On March 2, 2022 Orion Corporation reported that has on 1 March 2022 transferred altogether 38,543 Orion Corporation B shares held by the company as a share reward for earning period 2019–2021 to the persons belonging to the Share-based Incentive Plan of the Orion Group (Press release, Orion , MAR 2, 2022, View Source [SID1234609392]). The transfer is based on the authorisation by the Annual General Meeting of 26 March 2019.

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The price per share of the transferred shares is EUR 41.3238, which is the volume weighted average quotation of the Orion Corporation B share on 1 March 2022. Accordingly, the total transaction price of the transferred shares is EUR 1,592,743.22.

After the share transfer, the total number of own B shares held by Orion Corporation is 532,771.

Orion Corporation has informed about the Share-based Incentive Plan in stock exchange release on 6 February 2019.

On March 2, 2022 Avalo Therapeutics, Inc. (Nasdaq: AVTX), a leading clinical-stage precision medicine company that discovers, develops, and commercializes targeted therapeutics for patients with significant unmet need in immunology and rare genetic diseases, reported business updates and year-end financial results for 2021 (Press release, Avalo Therapeutics, MAR 2, 2022, View Source [SID1234609391]).

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"2021 was an important year for Avalo in that the Company produced compelling data for AVTX-002 in both acute and chronic inflammatory diseases. Furthermore, it positioned the Company to launch a placebo-controlled trial in NEA (AVTX-002), as well as two rare disease pivotal trials in 2022," said Dr. Garry Neil, Chief Executive Officer of Avalo Therapeutics. "We are focused on the operational execution of these programs and their corresponding milestones, which have great potential to drive shareholder value in the coming year. We believe the recent pipeline prioritization will allow for greater focus on these most promising programs while also allowing for a reduction in cash burn."

Business Updates:

Promoted Dr. Garry Neil to Chief Executive Officer and Chris Sullivan to Chief Financial Officer. Dr. Neil brings to this position extensive clinical development and leadership experience in the biopharmaceutical industry including his current role as Chairman of the Board for Arena Pharmaceuticals and prior senior positions in leading pharmaceutical companies including Johnson & Johnson, Merck and AstraZeneca. Mr. Sullivan brings strong financial leadership to Avalo from his prior senior level finance/accounting positions for various Nasdaq-listed life science companies and Ernst & Young.
Appointed June Almenoff M.D., Ph.D., and Mitchell Chan to the Board of Directors. Dr. Almenoff brings close to 25 years of leadership experience focused on research and development and commercialization including her time as the President and Chief Medical Officer of Furiex Pharmaceuticals. Mr. Chan has more than 15 years of finance experience in the life sciences industry including his time as Chief Financial Officer of Viela Bio and senior financial positions at AstraZeneca and Genentech-Roche.
Announced plans to conduct a new Phase 2 randomized, double-blind, placebo-controlled trial of AVTX-002 for the treatment of moderate to severe NEA; top-line data anticipated in the fourth quarter of 2022. NEA is subtype of asthma with a poor prognosis that encompasses approximately half of asthma patients. Biomarker data suggests that LIGHT plays a strong role in inflammation and airway remodeling in NEA and support the development of AVTX-002 for poorly controlled NEA patients.
Optimized the pipeline, with Avalo winding down internal development efforts of AVTX-006 in lymphatic malformations and AVTX-007 for the treatment of multiple myeloma (as previously announced) while pausing current development efforts for AVTX-802 (MPI-CDG). We plan to pursue strategic alternatives for AVTX-006. Avalo also intends to focus on placebo-controlled trials for AVTX-002 going forward, starting with NEA. We will therefore not be moving forward with the uncontrolled cohort of AVTX-002 in ulcerative colitis (UC) patients. Avalo will consider planning for a possible randomized, double-blind, placebo-controlled clinical study in moderate to severe refractory patients with inflammatory bowel disease.
Presented data from Phase 1b, open-label, dose-escalation, signal-finding, multi-center study evaluated the safety, tolerability, pharmacokinetics, and short-term efficacy of AVTX-002 in adults with moderate to severe, active Crohn’s disease (CD) who have previously failed anti-tumor necrosis factor alpha (anti-TNFα) treatment. Fifty percent (4/8 patients) demonstrated evidence of mucosal healing as determined by colonoscopy and adjudicated by a central reader with one patient achieving remission (SES-CD=0).
Program Updates and Milestones:

