRAF mutations while sparing wild-type forms of RAF. Preclinical studies and clinical trials have shown that its unique mechanism of action effectively inhibits not only the constitutively active BRAFV600 monomers targeted by first-generation RAF inhibitors but also disrupts constitutively active dimeric BRAF class 2 mutants, fusions, splice variants and others. Unlike first-generation RAF inhibitors, FORE8394 does not induce paradoxical activation of the RAF/MEK/ERK pathway. As a "paradox breaker," FORE8394 could therefore treat acquired resistance to current RAF inhibitors and, more generally, yield improved safety and more durable efficacy than first-generation RAF inhibitors. The company previously announced interim data from the ongoing Phase 1/2a clinical trial evaluating FORE8394 in advanced solid and CNS tumors with activating BRAF alterations, providing evidence of durable anti-tumor activity in patients with BRAF-mutated (V600+) cancers. The data were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO) (Free ESMO Whitepaper) in September 2022. Mature data from the Phase 1/2a clinical trial is expected in mid-2023.

On March 20, 2023 Abcam plc (Nasdaq: ABCM) (‘Abcam’, the ‘Group’ or the ‘Company’), a global leader in the supply of life science research tools, reported its results for the year ended 31 December 2022 (the ‘period’) (Press release, Abcam, MAR 20, 2023, View Source;final-results-for-the-year-ended-31-december-2022-301775644.html [SID1234629067]).

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SUMMARY PERFORMANCE

Year-End 31 December

2022

£m

2021

£m

Revenue

361.7

315.4

Gross profit margin, %

Adjusted gross profit margin, %

74.8%

75.5%

71.2%

72.2%

Operating profit margin, %

Adjusted operating profit margin, %

Diluted (loss) / earnings per share (‘EPS’) (£)

(2.8%)

21.1%

(0.037)

2.3%

19.2%

0.019

Adjusted diluted earnings per share (‘EPS’) (£)

0.249

0.206

Return on Capital Employed (‘ROCE’), %

8.9 %

7.6 %

FULL YEAR FINANCIAL HIGHLIGHTS[1]

Reported revenue growth of 15%; constant exchange rate (‘CER’) revenue growth of 8%
– In-house revenues, including BioVision and Custom, Products & Licensing, recorded 26% reported revenue growth and 18% CER revenue growth
Reported gross profit margin of 74.8%: Adjusted gross profit margin of 75.5%, an increase of 330 basis points from 72.2%, driven by the contribution of in-house revenues, including BioVision and Custom, Products & Licensing
Operating loss of £10.1 million impacted by £18.3 million impairment charge on asset held for sale; adjusted operating profit increased 26% to £76.3m, resulting in a 190 basis points increase of adjusted operating profit margin to 21.1%
Diluted loss per share of (£0.037) impacted by impairment charge on asset held for sale; adjusted diluted earnings per share increased 21% to £0.249
Return on capital employed increased to 8.9%, a 130-basis point improvement, favourably impacted by efficient capital utilization and higher adjusted operating profits
[1] These results include discussion of alternative performance measures which include revenues calculated at Constant Exchange Rates (CER) and adjusted financial measures. CER results are calculated by applying prior period’s actual exchange rates to this period’s results. Adjusted financial measures are reconciled to the most directly comparable measure prepared in accordance with IFRS in note 3 to the financial statements.

BUSINESS HIGHLIGHTS

In-house revenues, including BioVision and Custom, Products & Licensing, represent 67% of total sales, an increase of 600 basis points
– Academic & Biopharmaceutical customers experienced double-digit percent reported revenue growth, Academic grew mid-single digits and Biopharmaceutical grew double-digit percent on a CER basis
Partnering with biopharma, diagnostic and multiplex platform partners continued to generate current and future sources of growth with the number of commercialized antibodies with these partners rising to a total of more than 2,100
To support future growth, we’ve implemented an Oracle Cloud ERP system, and expanded sites in Waltham, Singapore, and Amsterdam
Expanded Life Science Industry experience within the Board of Directors with the appointment of Luba Greenwood, as Non-Executive Director
Cancellation of admission to trading on AIM completed and sole Nasdaq listing as of 14 December 2022
FY23 OUTLOOK

The Company anticipates reported revenues of approximately £420 million to £440 million, representing 15% to 20% constant exchange rate revenue growth, combined with lower operating expense growth, resulting in adjusted operating profit margin expansion.

