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PrairieSky Royalty Declares Quarterly Dividend

CALGARY, Alberta, Dec. 07, 2020 (GLOBE NEWSWIRE) — PrairieSky Royalty Ltd. (“PrairieSky”) (TSX:PSK) announced today that its Board of Directors has declared a quarterly dividend of CDN $0.06 per common share, payable in cash on January 15, 2021 to shareholders of record on December 31, 2020.   This dividend is designated as an “eligible dividend” for Canadian income tax purposes.

About PrairieSky Royalty Ltd.

PrairieSky is a royalty-focused company, generating royalty revenues as petroleum and natural gas are produced from its properties. PrairieSky has a diverse portfolio of properties that have a long history of generating free cash flow and that represent the largest and most concentrated independently-owned fee simple mineral title position in Canada. PrairieSky common shares trade on the Toronto Stock Exchange under the symbol PSK.

FOR FURTHER INFORMATION PLEASE CONTACT:

PrairieSky Royalty Ltd.
 
Investor Relations
(587) 293-4000
 
www.prairiesky.com

PDF available: http://ml.globenewswire.com/Resource/Download/847b5349-71f5-4f0c-b0e0-6e700988d2c2



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iBio Announces Proposed Public Offering of Common Stock

BRYAN, Texas, Dec. 07, 2020 (GLOBE NEWSWIRE) — iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), a biotech innovator and biologics contract manufacturing organization, today announced an underwritten public offering of its common stock. In addition, iBio has granted the underwriter a 30-day option to purchase up to an additional 15% of the number of shares of its common stock offered in the public offering.

Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering.

iBio anticipates using the net proceeds from the offering to accelerate development of its biotherapeutic and vaccine candidates, in-licensing of biopharmaceutical assets, including, but not limited to, those in oncology, fibrotic, and infectious diseases, and working capital needs and for other general corporate purposes, including acquisitions and investments in other businesses.

The securities described above are being offered by iBio pursuant to a shelf registration statement on Form S-3 previously filed with, and declared effective by, the Securities and Exchange Commission (the “SEC”). A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying base prospectus relating to this offering may be obtained, when available, from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About iBio, Inc.

iBio is a global leader in plant-based biologics manufacturing. Its FastPharming® System combines vertical farming, automated hydroponics, and glycan engineering technologies to rapidly deliver high-quality monoclonal antibodies, vaccines, bioinks and other proteins. iBio is developing proprietary products on the FastPharming Platform, which include biopharmaceuticals for the treatment of fibrotic and infectious diseases, amongst others. The Company’s subsidiary, iBio CDMO LLC, provides FastPharming Contract Development and Manufacturing Services along with the Glycaneering Development Service™ for engineering high-performance recombinant glycoproteins.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding completion of the offering and the anticipated use of proceeds. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, changes to the offering as a result of market conditions or for other reasons, the risk that the offering will not be consummated, the Company’s ability to obtain regulatory approvals for commercialization of its product candidates, including its infectious disease vaccines, or to comply with ongoing regulatory requirements, regulatory limitations relating to its ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, its ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, competition, its ability to retain its key employees or maintain its NYSE American listing, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended June 30, 2020 and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Form 10-Q and Form 8-K. The information in this release is provided only as of the date of this release, and we undertake no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

Contact:

Stephen Kilmer
iBio, Inc.
Investor Relations
(646) 274-3580
[email protected]



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Kura Oncology Announces Commencement of Public Offering of Common Stock

SAN DIEGO, Dec. 07, 2020 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell $200,000,000 of shares of its common stock. In connection with the offering, Kura expects to grant the underwriters a 30-day option to purchase up to an additional $30,000,000 of the shares of common stock offered in the public offering. All of the shares in the proposed offering will be offered by Kura. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

SVB Leerink, Credit Suisse, Barclays and Stifel are acting as joint bookrunning managers in the offering.

The securities described above are being offered by Kura pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Kura with and became effective by rule of the Securities and Exchange Commission (the “SEC”) on December 7, 2020. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at http://www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected]; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected], or by telephone at (888) 603-5847; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by email at [email protected], or by telephone at (415) 364-2720.

This press release shall not constitute an offer to sell or the 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.

About Kura Oncology

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of two wholly owned small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura’s most advanced drug candidate is tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor currently in a registration-directed trial (AIM-HN) in patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma. The Company’s pipeline is also highlighted by KO-539, a potent and selective menin inhibitor currently in a Phase 1/2A clinical trial (KOMET-001) in patients with relapsed or refractory acute myeloid leukemia.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements about Kura’s expectations regarding the completion and timing of the proposed offering, and its expectations with respect to granting the underwriters a 30-day option to purchase additional shares. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Kura’s current expectations and involve assumptions that may never materialize or may prove to be incorrect.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with market conditions and the satisfaction of closing conditions related to the proposed public offering, risks and uncertainties associated with Kura’s business and finances in general, risks associated with the COVID-19 global pandemic, and the other risks described in Kura’s quarterly report on Form 10-Q for the quarterly period ended September 30, 2020, the preliminary prospectus supplement relating to the proposed public offering and other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Kura undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contacts

Company:
Pete De Spain
Vice President, Investor Relations &
Corporate Communications
(858) 500-8803
[email protected]

Investors:
Robert H. Uhl
Managing Director
Westwicke Partners, LLC
(858) 356-5932
[email protected]

Media:
Jason Spark
Managing Director
Canale Communications
(619) 849-6005
[email protected]



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Sutro Biopharma Announces Proposed Public Offering of 5 Million Shares of Common Stock

PR Newswire

SOUTH SAN FRANCISCO, Calif., Dec. 7, 2020 /PRNewswire/ — Sutro Biopharma, Inc. (Nasdaq: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, today announced a proposed underwritten public offering in which it intends to offer and sell 5,000,000 shares of its common stock. In addition, Sutro intends to grant the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock offered in the public offering. All of the shares of common stock are being offered by Sutro. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Cowen, Piper Sandler and Wells Fargo Securities are acting as joint book-running managers in the offering. Wedbush PacGrow and JMP Securities are acting as co-managers for the offering.

