March 2023 – Page 209 – 1stOncology™: Cancer Intelligence Service

Revolution Medicines Announces Pricing of $300.0 Million Public Offering of Common Stock

On March 3, 2023 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported the pricing of its underwritten public offering of 13,636,364 shares of common stock at a public offering price of $22.00 per share, before underwriting discounts and commissions (Press release, Revolution Medicines, MAR 3, 2023, View Source [SID1234628077]). All of the shares of common stock are being offered by Revolution Medicines. In addition, Revolution Medicines has granted the underwriters a 30-day option to purchase up to an additional 2,045,454 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Revolution Medicines, are expected to be $300.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on March 7, 2023, subject to customary closing conditions.

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J.P. Morgan, TD Cowen, SVB Securities and Guggenheim Securities are acting as the joint book-running managers for the offering. UBS Investment Bank is acting as lead manager.

A shelf registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission (SEC) on March 2, 2021, and automatically became effective upon filing. This offering is being made solely by means of a prospectus. A copy of the final prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the final prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by email at [email protected] or by telephone at (833) 297-2926; SVB Securities LLC, 53 State Street, 40th Floor, Boston, MA 02109, Attention: Syndicate Department, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or: Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, 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 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.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Aeglea BioTherapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Aeglea BioTherapeutics, 2023, MAR 2, 2023, View Source [SID1234628064]).

DBV Technologies Reports Full Year 2022 Financial Results and Business Update

On March 2, 2023 Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, reported financial results for the full year 2022 (Press release, DBV Technologies, MAR 2, 2023, View Source [SID1234628113]). The audit procedures have been substantially completed by the Company’s statutory auditors and financials – prepared under both US GAAP and IFRS for the purpose of Form 10-K and Universal Registration Document respectively – were approved by the Board of Directors on March 2, 2023.

EVOLVE

DBV completed EVOLVE, a 12-week caregiver and patient user experience study of the modified Viaskin Peanut patch in 50 peanut allergic children ages 4 – 11-years old. The objective of EVOLVE was to evaluate the Instructions for Use (IFU) and ease of use for the modified Viaskin Peanut patch. The study concluded that the updated Viaskin Peanut IFU supported correct patch application, which included no lifting of the patch edges or detachment directly after application. Furthermore, EVOLVE concluded that the majority of parents/caregivers reported a positive ease of use experience with the modified Viaskin Peanut patch.

In EVOLVE, DBV also tested the functionality of an electronic patient diary (eDiary) to collect information on activities of daily living and patch adhesion scores. As previously announced, VITESSE will assess patch adhesion of the modified Viaskin Peanut patch and DBV will include a statistical test of adhesion in the VITESSE statistical analysis plan. EVOLVE verified that the eDiary tool can be used by caregivers in VITESSE to capture the adhesion data in support of a potential BLA application.

Financial Highlights for the Full Year 2022

The Company’s annual consolidated financial statements are prepared in accordance with both generally accepted accounting principles in the U.S. ("US GAAP") and International Financial Reporting Standards ("IFRS") as adopted by the European Union. Unless otherwise indicated, the financial figures in the Full Year 2022 Financial Highlights are presented under both U.S GAAP and IFRS financial statements, and commented using U.S. GAAP financial statements. Differences between US GAAP and IFRS consolidated financial statements are mainly due to discrepancies arising from the application of lease accounting standards.

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Cash and Cash Equivalents

US GAAP IFRS
Year ended December 31, Year ended December 31,
In millions of USD 2022 2021 2022 2021
Net cash & cash equivalents at the beginning of the period

77,3 196,4 77,3 196,4
Net increase / (decrease) in cash & cash equivalents, of which:

131,9 (119,1 ) 131,9 (119,1 )
Net cash flow used in operating activities

(55,7 ) (108,2 ) (51,4 ) (104,1 )
Net cash flow used in investing activities

(0,1 ) (0,4 ) (0,1 ) (0,4 )
Net cash flow provided by / (used in) financing activities

194,1 0,3 189,9 (3,9 )
Effect of exchange rate changes on cash & cash equivalents

