SEC Filing | Gyre Therapeutics, Inc

View:

Download DOC

Download PDF

Download XLS

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): March 20, 2023

Catalyst Biosciences, Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware	000-51173	56-2020050
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

611 Gateway Blvd Suite 120 South San Francisco, CA		94080
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: (650) 871-0761

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☒	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock		CBIO		The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01

Regulation FD Disclosure.

On March 20, 2023, Dr. Nassim Usman, on behalf of Catalyst Biosciences, Inc. (the “Company”), gave a presentation (the “Corporate Presentation”). In addition, the Company posted the Corporate Presentation on its website, ir.catalystbiosciences.com. A copy of the Corporate Presentation is attached hereto as Exhibit 99.1.

The information in this Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in this Current Report shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01

Financial Statements and Exhibits

(d) Exhibits

Exhibit Number		Description
99.1		Catalyst Biosciences March 20, 2023 Corporate Presentation Slide Deck.
104		Cover Page Interactive Data File (formatted as Inline XBRL).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	CATALYST BIOSCIENCES, INC.

Date: March 20, 2023	By:	/s/ Nassim Usman, Ph.D.
		Nassim Usman, Ph.D.
		President and Chief Executive Officer

Exhibit 99.1

Catalyst Biosciences Corporate Presentation 20 March 2023

2 © Catalyst Biosciences Cautionary Note Regarding Forward-Looking Statements This presentation contains “forward-looking statements” within the meaning of the federal securities laws, which statements involve substantial risks and uncertainties and are based on estimates and assumptions. Other than statements of historical facts, all statements included in this presentation are forward-looking statements, including, without limitation, the amount and timing of planned cash distributions under the contingent value rights agreement the (“CVR”); expectations regarding the proposed transactions with entities affiliated with GNI Group Ltd., including Beijing Continent Pharmaceuticals Co. Ltd. (“Beijing Continent”), the expected benefits and timing of the closing of the proposed transaction; the potential market opportunity for and expected development of Hydronidone (F351) in nonalcoholic steatohepatitis (“NASH”) and liver fibrosis; the safety and tolerability profile of Hydronidone (F351); the association of clinical data with potential clinical benefit; and statements regarding the potential of, and expectations regarding, Beijing Continent’s programs. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “design,” “expect,” “potential,” “plan,” or the negative of these terms, and similar expressions intended to identify forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially, including, but not limited to, the risks that the proposed business combination with Beijing Continent will not be completed in a timely manner, if at all; the risk that the development of Hydronidone (F351) in NASH and liver fibrosis will not be successful or require more capital than anticipated; the risk that results from the Phase 2 trial of Hydronidone (F351) in hepatitis related fibrosis will not be replicated in subsequent trials, and other risks described in the "Risk Factors" section of the Company's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) as well as the proxy statement and registration statement on Form S-3 to be filed with the SEC by Catalyst. We disclaim any obligation to update any forward-looking statements, except as required by law.

Generate further value for stockholders 3 CBIO corporate strategy December 2022 Acquired global rights (excluding China) to Hydronidone (F351), a drug designed to treat NASH and liver fibrosis Plan to acquire a controlling interest in Beijing Continent, a commercial biopharmaceutical company based in China, from the GNI Group Ltd. and related parties Announced $7.5 million special dividend and CVR 2023 Completed $6 million asset sale of compounds designed to treat rare bleeding disorders to GC Biopharma, with net proceeds to be distributed to CVR holders Annual Meeting of Stockholders expected to be held mid-2023 © Catalyst Biosciences

Transition Our Focus to Organ Fibrosis 4 CBIO 2023 corporate strategy Expect to consummate Beijing Continent business combination in mid-2023 Planning development of Hydronidone (F351) for NASH in the United States Beijing Continent expected to complete enrollment of Phase 3 trial in Hydronidone (F351) for hepatitis B virus (“HBV”)-associated liver fibrosis in China Distribute remaining net cash from legacy assets to CVR holders © Catalyst Biosciences

Consistent growth in revenue & profit 5 Beijing Continent sales of ETUARY (Pirfenidone) in China © Catalyst Biosciences © 2023 GNI Group Ltd. All rights reserved Beijing Continent Financials (Legal entity, local currency) P/L 000s RMB FY2020 FY2021 FY2022 20 vs 21 21 vs 22 Revenue 447,002 571,038 688,630 28% 21% COGS 26,627 25,629 29,299 -4% 14% Gross profit 420,375 545,409 659,331 30% 21% SG&A 228,460 314,799 413,936* 38% 31% R&D 37,212 46,188 53,768 24% 16% Profit before tax 156,656 188,704 194,193 20% 3% Profit after tax 127,927 149,387 151,594 17% 1% Headcount 419 481 523 15% 9% *including writing down of BC’s one-time listing expenses of JPY 395M