Sutro intends to use the net proceeds from the proposed offering, together with its existing cash, cash equivalents and marketable securities, to fund the continued clinical development of STRO-001 and STRO-002 and the remainder to fund the further development of its technology platform, including manufacturing, to broaden its pipeline of product candidates, and for working capital and general corporate purposes.

The shares are being offered by Sutro pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924, or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York 10001, by telephone at (800) 326-5897, or by email at [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at http://www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Sutro, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Sutro Biopharma

Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.

Sutro’s proprietary and integrated cell-free protein synthesis platform XpressCF® and site-specific conjugation platform XpressCF+™ led to the discovery of STRO-001 and STRO-002, Sutro’s first two internally-developed ADCs. STRO-001 is a CD74-targeting ADC currently being investigated in a Phase 1 clinical trial of patients with advanced B-cell malignancies, including multiple myeloma and non-Hodgkin lymphoma. STRO-001 was granted Orphan Drug Designation by the FDA for multiple myeloma in October 2018. STRO-002 is a folate receptor alpha (FolRα)-targeting ADC, currently being investigated in a Phase 1 clinical trial of patients with ovarian and endometrial cancers. This is the second product candidate to be evaluated in clinical trials resulting from Sutro’s XpressCF® and XpressCF+™ technology platforms. A third program, CC-99712 (BCMA-targeting ADC), which is part of Sutro’s collaboration with Bristol Myers Squibb (formerly Celgene Corporation), is enrolling patients for its Phase 1 clinical trial of patients with multiple myeloma. Sutro’s proprietary technology was responsible for the discovery and manufacturing of CC-99712, for which Bristol Myers Squibb has worldwide development and commercialization rights. Sutro is entitled to development and regulatory milestone payments and tiered royalties from Bristol Myers Squibb for this BCMA ADC. Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need.

To date, Sutro’s platform has led to cytokine-based immuno-oncology therapies, ADCs, vaccines and bispecific antibodies directed at precedented targets in clinical indications where the current standard of care is suboptimal. The platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.

In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements the Company makes regarding its intention to conduct an offering and sale of securities, the grant of the option to purchase additional shares, the  ability to complete the offering and expected use of proceeds and anticipated preclinical and clinical development activities, timing of clinical trials and announcements of clinical results, potential benefits of the Company’s product candidates and platform and potential market opportunities for the Company’s product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the Company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the Company’s intention to conduct an offering and sale of securities, the grant of the option to purchase additional shares, the  ability to complete the offering and expected use of proceeds and the Company’s ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, the impact of the COVID-19 pandemic on the Company’s business, clinical trial sites, supply chain and manufacturing facilities, the Company’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the Company’s ability to protect intellectual property, and the Company’s commercial collaborations with third parties and other risks and uncertainties described under the heading “Risk Factors” in documents the Company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

Investor Contact
Annie J. Chang 
Sutro Biopharma 
+1 650-255-8806  
[email protected] 

Media Contacts

David Schull

Russo Partners
(212) 845-4271
[email protected]

Cision View original content:http://www.prnewswire.com/news-releases/sutro-biopharma-announces-proposed-public-offering-of-5-million-shares-of-common-stock-301187672.html

SOURCE Sutro Biopharma

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Nektar Therapeutics Announces Presentation of Preclinical Data for NKTR-255, its Novel IL-15 Agonist, at the American Society of Hematology (ASH) 2020 Annual Meeting

PR Newswire

SAN FRANCISCO, Dec. 7, 2020 /PRNewswire/ — Nektar Therapeutics (NASDAQ: NKTR) today announced two nonclinical data presentations for NKTR-255, its IL-15 pathway agonist, at the 62nd American Society of Hematology (ASH) Annual Meeting. The presentations include an oral presentation of translational research studies conducted in collaboration with researchers from Dana-Farber Cancer Center. 

NKTR-255 is an interleukin-15 (IL-15) receptor agonist that is designed to expand both natural killer (NK) cells and memory CD8 T cell populations. It is currently being evaluated in multiple clinical studies in both hematological and solid tumors in combination with agents that induce antibody-dependent cellular toxicity (ADCC). In the hematological setting, NKTR-255 is being tested in a Phase 1b/2 clinical study as monotherapy and in combination with rituximab or daratumumab in patients with multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL). It is also being evaluated in a Phase 1b/2 solid tumor trial in combination with cetuximab for the treatment of colorectal cancer and head and neck squamous cell carcinoma (HNSCC).

“Inhibition of NK cell effector functions is a mechanism for immune evasion in patients with multiple myeloma and therefore restoring and enhancing NK cell functionality is a key goal for new immunotherapeutic approaches, ” said Nikhil C. Munshi, MD, Professor of Medicine at Harvard Medical School, Director of Basic and Correlative Science, and Associate Director of the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute. “In our studies, we found the novel IL-15 receptor agonist, NKTR-255, was effective in reverting the inhibitory status observed in NK cells from MM patients, leading to enhanced direct NK cytotoxicity against several MM cell lines and primary MM cells. In addition, we saw a significant increase in ADCC activity in vitro with NKTR-255 in combination with myeloma-targeting antibodies as compared to activity with those antibodies alone. These data accentuate the potential for NKTR-255 as an innovative immunotherapeutic agent in the treatment of multiple myeloma.”