(6,5 ) (10,7 ) (6,5 ) (10,7

Net cash & cash equivalents at the end of the period

209,2 77,3 209,2 77,3

Cash and cash equivalents amount to $209,2 million as of December 31, 2022, compared to $77,3 million as of December 31, 2021, which is an increase by $131,9 million due to:

(1)
$194,1 million due to financing activities, mainly from ATM Program in May 2022 ($14,1 million, net of transaction costs), then from private investment in public equity ($180,4 million, net of transaction costs);

(2)
$26,1 million reimbursed by French tax administration for research tax credits related to years 2019, 2020, and 2021;

And partially offset by :

(3)
$81,8 million of cash used for operations, before $26,1 million reimbursement of research tax credits. This is a decrease of 24% compared to prior year reflecting the cost containment measures that has been continuously maintained since their implementation in 2020.

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US GAAP IFRS
In millions of USD FY22 FY21 FY20 FY22 FY21 FY20
Net cash flow used in operating activities

55,7 108,2 165,6 51,4 104,1 160.9
Reimbursements of Research Tax Credits

26,1 — — 26,1 — —
Net cash flow used in operating activities, excluding reimbursements of Research Tax Credits

81,8 108,2 165,6 77,5 104,1 160,9
Compared to prior year

-26,4 -57,4 -26,6 -56,8
-24 % -35 % -26 % -35 %

(4)
$6,5 million negative impact of changes in exchange rates.

The Company’s treasury position, stated in US Dollars, has benefited in the last quarter from a change in the Euro to US Dollar exchange rate. The company’s activities and expenditures in the fourth quarter were in line with expectations and continue to reflect DBV’s expense discipline.

Operating Income

US GAAP IFRS
Year ended December 31, Year ended December 31,
In millions of USD 2022 2021 Variation 2022 2021 Variation
Research tax credits

5,7 7,5 -1,8 -24 % 5,7 7,5 -1,8 -24 %
Other operating income

(0,9 ) (1,8 ) +0,9 -51 % (0,9 ) (1,8 ) +0,9 -51

Produits opérationnels

4,8 5,7 -0,9 -15 % 4,8 5,7 -0,9 -15

Operating income amounts to $4,8 million as of December 31, 2022, compared to $5,7 million as of December 31, 2021, which is a decrease by $0,9 million due to:

(1)
A decrease in 2022 research tax credit by $1.8 million compared to 2021. This reflects the impact of the global restructuring plan initiated in 2020 and completed in 2021 which has impacted the expenses eligible to the research tax credit.

(2)
Partially offset by the variance in other operating income that consists of revenues recognized in advance of the completion of the collaboration agreement with Nestlé Health Science ("NHS").

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Operating Expenses

US GAAP IFRS
In millions of USD Year ended December 31, Year ended December 31,
2022 2021 Variation 2022 2021 Variation
Research & Development

75,5 70,3 +5,2 +7 % 75,2 70,1 +5,1 +7 %
Sales & Marketing

1,6 4,4 -2,8 -63 % 1,6 4,4 -2,8 -65 %
General & Administrative

24,3 30,5 -6,2 -20 % 24,2 30,4 -6,1 -20 %
Restructuring

— (0,9 ) +0,9 -100 % — (0,9 ) +0,9 -100

Total operating expenses

101,5 104,3 -2,8 -3 % 101,0 104,0 -2,9 -3

including personnel expenses

24,0 31,1 -7,1 -23 % 24,0 31,1 -7,1 -23 %
Operating expenses amount to $101,5 million as of December 31, 2022, compared to $104,3 million as of December 31, 2021, which is a decrease by $2,8 million mainly due to the decrease in personnel expenses as a result of the global restructuring plan that was announced in 2020 and completed in the course of 2021. The average number of employees was 86 for the year ended December 31, 2022, compared to 101 and 270 for the years ended December 31, 2021 and 2020 respectively.

This reduction in our operating expenses also reflects the strict financial discipline maintained across all services to focus our resources on the support of our clinical trial objectives.