7 Hydronidone’s metabolic profile vs Pirfenidone improves safety © Catalyst Biosciences Pirfenidone Hydronidone – F351 Low potential of Hydronidone and its major metabolites for DDIs in terms of involvement of P-gp, CYP450, and major transporter systems In contrast to Pirfenidone, the shift toward Phase II metabolism may protect Hydronidone from formation of reactive metabolites and covalent protein binding, thus reducing its potential for idiosyncratic liver toxicity (Zhou S et al, J Med Chem 2020)

Has shown anti-fibrotic effects across standard models of liver fibrosis, including NASH More potent than Pirfenidone Pleiotropic mechanism of action designed to target the key drivers of fibrogenesis Independent of initial causative insult Results in inhibition of hematopoietic stem cell proliferation with potential to reverse liver fibrosis Absorption, distribution, metabolism and excretion profile is characterized by good oral bioavailability, exposure and metabolite profile relevant to humans, indicative of low DDI potential No adverse effects on major organ systems observed Well tolerated upon long-term dosing across species at exposures relevant to humans without major organ toxicity No genotoxicity or adverse effects on fertility and reproduction observed © Catalyst Biosciences Therapeutic effect & favorable safety profile in liver fibrosis 8 Hydronidone’s (F351) positive nonclinical risk/benefit profile

9 © Catalyst Biosciences Double blind, randomized, placebo-controlled + standard antiviral therapy* Phase 2 trial results in HBV-induced liver fibrosis Design A randomized, double-blind, placebo-controlled, multicenter, entecavir-based, dose-exploration phase 2 trial of Hydronidone (F351) capsules for the treatment of liver fibrosis associated with HBV (conducted in China by Beijing Continent) Basic Treatment *Entecavir administered continuously for 52 weeks Primary Endpoint Proportion of liver fibrosis Ishak scores decreased by ≥1 from baseline after 52 weeks of treatment Secondary Endpoint Conversion rate and decrease of HBV DNA after treatment Proportion of decrease in liver transient elastography values after treatment compared to pre-treatment Proportion of liver tissue inflammation grading decreased ≥ grade 1 after treatment compared to pre-treatment without worsening fibrosis Improvement of liver function alanine aminotransferase index Cai et al Clinical Gastroenterology & Hepatology 2022

10 © Catalyst Biosciences Double blind, randomized, placebo-controlled + entecavir Phase 2 trial results in HBV-induced liver fibrosis Enrolled (n=167) Hydronidone 180 mg (n=42) Hydronidone 270 mg (n=41) Hydronidone 360 mg (n=41) Placebo (n=43) Cai et al Clinical Gastroenterology & Hepatology 2022

11 © Catalyst Biosciences Primary Endpoint： The proportion of Ishak of liver fibrosis decreased by ≥1 point (fibrosis regression) from baseline after 52 weeks treatment Positive safety profile. There was no statistical difference in the occurrence of adverse events, adverse reactions and serious adverse events between the four groups during the trial Therapeutic Effect Safety Profile P = 0.0245 Phase 2 trial results in HBV-induced liver fibrosis Double blind, randomized, placebo-controlled + entecavir Cai et al Clinical Gastroenterology & Hepatology 2022

Potential treatment of liver fibrosis of different etiologies, including NASH 12 Clinical risk/benefit profile of Hydronidone (F351) is positive Positive results in a subpopulation of patients with significant liver fibrosis supports Hydronidone’s (F351) potential in preventing progression of liver fibrosis into cirrhosis No statistical difference in the occurrence of adverse events, adverse drug reactions, or serious adverse events between the four groups during the Phase 2 trial Good safety profile demonstrated in subjects with mild hepatic impairment No adverse effects nor prolongation of QT interval Food consumption slows down absorption of Hydronidone (F351) and its major metabolites and reduces the Cmax values; therefore, dosing on an empty stomach is recommended No clinically relevant DDIs observed © Catalyst Biosciences

Transitioning Our Focus to Organ Fibrosis 13 CBIO Summary Acquired global rights (excluding China) to Hydronidone (F351), a drug designed to treat NASH and liver fibrosis and demonstrating promising efficacy and safety results Anticipate completing a business combination with Beijing Continent, a commercial-stage biopharmaceutical company based in China in mid-2023 Hydronidone (F351) clinical readouts expected in 2024 for HBV-associated fibrosis and NASH Planned additional cash distributions to CVR holders in 2023 and 2025 © Catalyst Biosciences