“The ASH presentations add to the growing body of data for NKTR-255 that highlight its ability to enhance NK cell effector function and greatly potentiate the ADCC mechanisms of targeted antibodies,” said Jonathan Zalevsky, Ph.D., Chief Research & Development Officer at Nektar. “We are excited about the development potential of NKTR-255, especially as we’ve already observed biological activity in the first multiple myeloma and non-Hodgkin’s lymphoma patients treated in the monotherapy dose-escalation phase of our liquid tumor study.”

Details of the preclinical data presentations at ASH are listed below and are available on the scientific section of Nektar’s website at http://www.nektar.com/science/scientific-posters-and-presentations:

Abstract 667: “Restoring NK Cell Activities in Multiple Myeloma with IL-15 Receptor Agonist NKTR-255,” Fernández, R. A., et al. (This study was conducted in collaboration with Dr. Nikhil C. Munshi at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute.)

  • Oral Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy
  • Date:
    Monday, December 7, 2020, 2:30 p.m. Eastern Standard Time
    • The induction of an activated profile in NK cells by NKTR-255 results in an effective enhancement of their anti-myeloma effector function in ex vivo assays.
    • In vivo studies confirmed superiority of the combination of daratumumab and NKTR-255 compared to single agents in controlling MM growth.
    • NKTR-255 improves the immune cell compartment both in the tumor tissue and blood following anti-CD38 treatment.

Abstract 825: “Optimizing Ex-Vivo Expanded NK Cell- Mediated Antibody-Dependent Cellular Cytotoxicity (ADCC) Combined with NKTR-255 in Chronic Lymphocytic Leukemia (CLL), Follicular Lymphoma (FL), and Burkitt Lymphoma (BL),” Chu, Y., et al. (This study was conducted in collaboration with Dr. Mitchell Cairo at New York Medical College.)

  • Poster Session: 203. Lymphocytes, Lymphocyte Activation, and Immunodeficiency, including HIV and Other Infections: Poster I
  • Date:
    Saturday, December 5, 2020, 7:00 a.m. – 3:30 p.m. Eastern Standard Time
    • NKTR-255 significantly enhanced the in vitro cytotoxicity of expanded NK cells when combined with rituximab against MEC-1, PGA-1, and DOHH2 as compared to the control groups.
    • NKTR-255 also significantly enhanced the in vitro cytotoxicity of expanded NK cells when combined with obinutuzumab against rituximab-resistant BL cells like Raji-2R and Raji-4RH as compared to the control groups.
    • NKTR-255 significantly enhanced the ADCC of expanded NK cells with anti-CD20 type I and type II antibodies against CLL, FL and rituximab-resistant BL cells in vitro with enhanced IFN-γ, granzyme B and perforin release.

About NKTR-255

NKTR-255 is an IL-15 receptor agonist designed to activate the IL-15 pathway and expand NK cells and promote the survival and expansion of memory CD8+ T cells without inducing suppressive regulatory T cells. Through optimal engagement of the IL-15Rα/IL-2Rβγ receptor complex, NKTR-255 enhances functional NK cell population and formation of long-term immunological memory, which may lead to sustained anti-tumor immune response. NKTR-255 is uniquely designed to overcome the challenges of recombinant IL-15 and other IL-15 agonists, which are rapidly cleared from the body and have shown diminishing response to successive doses.1 NKTR-255 was designed using Nektar’s polymer conjugation technology to extend circulating half-life.

About Nektar

Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology, immunology, and virology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements which can be identified by words such as: “potential,” “design,” “enhance,” “may,” “test,” “evaluate” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the expected benefits of NKTR-255 (both alone as a single agent as well as in combination with other agents, such as targeted antibodies), the ability to obtain useful data from the Phase 1b/2 clinical study of NKTR-255, and the future clinical development plans for NKTR-255. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) NKTR-255 is in early-stage clinical development and there are substantial risks that can unexpectedly occur for numerous reasons including negative safety and efficacy findings in the Phase 1b/2 clinical study notwithstanding positive preclinical findings; (ii) clinical study outcomes, including the Phase 1b/2 clinical study outcome of NKTR-255, remain very unpredictable and it is possible that a clinical study could fail due to efficacy, safety or other important clinical findings; (iii) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, and competitive factors; (iv) scientific discovery of new therapeutics is an inherently uncertain process and the future success of applying our technology platform to potential new drug candidates (such as NKTR-255) is therefore highly uncertain and unpredictable; (v) patents may not issue from our patent applications for NKTR-255, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vi) certain other important risks and uncertainties set forth in Nektar’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 6, 2020. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contact:

For Investors:

Jerry Isaacson of Nektar Therapeutics
628-895-0634
Vivian Wu of Nektar Therapeutics
628-895-0661

For Media:

Dan Budwick of 1AB
973-271-6085
[email protected]

1.  Blood 2018 Jun 7;131(23):2515-2527

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SOURCE Nektar Therapeutics

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INVESTOR ALERT: Law Offices of Howard G. Smith Announces Investigation of Boston Scientific Corporation (BSX) on Behalf of Investors

INVESTOR ALERT: Law Offices of Howard G. Smith Announces Investigation of Boston Scientific Corporation (BSX) on Behalf of Investors

BENSALEM, Pa.–(BUSINESS WIRE)–
Law Offices of Howard G. Smith announces an investigation on behalf of Boston Scientific Corporation (“Boston Scientific” or the “Company”) (NYSE: BSX) investors concerning the Company’s possible violations of federal securities laws.