AVTX-002: Anti-LIGHT monoclonal antibody (mAb) targeting immune-inflammatory diseases including Non-eosinophilic Asthma and inflammatory bowel disease (Crohn’s disease and Ulcerative Colitis).
Non-eosinophilic Asthma: An investigational new drug (IND) application is active for AVTX-002 for the treatment of NEA and Avalo expects to initiate a Phase 2 randomized, double-blind, placebo-controlled Phase 2 clinical trial in 80 patients with poorly controlled NEA. Top-line data from the trial are currently expected in the fourth quarter of 2022.
Inflammatory Bowel Disease: Presented positive Phase 1b data in CD with efficacy signal demonstrated in heavily pre-treated patients supports further evaluation in inflammatory bowel disease patients’ refractory to three or more treatments, including anti-TNFα and other biologics. As Avalo intends to focus on placebo-controlled trials for AVTX-002 going forward, we will not be moving forward with the uncontrolled cohort of AVTX-002 in UC patients. Avalo will consider planning for a possible randomized, double-blind, placebo-controlled clinical study in moderate to severe refractory patients in inflammatory bowel disease.

AVTX-007: Anti-IL-18 mAb targeting adult-onset Still’s disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA).
AOSD: AVTX-007 is being evaluated in a multicenter, Phase 1b study in 12 refractory or steroid-dependent patients with AOSD in two cohorts. Management is currently reviewing preliminary data and the path forward related to this indication. Top-line data currently expected in 2023, though this is subject to change and refinement pending finalization of the review.
Multiple Myeloma: Data from a multicenter, Phase 1b study in relapsed and refractory multiple myeloma patients indicated AVTX-007 was generally safe and well tolerated at doses up to 14mg/kg. Additionally, pharmacodynamic data indicate deep reductions in IL-18 levels occur withing 24-hours after dosing. However, as previously announced, due to a lack of efficacy signal Avalo is winding down internal development efforts in this indication.
AVTX-006: Dual mTORc1/c2 small molecule inhibitor for lymphatic malformations.
As a result of a portfolio prioritization review, Avalo is winding down internal development of AVTX-006 and has decided to pursue strategic alternatives for this program.

AVTX-800 programs (AVTX-801, AVTX-802, and AVTX-803): Therapeutic doses of monosaccharide therapies for congenital disorders of glycosylation (CDGs).
Avalo is in the process of initiating a single-center (US), double-blind (followed by an open-label extension) pivotal study of AVTX-803 in patients with leukocyte adhesion deficiency type II (LAD II) caused by loss-of-function mutation in the SLC35C1 gene, with pivotal trial data expected in the fourth quarter of 2022.
Avalo and the study sponsor remain in dialogue with the FDA to align on a suitable clinical study design for AVTX-801 (PGM1-CDG). Pivotal trial data are expected in 2023. Avalo is currently working with the study sponsor to refine milestone timing.
The Company is pausing internal development of AVTX-802 (MPI-CDG) at this time due to challenges with study feasibility.
2021 Financial Update:

As of December 31, 2021, Avalo had $54.6 million in cash and cash equivalents, representing a $35.7 million increase as compared to December 31, 2020. The increase was primarily driven by gross proceeds of approximately $72.2 million from underwritten public offerings and $35.0 million from a debt facility. Such increases were partially offset by operating expenditures, the majority of which were related to pipeline development.

Total operating expenses increased $8.0 million for the year ended December 31, 2021 as compared to the year ended December 31, 2020. The increase in operating expenses was largely driven by a $27.6 million increase in research and development expenses to support our maturing pipeline and a $4.4 million increase in general and administrative expenses, partially offset by a $25.5 million reduction in acquired in-process research and development expense as this charge in 2020 did not repeat.

The consolidated balance sheets as of December 31, 2021 and 2020 have been derived from the audited financial statements, but do not include all of the information and footnotes required by accounting principles accepted in the United States for complete financial statements.

The consolidated statements of operations for the years ended December 31, 2021 and 2020 have been derived from the audited financial statements, but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

On March 2, 2022 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that its Senior Vice President and Chief Financial Officer, Jonathan Guarino, has been invited to attend the Q1 Virtual Investor Summit (Press release, Soligenix, MAR 2, 2022, View Source [SID1234609390]). The conference will take place March 8-9, 2022, and includes one-on-one meetings and a Company presentation with Q&A at 1:15 P.M. EST on Tuesday, March 8, 2022. The presentation will be available to registered conference attendees via the event platform link. The presentation will be webcast and an archived recording will be made available on the "Investor Events" page of the Company’s website.