Net Loss and Net Loss per Share

US GAAP IFRS
Year ended December 31, Year ended December 31,
2022 2021 Variation 2022 2021 Variation
Net (loss) in millions of USD

(96,3 ) (97,8 ) +1,5 -2 % (96,0 ) (98,1 ) +2,0 -2 %
Basic / diluted net (loss) per share in USD

(1,24 ) (1,78 ) +0,5 -30 % (1,24 ) (1,79 ) +0,6 -31 %
Net result for the year ended December 31, 2022, is a loss amounting to $96,3 million compared to a loss amounting to $97,8 million for the year ended December 31, 2021.

On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) is $1.24 for the year ended December 31, 2022.

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Conference Call Information DBV will host a conference call and live audio webcast today, Thursday, March 2, 2023, at 5:00 p.m. ET to report fourth quarter 2022 financial results and provide a

business update.

Attendees may access the call via the below teleconferencing numbers and asking to join the DBV Technologies call:

•
United States: 1-866-777-2509

•
International: 1-412-317-5413

A live webcast of the call will be available on the Investors & Media section of the Company’s website: View Source A replay of the presentation will also be available on DBV’s website after the event

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CONDENSED STATEMENT OF CONSOLIDATED FINANCIAL POSITION

US GAAP IFRS
Year ended December 31, Year ended December 31,
In millions of USD 2022 2021 2022 2021
Assets

246,5 146,7 246,5 146,3
of which cash & cash equivalents

209,2 77,3 209,2 77,3
Liabilities

52,1 47,4 52,0 47,3
Shareholders’ equity

194,5 99,3 194,5 99,0
of which net result

(96,3 ) (97,8 ) (96,0 ) (98,1 )
CONDENSED STATEMENT OF CONSOLIDATED OPERATIONS AND COMPREHENSIVE LOSS

US GAAP IFRS
In millions of USD Year ended December 31, Year ended December 31,
2022 2021 2022 2021
Revenues

4,8 5,7 4,8 5,7
Research & Development

(75,5 ) (70,3 ) (75,2 ) (70,1 )
Sales & Marketing

(1,6 ) (4,4 ) (1,6 ) (4,4 )
General & Administrative

(24,3 ) (30,5 ) (24,2 ) (30,4 )
Restructuring income/(expenses)

— 0,9 — 0,9
Operating expenses

(101,5 ) (104,3 ) (101,0 ) (104,0 )
Finance income/(expenses)

0,4 0,4 0,3 (0,2 )
Income tax

(0,1 ) 0,4 (0,1 ) 0,4
Net gain/(loss)

(96,3 ) (97,8 ) (96,0 ) (98,1 )
Résultat de base et dilué par action ($/action)

(1,24 ) (1,78 ) (1,24 ) (1,79 )
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CONDENSED STATEMENT OF CONSOLIDATED CASH FLOW

US GAAP IFRS
Year ended December 31, Year ended December 31,
In millions of USD 2022 2021 2022 2021
Net cash flows provided / (used) in operating activities

(55,7 ) (108,2 ) (51,4 ) (104,1 )
Net cash flows provided / (used) in investing activities

(0,1 ) (0,4 ) (0,1 ) (0,4 )
Net cash flows provided / (used) in financing activities

194,1 0,3 189,9 (3,9 )
Effect of exchange rate changes on cash & cash equivalents (US GAAP presentation)

(6,5 ) (10,7

Net increase / (decrease) in cash & cash equivalents

131,9 (119,1 ) 138,4 (108,4

Net cash & cash equivalents at the beginning of the period

77,3 196,4 77,3 196,4
Effect of exchange rate changes on cash & cash equivalents (IFRS presentation)

(6,5 ) (10,7

Net cash & cash equivalents at the end of the period

209,2 77,3 209,2 77,3

EPO Decision to Grant European Patent for Rencofilstat Further Strengthens Hepion’s Patent Portfolio

On March 2, 2023 Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH"), fibrotic diseases, hepatocellular carcinoma ("HCC"), and other chronic diseases, reported that the European Patent Office ("EPO") has granted European Patent No. EP 3886813, covering the innovative formulation of Hepion’s lead cyclophilin inhibitor, rencofilstat (Press release, Hepion Pharmaceuticals, MAR 2, 2023, View Source [SID1234628081]).