On November 17, 2020, Boston Scientific announced a worldwide recall of all unused inventory of the LOTUS Edge Aortic Valve System, a transcatheter aortic valve replacement product which had been approved by the U.S. Food and Drug Administration (“FDA”) in April 2019. Citing “complexities associated with the product delivery system” and the “additional time and investment required to develop and reintroduce an enhanced delivery system,” the Company stated that it had “chosen to retire the entire LOTUS product platform immediately.”

On this news, Boston Scientific’s stock price fell $3.00 per share, or approximately 8%, to close at $35.03 per share on November 17, 2020, thereby injuring investors.

If you purchased Boston Scientific securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to [email protected], or visit our website at www.howardsmithlaw.com.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Law Offices of Howard G. Smith

Howard G. Smith, Esquire

215-638-4847

888-638-4847

[email protected]

www.howardsmithlaw.com

KEYWORDS: California Pennsylvania United States North America

INDUSTRY KEYWORDS: Legal Professional Services

MEDIA:

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Intuit Updates Full Fiscal Year and Second Quarter Outlook Reflecting the Close of the Credit Karma Acquisition

Intuit Updates Full Fiscal Year and Second Quarter Outlook Reflecting the Close of the Credit Karma Acquisition

MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–
Intuit Inc. (Nasdaq: INTU), maker of TurboTax, QuickBooks and Mint, today updated its full fiscal year 2021 and second fiscal quarter guidance to reflect the close of the Credit Karma acquisition on Dec. 3. The completion of the acquisition allows Intuit and Credit Karma to begin to transform personal finance by making it simpler for consumers to find the right financial products, put more money in their pockets, and access financial expertise and advice.

For the full fiscal year 2021, the company expects:

  • Revenue of $8.810 billion to $8.995 billion, growth of approximately 15 to 17 percent.
  • GAAP operating income of $1.920 billion to $1.990 billion, a decline of approximately 9 to 12 percent.
  • Non-GAAP operating income of $2.975 billion to $3.045 billion, growth of approximately 12 to 14 percent.
  • GAAP diluted earnings per share of $5.30 to $5.50, a decline of approximately 21 to 23 percent.
  • Non-GAAP diluted earnings per share of $8.20 to $8.40, growth of approximately 4 to 7 percent.

This fiscal 2021 guidance includes Credit Karma beginning Dec. 3. The company expects Credit Karma revenue of $545 million to $580 million and segment operating income of $15 million to $35 million in fiscal 2021. Fiscal 2021 GAAP operating income for Intuit includes $343 million for stock-based compensation expense and $174 million for amortization expense associated with the acquisition of Credit Karma.

The company updated segment revenue guidance to include Credit Karma for fiscal year 2021:

  • Small Business and Self-Employed Group: growth of approximately 8 to 10 percent.
  • Consumer Group: growth of approximately 9 to 10 percent.
  • ProConnect Group: growth approximately of 0 to 1 percent.
  • Credit Karma: revenue of $545 million to $580 million.

For the second quarter of fiscal year 2021, which ends Jan. 31, the company expects:

  • Revenue of $1.935 billion to $1.965 billion, growth of approximately 14 to 16 percent.
  • GAAP operating income of $171 million to $191 million.
  • Non-GAAP operating income of $455 million to $475 million.
  • GAAP diluted earnings per share of $0.43 to $0.49.
  • Non-GAAP diluted earnings per share of $1.25 to $1.31.

This second quarter guidance includes Credit Karma beginning Dec. 3.

Intuit plans to operate Credit Karma as a separate reporting segment, and segment operating income includes all direct expenses. Therefore, Credit Karma segment operating income is not comparable to those of Intuit’s other reporting segments. Share-based compensation expense and amortization of acquired technology and other intangible assets related to the Credit Karma acquisition are included in unallocated corporate expenses. For other segments, expenses such as corporate selling and marketing, product development, general and administrative and share-based compensation are not allocated to specific segments and are included in unallocated corporate expenses. In addition, amortization of acquired technology, amortization of other acquired intangible assets, and goodwill and intangible asset impairment charges are also included in unallocated corporate expenses.

Guidance Update Conference Call Details

Intuit executives will host a conference call to discuss updated guidance to include Credit Karma for the second quarter and full year of fiscal 2021 at 1:30 p.m. Pacific time on December 7. To participate in the call, dial 866-417-5279 in the United States or 409-937-8904 from international locations. No reservation or access code is needed. The conference call can also be heard live at http://investors.intuit.com/Events/default.aspx. Prepared remarks for the call will be available on Intuit’s website after the call ends.

Replay Information

A replay of this conference call will be available for one week by calling 855-859-2056, or 404-537-3406 from international locations. The access code for this call is 1335808. The audio webcast will remain available on Intuit’s website for one week after the conference call.

About Intuit

Intuit’s mission is to power prosperity around the world. We are a mission-driven, global financial platform company with products including TurboTax, QuickBooks, and Mint, designed to empower consumers, self-employed and small businesses to improve their financial lives. Our platform and products help customers get more money with the least amount of work, while giving them complete confidence in their actions and decisions. Our innovative ecosystem of financial management solutions serves more than 50 million customers worldwide. Please visit us for the latest news and in-depth information about Intuit and its brands and find us on social.