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If you are unable to attend the conference and would like to schedule a meeting with management, please contact [email protected].

For more information about the Q1 Virtual Investor Summit, please refer to the conference website at View Source

On March 2, 2022 HOOKIPA Pharma Inc. (Nasdaq: HOOK), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported the pricing of an underwritten public offering of 21,700,000 shares of its common stock and 15,800 shares of its non-voting Series A-1 convertible preferred stock (the "Offering") (Press release, Hookipa Biotech, MAR 2, 2022, View Source [SID1234609389]). The public offering price of each share of common stock is $2.00 and the public offering price of each share of non-voting Series A-1 preferred stock is $2,000 (each share of non-voting Series A-1 preferred stock is convertible into 1,000 shares of common stock). HOOKIPA has granted the underwriters a 30-day option to purchase up to an additional 5,625,000 shares of its common stock at the public offering price of the common stock, less underwriting discounts and commissions. The gross proceeds to HOOKIPA from this offering are expected to be $75.0 million, before deducting underwriting discounts and commissions and other offering expenses and excluding any exercise of the underwriters’ option to purchase additional shares. All of the securities in the Offering are to be sold by HOOKIPA. The Offering is expected to close on March 4, 2022, subject to customary closing conditions.

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SVB Leerink and RBC Capital Markets are acting as joint book-running managers of the Offering.

The securities described above are being offered by HOOKIPA pursuant to a shelf registration statement on Form S-3 (No. 333-238311), including a base prospectus filed with the Securities and Exchange Commission (the "SEC"), which was declared effective on May 27, 2020. A preliminary prospectus supplement has been filed with the SEC. A final prospectus supplement and accompanying prospectus relating to the Offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained, when available, from SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston Massachusetts 02109, by telephone at 1-800-808-7525 ext. 6105, or by email at [email protected]; RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, New York, NY 10281, by telephone at 877-822-4089, or by email at [email protected].

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 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.

On March 2, 2022 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update (Press release, Jounce Therapeutics, MAR 2, 2022, View Source [SID1234609388]).

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"2021 proved to be a very productive year with significant progress in our two clinical proof of concept programs, while continuing our commitment to discovery of novel therapeutic candidates. As we enter 2022, we are strongly positioned for clinical data read outs from INNATE and SELECT, with a cash runway to extend beyond important inflection points. Our novel therapeutics and biomarker approaches are aimed at bringing meaningful clinical benefit to important areas of unmet need, especially those patients whose tumors are PD-(L)1 inhibitor resistant," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "Our approaches to targeting different types of immune cells in the tumor microenvironment are driven by the evolving needs of patients and supported by the science underlying immune cells interactions, with the goal of generating improved anti-tumor immune response. We believe Jounce is well poised to further our goal of bringing the right immunotherapies to the right patients."

Pipeline Update and Highlights:

JTX-8064 (LILRB2 / ILT4)

Completed JTX-8064 monotherapy and pimivalimab combination dose escalation portions of the INNATE trial. As the company previously announced, JTX-8064 had an acceptable safety profile with no observed dose limiting toxicities in the completed dose escalation portion of INNATE. Jounce selected a recommended phase 2 dose of 700 mg to be utilized in the expansion cohorts.
Initiated enrollment in indication-specific JTX-8064 monotherapy and pimivalimab combination expansion cohorts in the Phase 2 portion of the INNATE trial: In October 2021, Jounce announced the commencement of the enrollment in eight indication-specific monotherapy and combination expansion cohorts in patients with advanced solid tumors.
Vopratelimab (ICOS) and pimivalimab (PD-1)

Continued enrollment in Phase 2 SELECT trial of vopratelimab: SELECT is a randomized Phase 2 trial to evaluate vopratelimab in combination with pimivalimab versus pimivalimab alone in immunotherapy naïve, TISvopra biomarker-selected, second line non-small cell lung cancer patients. The SELECT trial will also provide important single agent data for pimivalimab in a new biomarker selection paradigm. Jounce is on track to report data from the SELECT trial in the second half of 2022.
Continued to advance pimivalimab as a combination agent: Pimivalimab is a PD-1 inhibitor intended for combination with Jounce’s broad pipeline with its two ongoing proof of concept studies, the INNATE trial and the SELECT trial.
JTX-1484 (LILRB4/ILT3)

JTX-1484 is the most recent product candidate to emerge from our Translational Science Platform. JTX-1484 is a monoclonal antibody designed to block human LILRB4 expressed on immune-suppressive myeloid cells in the tumor microenvironment with the potential to reduce immune suppression of and enhance T cell functionality. JTX-1484 is currently in IND-enabling activities, with the goal of filing an IND in 2023.
Discovery Pipeline