FY2024 GOAL

The Company is reiterating its 2024 revenue goals of £450m-£525m with adjusted operating profit margins of greater than 30%.

Commenting on the performance, Alan Hirzel, Abcam’s Chief Executive Officer, said:

"Our team is dedicated to supporting life science discovery, and the translation of discovery to social impact. In the last ten years, our business has grown revenue at double digit rates because of the trust the market has in our team, our innovation, and our brand. As we look ahead, we can be confident that we have and continue to build a sustainable and profitable growth company. I am grateful to everyone at Abcam for their ongoing efforts through this exciting period. I also thank our customers and partners bringing Abcam into their labs and giving us all the opportunity to demonstrate our company’s role in making progress happen together."

Analyst and investor meeting and webcast:

Abcam will host a conference call and webcast for analysts and investors today at 12:00 GMT/ 08:00 EDT. For details, and to register, please visit corporate.abcam.com/investors/reports-presentations

A recording of the webcast will be made available on Abcam’s website, corporate.abcam.com/investors

The information communicated in this announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014.

For further information please contact:

Abcam

+ 44 (0) 1223 696 000

Alan Hirzel, Chief Executive Officer

Michael Baldock, Chief Financial Officer

Tommy Thomas, Vice President, Investor Relations

On March 20, 2023 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported that the Company will report financial results for the full year ended December 31, 2022 before the market opens on Friday, March 31, 2023, and host a conference call to discuss the results and provide a corporate update at 8:15 a.m. EST (Press release, I-Mab Biopharma, MAR 20, 2023, View Source [SID1234629066]).

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I-Mab Conference Call Information

Investors and analysts are invited to join the conference call at 8:15 a.m. EST on March 31 via Zoom:
Link: View Source
Meeting ID: 852 0704 2705
Password: 782962

On March 20, 2023 The management team of Transcenta Holding Limited (06628.HK) reported that it will attend the 2022 annual results release conference call on March 31, 2023 (Press release, Transcenta, MAR 20, 2023, View Source [SID1234629064]). Transcenta is a clinical stage biopharmaceutical company with fully integrated capabilities in the discovery, research, development and manufacture of antibodies-based therapeutics.

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Meeting Details:

MeetingDate:

Friday, March 31, 2023

Meeting time:

10:00 a.m. (Beijing time)

Meeting Language:

English

Attendance Management:

Dr. Xueming Qian, Chief Executive Officer

Dr. Caroline Germa, EVP, Global Medicine Development and CMO

Mr. Daniel Weng, EVP, CFO

Ms. Vivian Wang, VP, Investor Relations & Capital Markets, Board Secretary

Enrollment form:

Please scan the QR code to register

(please register before March 27, 2023)

View Source

On March 20, 2023 ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, reported the closing of its previously announced purchase and sale of 1,071,429 shares of its common stock (or common stock equivalents) and warrants to purchase up to 1,071,429 shares of its common stock at a purchase price of $2.80 per share of common stock (or common stock equivalent) and associated warrant in a private placement priced at-the-market under Nasdaq rules (Press release, Thermogenesis, MAR 20, 2023, View Source [SID1234629063]). The warrants have an exercise price of $2.65 per share, are exercisable immediately upon issuance and expire five and one-half years following the issuance.

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H.C. Wainwright & Co. was the exclusive placement agent for the offering.

The gross proceeds to the Company are approximately $3 million. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.

The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements.

The Company has amended certain existing warrants to purchase up to an aggregate of 158,731 shares of the Company’s common stock that were previously issued in October 2022 and have exercise price of $6.30 per share by reducing the exercise price of the warrants to $2.65 per share.

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.