About Non-GAAP Financial Measures

This press release and the accompanying table include non-GAAP financial measures. For a description of these non-GAAP financial measures, including the reasons management uses each measure, and reconciliations of these non-GAAP financial measures to the most directly comparable financial measures prepared in accordance with Generally Accepted Accounting Principles, please see the section of the accompanying table titled “About Non-GAAP Financial Measures”. A copy of the press release issued by Intuit today can be found on the investor relations page of Intuit’s website.

Cautions About Forward-looking Statements

This press release contain forward-looking statements within the meaning of applicable securities laws, including forecasts of expected growth and future financial results of Intuit and its reporting segments, including Credit Karma; Intuit’s prospects for the business in fiscal 2021 and beyond; expectations regarding timing and growth of revenue for each of Intuit’s reporting segments; expectations regarding the impact of our strategic decisions on Intuit’s business; expectations regarding the impact of the Credit Karma acquisition; and all of the statements relating to second fiscal quarter and full fiscal year 2021 guidance. Forward-looking statements and information usually relate to future events and anticipated revenues, earnings, cash flows or other aspects of our operations or operating results. Forward-looking statements are often identified by the words “believe,” “expect,” “anticipate,” “plan,” “intend,” “foresee,” “should,” “would,” “could,” “may,” “will,” “estimate,” “outlook” and similar expressions, including the negative thereof. The absence of these words, however, does not mean that the statements are not forward-looking.

Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause our actual results to differ materially from the expectations expressed in the forward-looking statements. These risks and uncertainties may be amplified by the COVID-19 pandemic, which has caused significant global economic instability and uncertainty. Given these risks and uncertainties, persons reading this communication are cautioned not to place any undue reliance on such forward-looking statements. These factors include, without limitation, the following: our ability to compete successfully; our participation in the Free File Alliance; potential governmental encroachment in our tax businesses; our ability to adapt to technological change; our ability to predict consumer behavior; our reliance on third-party intellectual property; our ability to protect our intellectual property rights; any harm to our reputation; risks associated with acquisition and divestiture activity; the issuance of equity or incurrence of debt to fund an acquisition; our cybersecurity incidents (including those affecting the third parties we rely on); customer concerns about privacy and cybersecurity incidents; fraudulent activities by third parties using our offerings; our failure to process transactions effectively; interruption or failure of our information technology; our ability to maintain critical third-party business relationships; our ability to attract and retain talent; any deficiency in the quality or accuracy of our products (including the advice given by experts on our platform); any delays in product launches; difficulties in processing or filing customer tax submissions; risks associated with international operations; changes to public policy, laws or regulations affecting our businesses; litigation in which we are involved; the seasonal nature of our tax business; changes in tax rates and tax reform legislation; global economic changes; exposure to credit, counterparty or other risks in providing capital to businesses; amortization of acquired intangible assets and impairment charges; our ability to repay or otherwise comply with the terms of our outstanding debt; our ability to repurchase shares or distribute dividends; volatility of our stock price; our ability to successfully market our offerings; risks associated with tax liabilities or changes in U.S. federal tax laws or interpretations to which the transaction with Credit Karma or parties thereto are subject; failure to successfully integrate any new business, including Credit Karma; failure to realize anticipated benefits and synergies of combined operations with Credit Karma; unanticipated costs, expenses or difficulties of integrating Credit Karma; the risk that the conditions imposed in connection with the regulatory approval for the combined business, including the divestiture of the Credit Karma Tax business, could adversely affect us and/or the expected benefits of the combined business; potential impact of consummation of the acquisition on relationships with third parties, including employees, customers, partners and competitors; inability to retain key personnel; changes in legislation or government regulations affecting the acquisition or the parties; economic and/or political conditions that could adversely affect the parties; the impact of the COVID-19 pandemic; and risks associated with assumptions the parties make in connection with the parties’ critical accounting estimates and legal proceedings.

More details about these and other risks that may impact our business are included in our Form 10-K for fiscal 2020 and in our other SEC filings. You can locate these reports through our website at http://investors.intuit.com. Second quarter and full year fiscal 2021 guidance speaks only as of the date it was publicly issued by Intuit. Other forward-looking statements represent the judgment of the management of Intuit as of the date of this presentation. We do not undertake any duty to update any forward-looking statement or other information in this presentation.

 

TABLE 1

INTUIT INC.

RECONCILIATION OF FORWARD-LOOKING GUIDANCE FOR NON-GAAP FINANCIAL MEASURES TO PROJECTED GAAP REVENUE, OPERATING INCOME, AND EPS

(In millions, except per share amounts)

(Unaudited)

 

 

Forward-Looking Guidance

 

GAAP

Range of Estimate

 

 

 

Non-GAAP

Range of Estimate

 

From

 

To

 

Adjmts

 

From

 

To

Three Months Ending January 31, 2021

 

 

 

 

 

 

 

 

 

Revenue

$

1,935

 

 

$

1,965

 

 

$

—

 

 

$

1,935

 

 

$

1,965

 

Operating income

$

171

 

 

$

191

 

 

$

284

 

[a]

$

455

 

 

$

475

 

Diluted earnings per share

$

0.43

 

 

$

0.49

 

 

$

0.82

 

[b]

$

1.25

 

 

$

1.31

 

 

 

 

 

 

 

 

 

 

 

Twelve Months Ending July 31, 2021

 

 

 

 

 

 

 

 

 

Revenue

$

8,810

 

 

$

8,995

 

 

$

—

 

 

$

8,810

 

 

$

8,995

 

Operating income

$

1,920

 

 

$

1,990

 

 

$

1,055

 

[c]

$

2,975

 

 

$

3,045

 

Diluted earnings per share

$

5.30

 

 

$

5.50

 

 

$

2.90

 

[d]

$

8.20

 

 

$

8.40

 

 

See “About Non-GAAP Financial Measures” immediately following Table 1 for information on these measures, the items excluded from the most directly comparable GAAP measures in arriving at non-GAAP financial measures, and the reasons management uses each measure and excludes the specified amounts in arriving at each non-GAAP financial measure.