The newly granted European patent also significantly extends the time period of Hepion’s patent exclusivity for rencofilstat. The Company’s original composition-of-matter patent estate, comprising 52 patents issued in every major market throughout the world, are expected to provide exclusivity to 2036. The newly granted rights, which will encompass 38 European countries, are expected to extend the drug candidate’s patent life by approximately eight years, to 2044. Additional filings are also underway to potentially extend composition-of-matter and method-of-manufacturing exclusivity until 2048. In addition to the indications covered in the original composition-of-matter patents (viral, cardiovascular, neurological, and inflammatory diseases), Hepion has also filed various method-of-use patent applications covering a variety of additional indications (fibrosis, cancer, and thrombosis).

Robert Foster, PharmD, PhD, Hepion’s Chief Executive Officer, stated, "Rencofilstat is very challenging to formulate, owing to the physical-chemical properties of the molecule. Nevertheless, as awareness of its potential to address a number of significant unmet medical needs across a variety of indications continues to grow amongst researchers and drug developers in global markets, it is important this opportunity is well protected. To that end, our expanding intellectual property estate, including this new European patent, should ensure that rencofilstat has long-term market exclusivity."

Porton Advanced Collaborates with DanausGT to Accelerate the Development of Gene and Cell Therapy

On March 2, 2023 Porton Advanced Solutions Ltd. (Porton Advanced) and DanausGT Biotechnology Co., Ltd. (DanausGT) reported on February 27, 2023, a strategic collaboration in gene and cell therapy pipelines to expedite the development of innovative therapeutics (Press release, Porton Advanced Solutions, MAR 2, 2023, View Source [SID1234628105]).

As an end-to-end gene and cell therapy service provider, Porton Advanced CDMO offers comprehensive solutions covering plasmids, cell therapy, gene therapy, oncolytic virus, mRNA therapy, and bacterial therapy. On the other hand, DanausGT focuses on researching, developing, and producing new anti-cancer drugs and rare diseases with gene editing technology. DanausGT has established multiple R&D pipelines, and Porton Advanced will offer gene and cell therapy CDMO solutions to DanausGT, including plasmid, virus, and cell therapy products.

"We are excited to partner with DanausGT as their proprietary CRISPR/AAV technology is widely recognized. Their seven research pipelines are highly competitive, covering all the stages from pre-clinical to Clinical Phase I. Through our end-to-end gene and cell therapy CDMO, we hope to help DanausGT achieve IND approval for multiple pipelines and advance the development pipeline from domestic and overseas into the clinical stage. This collaboration will accelerate the development of innovative CGT therapeutics," said Dr. Wang Yangzhou, CEO of Porton Advanced.

"We are pleased to establish strategic cooperation with Porton Advanced. I believe this partnership will expedite the development of innovative gene cell therapy. We are looking forward to collaborating in more fields," said Dr. Wang Haifeng, founder, and CEO of DanausGT.

During the signing ceremony, Professor Jose Carlos Segovia, co-founder and CSO of DanausGT, presented a lecture entitled "Ex Vivo Gene Editing as a Definitive Cure for Hemolytic Anemias" and introduced the latest research progress of DanausGT. "We make gene editing technology and cell therapy to treat various diseases and work on therapy development for patient-centered care and clinical value. We look forward to collaborating with Porton Advanced to bring innovative biopharmaceuticals to patients earlier and deliver innovative values to society and the industry," Professor Segovia said.

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Month: March 2023

Revolution Medicines Announces Pricing of $300.0 Million Public Offering of Common Stock

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

DBV Technologies Reports Full Year 2022 Financial Results and Business Update

EPO Decision to Grant European Patent for Rencofilstat Further Strengthens Hepion’s Patent Portfolio

Porton Advanced Collaborates with DanausGT to Accelerate the Development of Gene and Cell Therapy