INVA Innoviva Inc

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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): November 6, 2023

 

INNOVIVA, INC.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware	000-30319	94-3265960
(State or Other Jurisdiction of Incorporation)	(Commission  File Number)	(I.R.S. Employer Identification Number)

 

1350 Old Bayshore Highway,
Suite 400

Burlingame, California 94010

(650) 238-9600

(Addresses, including zip code, and telephone numbers, including area code, of principal executive offices) 

 

(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, par value $0.01 per share		INVA		The NASDAQ Global Select 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 November 6, 2023, Innoviva, Inc. (the “Company”) made available on its website a presentation discussing topline data from the Phase 3 clinical trial of Zoliflodacin (the “Zoliflodacin Clinical Data Presentation”). A copy of the Zoliflodacin Clinical Data Presentation is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

 

The information included in this Current Report on Form 8-K that is furnished pursuant to this Item 7.01, including the information contained in Exhibit 99.1 hereto, shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. In addition, the information included in this Current Report on Form 8-K that is furnished pursuant to this Item 7.01, including the information contained in Exhibit 99.1 hereto, shall not be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference into such filing.

 

Item 9.01. Financial Statements and Exhibits

 

(d) Exhibits

 

99.1		Zoliflodacin Clinical Data Presentation, dated November 6, 2023
104		Cover Page Interactive File (the cover page tags are embedded within the Inline XBRL document)

 

 

SIGNATURE

 

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

 

INNOVIVA, INC.

 

Date: November 6, 2023	By:	/s/ Pavel Raifeld
		Pavel Raifeld
		Chief Executive Officer

 

 

 

Exhibit 99.1

 

Zoliflodacin Phase 3 clinical trial topline data November 2, 2023

Top line summary: positive zoliflodacin Phase 3 results 1 – WHO global antimicrobial resistance suveillance. Lancet Microbe 2021; 2: e627 – 36 2 – Lancet 2023; 9: e332 - 33 2 • An estimated 82 million patients contract gonorrhea each year 1 , with rising rates of resistance to standard of care regimens in many countries 2 . • We ran a global pivotal phase 3 trial to evaluate the efficacy of a single 3g oral dose of zoliflodacin in treatment of uncomplicated gonorrhea compared to treatment with a combination of intramuscular injection of ceftriaxone and oral azithromycin. • Zoliflodacin met the primary efficacy endpoint and was non - inferior to the comparator arm in participants with urogenital disease (point estimate 5.3% (95% confidence interval: 1.4%, 8.7%)). • For the key secondary analyses of infections at rectal and pharyngeal sites, rates of cure in the zoliflodacin arm were comparable to those observed in the comparator arm, though these analyses were not powered for statistical significance. • In this study, zoliflodacin was safe and generally well - tolerated; majority of adverse events were mild to moderate with no discontinuations due to adverse events, serious adverse events, or deaths. • The study outcome could provide an important therapeutic option for patients and is a positive milestone in the development of zoliflodacin and the fight against antimicrobial resistance.

Zoliflodacin Phase 3 registration study design 3 The zoliflodacin pivotal Phase 3 registration trial was conducted to evaluate the efficacy of a single 3g oral dose of zoliflodacin in treatment of uncomplicated gonorrhea compared to treatment with intramuscular injection of ceftriaxone and oral azithromycin, a current global standard of care regimen. The primary efficacy endpoint was microbiological test of cure at urethral or cervical sites (urogenital) in participants who had a positive culture for gonorrhea at baseline. Secondary analyses were microbiological cure at rectal or pharyngeal sites and safety. The trial was designed with a 90% power and a 10% noninferiority margin. This was a global study, conducted at 16 sites in the United States, South Africa, Belgium, Netherlands, and Thailand. Patients with confirmed uncomplicated gonorrhea Primary efficacy analysis: Microbiological cure at urethral or cervical sites (urogenital) at TOC (day 6 “ 2) Patients with documented or presumed uncomplicated gonorrhea 2:1 Secondary analyses: Microbiological cure at rectal or pharyngeal sites at TOC (day 6 “ 2); safety Oral dose zoliflodacin (3g) Ceftriaxone IM injection (500mg) + oral azithromycin (1g) Abbreviations: CRO - AZI – ceftriaxone and azithromycin; IM – intramuscular injection