 

[a]

Reflects estimated adjustments for share-based compensation expense of approximately $198 million, which includes approximately $85 million related to Credit Karma; professional fees for business combinations of approximately $34 million; amortization of acquired technology of approximately $14 million, which includes approximately $7 million related to Credit Karma; and amortization of other acquired intangible assets of approximately $38 million, which includes $37 million related to Credit Karma.

 

[b]

Reflects estimated adjustments in item [a], income taxes related to these adjustments, and other income tax effects related to the use of the non-GAAP tax rate.

 

[c]

Reflects estimated adjustments for share-based compensation expense of approximately $813 million, which includes approximately $343 million related to Credit Karma; professional fees for business combinations of approximately $39 million; amortization of acquired technology of approximately $51 million, which includes approximately $27 million related to Credit Karma; and amortization of other acquired intangible assets of approximately $152 million, which includes $147 million related to Credit Karma.

 

[d]

Reflects estimated adjustments in item [c], income taxes related to these adjustments, and other income tax effects related to the use of the non-GAAP tax rate.

 

INTUIT INC.

ABOUT NON-GAAP FINANCIAL MEASURES

The accompanying press release dated December 7, 2020 contains non-GAAP financial measures. Table 1 reconciles the non-GAAP financial measures in that press release to the most directly comparable financial measures prepared in accordance with Generally Accepted Accounting Principles (GAAP). These non-GAAP financial measures include non-GAAP operating income (loss), non-GAAP net income (loss) and non-GAAP net income (loss) per share.

Non-GAAP financial measures should not be considered as a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. These non-GAAP financial measures do not reflect a comprehensive system of accounting, differ from GAAP measures with the same names, and may differ from non-GAAP financial measures with the same or similar names that are used by other companies.

We compute non-GAAP financial measures using the same consistent method from quarter to quarter and year to year. We may consider whether other significant items that arise in the future should be excluded from our non-GAAP financial measures.

We exclude the following items from all of our non-GAAP financial measures:

  • Share-based compensation expense
  • Amortization of acquired technology
  • Amortization of other acquired intangible assets
  • Goodwill and intangible asset impairment charges
  • Gains and losses on disposals of businesses and long-lived assets
  • Professional fees for business combinations

We also exclude the following items from non-GAAP net income (loss) and diluted net income (loss) per share:

  • Gains and losses on debt and equity securities and other investments
  • Income tax effects and adjustments
  • Discontinued operations

We believe these non-GAAP financial measures provide meaningful supplemental information regarding Intuit’s operating results primarily because they exclude amounts that we do not consider part of ongoing operating results when planning and forecasting and when assessing the performance of the organization, our individual operating segments, or our senior management. Segment managers are not held accountable for share-based compensation expense, amortization, or the other excluded items and, accordingly, we exclude these amounts from our measures of segment performance. We believe our non-GAAP financial measures also facilitate the comparison by management and investors of results for current periods and guidance for future periods with results for past periods.

The following are descriptions of the items we exclude from our non-GAAP financial measures.

Share-based compensation expenses. These consist of non-cash expenses for stock options, restricted stock units, and our Employee Stock Purchase Plan. When considering the impact of equity awards, we place greater emphasis on overall shareholder dilution rather than the accounting charges associated with those awards.

Amortization of acquired technology and amortization of other acquired intangible assets. When we acquire a business in a business combination, we are required by GAAP to record the fair values of the intangible assets of the business and amortize them over their useful lives. Amortization of acquired technology in cost of revenue includes amortization of software and other technology assets of acquired businesses. Amortization of other acquired intangible assets in operating expenses includes amortization of assets such as customer lists, covenants not to compete, and trade names.

Goodwill and intangible asset impairment charges. We exclude from our non-GAAP financial measures non-cash charges to adjust the carrying values of goodwill and other acquired intangible assets to their estimated fair values.

Gains and losses on disposals of businesses and long-lived assets. We exclude from our non-GAAP financial measures gains and losses on disposals of businesses and long-lived assets because they are unrelated to our ongoing business operating results.

Professional fees for business combinations. We exclude from our non-GAAP financial measures the professional fees we incur to complete business combinations. These include investment banking, legal, and accounting fees.

Gains and losses on debt and equity securities and other investments. We exclude from our non-GAAP financial measures gains and losses that we record when we impair available-for-sale debt and equity securities and other investments.

Income tax effects and adjustments. We use a long-term non-GAAP tax rate for evaluating operating results and for planning, forecasting, and analyzing future periods. This long-term non-GAAP tax rate excludes the income tax effects of the non-GAAP pre-tax adjustments described above, and eliminates the effects of non-recurring and period specific items which can vary in size and frequency. Based on our current long-term projections, we are using a long-term non-GAAP tax rate of 23% for fiscal 2020 and 24% for fiscal 2021. This long-term non-GAAP tax rate could be subject to change for various reasons including significant changes in our geographic earnings mix or fundamental tax law changes in major jurisdictions in which we operate. We will evaluate this long-term non-GAAP tax rate on an annual basis and whenever any significant events occur which may materially affect this rate.

Operating results and gains and losses on the sale of discontinued operations. From time to time, we sell or otherwise dispose of selected operations as we adjust our portfolio of businesses to meet our strategic goals. In accordance with GAAP, we segregate the operating results of discontinued operations as well as gains and losses on the sale of these discontinued operations from continuing operations on our GAAP statements of operations but continue to include them in GAAP net income or loss and net income or loss per share. We exclude these amounts from our non-GAAP financial measures.

Investors

Kim Watkins

Intuit Inc.

650-944-3324

[email protected]

Media

Karen Nolan

Intuit Inc.

650-944-6619

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Legal Software Internet Finance Banking Accounting Professional Services Technology

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Inventiva announces the publication in the Journal of Hepatology of new pre-clinical data showing the beneficial effects of lanifibranor on cirrhosis

  • The underlying studies aimed at characterizing the effects of the pan-PPAR agonist lanifibranor in two pre-clinical models of cirrhosis and in liver cells from cirrhotic patients
  • Lanifibranor showed clear beneficial effects leading to a marked improvement of fibrosis, portal hypertension and liver vascular resistance, three key elements of cirrhosis pathophysiology
  • Results in hepatic cells from cirrhotic patients further encourage the clinical evaluation of lanifibranor for the treatment of cirrhosis



Daix (France), December 7, 2020 – Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced the publication of a scientific paper on the beneficial effects of lanifibranor on experimental advanced chronic liver disease (ACLD) by the peer-reviewed scientific journal Journal of Hepatology.

The article, entitled “The pan-PPAR agonist lanifibranor improves portal hypertension and hepatic fibrosis in experimental advanced chronic liver disease”, discusses the effects of Inventiva’s lead drug candidate lanifibranor, a pan-peroxisome proliferator-activated receptor (pan-PPAR) agonist, in two distinct pre-clinical models of cirrhosis and in human liver cells from cirrhotic patients. The objective of the underlying studies was to evaluate the therapeutic potential of lanifibranor for the treatment of advanced cirrhosis.

Cirrhosis originates from a sustained hepatic injury that can vary in nature, with excessive alcohol consumption, unhealthy dietary habits and hepatitis B and C virus infections being the most common causes. As a consequence of long-term liver injury, tissue wound healing mechanisms may become deregulated, leading to hepatic fibrosis, which can ultimately progress to decompensated cirrhosis and, in some cases, hepatocellular carcinoma.1

The results of the pre-clinical studies show that lanifibranor improved portal hypertension, fibrosis and liver vascular resistance, three frequent and severe clinical syndromes associated with cirrhosis. The drug candidate also reduced ascites, sinusoidal capillarization, liver sinusoidal endothelial cells (LSEC) and hepatic stellate cells (HSC) activated phenotypes as well as microvascular function and liver inflammation. Furthermore, the results show that all three PPAR isoforms were downregulated in both cirrhotic patients as well as in the
pre-clinical models.

Moreover, differential expression of PPAR isoforms was observed in different liver cell types, emphasizing the importance of targeting all three isoforms for the treatment of cirrhosis. Finally, the findings also indicate that lanifibranor improved the phenotypes of isolated hepatocytes and hepatic stellate cells from cirrhotic patients, suggesting that the positive effects observed in both pre-clinical models could be translated to these patients.

Pierre Broqua, CSO and cofounder of Inventiva, commented:“We are very pleased to see our latest pre-clinical results on lanifibranor for the treatment of cirrhosis published in the renowned Journal of Hepatology. This scientific paper clearly illustrates that lanifibranor significantly improves key features of this severe disease, which still lacks a safe and effective treatment. The beneficial effects are based on our lead drug candidate lanifibranor’s capacity to target all three PPAR isoforms concomitantly and further encourage its clinical evaluation for the treatment of cirrhosis.”

Dr Jordi Gracia-Sancho, Head of the Liver Vascular Biology Team of IDIBAPS – Hospital Clínic de Barcelona and co-author of the article, added: “These studies, which combine two pre-clinical models of cirrhosis and human liver cells cultured in advanced in vitro systems, show that the pan-PPAR agonist lanifibranor improves the functionality of the cells that compose the liver microcirculatory system, leading to an improvement in portal hypertension and fibrosis. Considering the lack of treatments for advanced chronic liver disease, and its most deleterious complication portal hypertension, the findings included in this manuscript shed light on the way to develop novel therapies for patients with chronic hepatopathies.”



Publication details

Title of scientific paper: “The pan PPAR agonist lanifibranor improves portal hypertension and hepatic fibrosis in experimental advanced chronic liver disease”
Date of publication: December 2, 2020
Authors: Zoe Boyer-Diaz2, Peio Aristu-Zabalza3, María Andrés-Rozas4, Claude Robert5, Martí Ortega-Ribera6, Anabel Fernández-Iglesias7, Pierre Broqua8, Jean-Louis Junien9, Guillaume Wettstein10, Jaime Bosch11, Jordi Gracia-Sancho12
Link to the article:
https://authors.elsevier.com/sd/article/S0168-8278(20)33832-0

 



About lanifibranor

Lanifibranor, Inventiva’s lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator‑activated receptor (PPAR) isoforms, which are well‑characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well‑balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan‑PPAR agonist in clinical development. Inventiva believes that lanifibranor’s moderate and balanced pan‑PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and pre‑clinical studies to date. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of NASH.