Study enrollment 4 1011 patients were initially screened, with 927 randomized and dosed. The majority of participants (744) presented with urogenital infections, followed by rectal infections (114) and pharyngeal infections (81). Participants could be in more than one group. Overall, the trial participants were 87% male, 1 3% female, 55% Black or Black African, and 20% were positive for human immunodeficiency virus (HIV). Participants in a key secondary analysis Participants analyzed for primary endpoint Screened n = 1011 Pharyngeal n = 81 Rectal n = 114 Urogenital n = 744 Participants in a key secondary analysis Randomized n = 930 Randomized & dosed n = 927 Zoliflodacin n = 619 CRO - AZI n = 308 506: zoliflodacin 238: CRO - AZI 79: zoliflodacin 35: CRO - AZI 53: zoliflodacin 28: CRO - AZI Sites of infection (participants could be in more than one group) Enrollment and dosing Abbreviations: CRO - AZI – ceftriaxone and azithromycin

The primary endpoint was achieved A high microbiological cure rate (>90% in both arms) was observed 5 Microbiological cure rate at test of cure visit Zoliflodacin met the primary efficacy endpoint and was non - inferior to the comparator (point estimate 5.3% (95% confidence interval (CI): 1.4%, 8.7%)). The intent to treat analysis included all participants with a positive baseline culture for gonorrhea; those who missed the test of cure culture, were out of window, or had demonstrated microbiologic failure, were recorded as failures. When participants who had both baseline and follow up cultures were evaluated, the point estimate was reduced to 3.2% (95% CI, 1.1%, 5.1%). Clinical cure rates, as assessed by improvement in symptoms in the subset of male participants with urogenital disease, were also comparable between zoliflodacin and the comparator arms 90.9% 96.8% 96.2% 100.0% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Micro-ITT population Evaluable population Zoliflodacin Ceftriaxone + azithromycin 5.3% difference 95% CI: 1.4%, 8.7% 3.2% difference 95% CI: 1.1%, 5.1%

Key secondary analyses showed comparable results in comparison to ceftriaxone and azithromycin 6 Microbiological cure rate at test of cure visit Key secondary analysis included participants with pharyngeal and rectal gonorrhea. Historical rates of cure for these populations have been lower than those observed in urogenital disease. Rates of cure in the zoliflodacin arm were comparable to those observed in the comparator arm. These secondary analyses were not powered for statistical significance. 79.2% 87.3% 78.6% 88.6% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Pharyngeal infections Rectal infections Zoliflodacin Ceftriaxone + azithromycin - 0.7% difference 95% CI: - 20.8%, 16.3% 1.2% difference 95% CI: - 14.4%, 12.6%

Favorable safety and tolerability profile in this study 7 In this study, zoliflodacin was safe and generally well - tolerated The overall rate of adverse events was comparable between the two arms The majority of adverse events were mild to moderate There were no discontinuations reported due to adverse events, serious adverse events, or deaths Zoliflodacin N=619 n (%) CRO - AZI N=308 n (%) All TEAEs 286 (46.2) 143 (46.4) Drug - related TEAEs 117 (18.9) 76 (24.7) SAEs 0 0 Drug - related SAEs 0 0 Withdrawals due to adverse events 0 0 TEAEs leading to death 0 0 TEAE Zoliflodacin CRO - AZI Headache 61 (9.9) 14 (4.5) Neutropenia 42 (6.8) 24 (7.8) Leukopenia 24 (3.9) 7 (2.3) Neutrophil count decreased 21 (3.4) 15 (4.9) Dizziness 21 (3.4) 5 (1.6) Nausea 16 (2.6) 12 (3.9) Diarrhea 15 (2.4) 22 (7.1) Abbreviations: TEAE – Treatment emergent adverse event; SAE – Serious adverse event; CRO - AZI – ceftriaxone and azithromycin

 

v3.23.3

Cover	Nov. 06, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 06, 2023
Entity File Number	000-30319
Entity Registrant Name	INNOVIVA, INC.
Entity Central Index Key	0001080014
Entity Tax Identification Number	94-3265960
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	1350 Old Bayshore Highway
Entity Address, Address Line Two	Suite 400
Entity Address, City or Town	Burlingame
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94010
City Area Code	650
Local Phone Number	238-9600
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.01 per share
Trading Symbol	INVA
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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