About Inventiva

Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of NASH, MPS and other diseases with significant unmet medical need.

Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing two clinical candidates, as well as a deep pipeline of earlier stage programs.

Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies. Inventiva recently announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH and obtained Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH.

Inventiva is also developing odiparcil, a second clinical stage asset, for the treatment of patients with subtypes of MPS, a group of rare genetic disorders. Inventiva announced positive topline data from its Phase IIa clinical trial evaluating odiparcil for the treatment of adult MPS VI patients at the end of 2019 and received FDA Fast Track designation in MPS VI for odiparcil in October 2020.

In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. Furthermore, the Company has established a strategic collaboration with AbbVie in the area of autoimmune diseases. AbbVie has started the clinical development of ABBV‑157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. This collaboration enables Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the collaboration.

The Company has a scientific team of approximately 70 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly‑owned research and development facility.

Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (ticker: IVA – ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). www.inventivapharma.com



Contacts

Inventiva

Frédéric Cren
Chairman & CEO
[email protected]
+33 3 80 44 75 00

Brunswick Group

Yannick Tetzlaff / Tristan Roquet Montegon / 
Aude Lepreux
Media relations
[email protected]
+33 1 53 96 83 83

Westwicke, an ICR Company


Patricia L. Bank
Investor relations
[email protected]
+1 415 513 1284 

Important Notice

This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva’s clinical trials, clinical trial data releases, clinical development plans and anticipated future activities of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management’s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva’s control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, or that candidates will receive the necessary regulatory approvals. Actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including that Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, Inventiva’s future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva’s clinical trials may not support Inventiva’s product candidate claims, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva’s control, Inventiva’s product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva’s business, preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemic. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release.
Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the Universal Registration Document filed with the Autorité des Marchés Financiers on June 19, 2020 under n° D.20-0551 and its amendment filed on July 10, 2020 under n° D. 20-0551-A01 as well as the half-year financial report on June 30, 2020  for additional information in relation to such factors, risks and uncertainties.

Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

1 Pellicoro A, Ramachandran P, Iredale JP, et al. Liver fibrosis and repair: Immune regulation of wound healing in a solid organ. Nat Rev Immunol 2014;14:181–194.

2 Zoe Boyer-Diaz: MSc, Barcelona Liver Bioservices, Barcelona, Spain.

3 Peio Aristu-Zabalza: MSc, Barcelona Liver Bioservices, Barcelona, Spain.

4 María Andrés-Rozas: MSc, Barcelona Liver Bioservices, Barcelona, Spain.

5 Claude Robert: MSc, Inventiva, Daix, France.

6 Martí Ortega-Ribera: MSc, Liver Vascular Biology Research Group, IDIBAPS, Barcelona, Spain.

7 Anabel Fernández-Iglesias: PhD, Liver Vascular Biology Research Group, IDIBAPS, Barcelona, Spain & PhD, CIBEREHD, Madrid, Spain.

8 Pierre Broqua: PhD, Inventiva, Daix, France.

9 Jean-Louis Junien: PhD, Inventiva, Daix, France.

10 Guillaume Wettstein: PhD, Inventiva, Daix, France.

11 Jaime Bosch: MD & PhD, Liver Vascular Biology Research Group, IDIBAPS, Barcelona, Spain, CIBEREHD, Madrid, Spain, Hepatology, Department of Biomedical Research, University of Bern, Bern, Switzerland.

12 Jordi Gracia-Sancho: PhD, Barcelona Liver Bioservices, Barcelona, Spain, Liver Vascular Biology Research Group, IDIBAPS, Barcelona, Spain, CIBEREHD, Madrid, Spain, Hepatology, Department of Biomedical Research, University of Bern, Bern, Switzerland.

Attachment



Posted on

Espey Declares Regular Quarterly Dividend of $0.25 Per Share

SARATOGA SPRINGS, N.Y., Dec. 07, 2020 (GLOBE NEWSWIRE) — The Board of Directors of Espey Mfg. & Electronics Corp. (NYSE AMERICAN: ESP) has declared a regular quarterly dividend of $0.25 per share. The dividend will be payable on December 29, 2020 to all shareholders of record on December 22, 2020.

Espey’s primary business is the development, design, and production of specialized military and industrial power supplies/transformers.  The Company can be found on the Internet at www.espey.com.

For further information, contact Mr. David O’Neil at (518) 245-4400.

Certain statements in this press release are “forward-looking statements” and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements represent the Company’s current expectations or beliefs concerning future events. The matters covered by these statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements. The Company wishes to caution readers not to place undue reliance on any such forward-looking statements, which speak only as of the date made.



Posted on

IIROC Trading Halt – NOVA

Canada NewsWire

VANCOUVER, BC, Dec. 7, 2020 /CNW/ – The following issues have been halted by IIROC:

Company: Nova Mentis Life Science Corp.

CSE Symbol: NOVA

All Issues: No

Reason: At the request of the Company Pending News

Halt Time (ET): 3:46 PM

IIROC can make a decision to impose a temporary suspension (halt) of trading in a security of a publicly-listed company. Trading halts are implemented to ensure a fair and orderly market. IIROC is the national self-regulatory organization which oversees all investment dealers and trading activity on debt and equity marketplaces in Canada.

SOURCE Investment Industry Regulatory Organization of Canada (IIROC) – Halts/Resumptions