Productive discovery engine with the goal of an IND every 12 to 18 months: Jounce continues to invest in and advance its growing immuno-oncology pipeline. Its discovery engine is built upon the capability to thoroughly investigate different cell types in the tumor microenvironment, including T cells and myeloid cells.
Fourth Quarter and Full Year 2021 Financial Results:

Cash position: As of December 31, 2021, cash, cash equivalents and investments were $220.2 million, compared to $213.2 million as of December 31, 2020. The increase in cash, cash equivalents and investments was primarily due to receipt of $90.9 million in net proceeds from the follow-on public offering and sales under Jounce’s at-the-market offering program completed in the first quarter of 2021, and receipt of a $25.0 million milestone from Gilead Sciences, Inc., or Gilead, in the third quarter of 2021, offset by operating expenses incurred.
License and collaboration revenue: No license and collaboration revenue was recognized during the fourth quarter of 2021. Jounce recognized $62.3 million of license and collaboration revenue for the same period in 2020. License and collaboration revenue was $26.9 million for the full year 2021, compared to $62.3 million for the full year 2020. Revenue recognized during 2021 was related to milestone achievement and completion of research and transition services under Jounce’s license agreement with Gilead (the "Gilead License Agreement"). Revenue recognized during 2020 was related to the grant of the GS-1811, formerly JTX-1811, license and performance of research and transition services under the Gilead License Agreement.
Research and development expenses: Research and development expenses were $23.1 million for the fourth quarter of 2021, compared to $20.0 million for the same period in 2020. Research and development expenses were $89.0 million for the full year 2021, compared to $78.7 million for the full year 2020. The increase in research and development expenses for the full year 2021 was due to $5.1 million of increased research and development expenses primarily associated with manufacturing activities for our development programs; $2.9 million of increased employee compensation costs; and $2.6 million of increased clinical and regulatory expense primarily attributable to our INNATE and SELECT clinical trials.
General and administrative expenses: General and administrative expenses were $7.2 million for the fourth quarter of 2021, compared to $6.9 million for the fourth quarter of 2020. General and administrative expenses were $29.0 million for the full year 2021, compared to $28.8 million for the full year 2020. The increase in general and administrative expenses for full year 2021 was primarily attributable to increased other administrative costs.
Net (loss) income: Net loss was $30.2 million for the fourth quarter of 2021, resulting in basic and diluted net loss per share of $0.59. Net income was $35.5 million for the same period in 2020, resulting in basic net income per share of $0.90 and diluted net income per share of $0.86. Net loss was $90.9 million for the full year 2021, resulting in basic and diluted net loss per share of $1.82. Net loss was $43.8 million for the full year 2020, resulting in basic and diluted net loss per share of $1.24. The increase in net loss and net loss per share was attributable to increased operating expenses and reduced revenue recognized under the license agreement with Gilead and during the year ended 2021 as compared to 2020.
Financial Guidance:

Based on its current operating and development plans, Jounce reiterates its financial guidance for 2022. Gross cash burn on operating expenses and capital expenditures for the full year 2022 is expected to be approximately $115.0 million to $130.0 million. Given the strength of its balance sheet, Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements through the third quarter of 2023.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 8998936. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcast will be archived and made available for replay on Jounce’s website approximately two hours after the call and will be available for 30 days.

About JTX-8064

JTX-8064 is a humanized IgG4 monoclonal antibody designed to specifically bind to Leukocyte Immunoglobulin Like Receptor B2 (LILRB2/ILT4) and block interactions with its ligands. JTX-8064 is the first tumor-associated macrophage candidate developed from Jounce’s Translational Science Platform. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting and the 2019 and 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meetings support the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity. A Phase 1/2 clinical trial named INNATE (NCT04669899) of JTX-8064 as a monotherapy and in combination with Jounce’s internal anti-PD-1 inhibitor, pimivalimab (formerly JTX-4014) is currently enrolling patients with advanced solid tumors into tumor-specific expansion cohorts.

About Pimivalimab

Pimivalimab (formerly JTX-4014) is a well-characterized fully human IgG4 monoclonal antibody designed to block binding to PD-L1 and PD-L2. Pimivalimab demonstrated a 17% durable overall response rate in a Phase 1 trial of 18 heavily pre-treated PD-(L)1 inhibitor naïve patients, which excluded all tumor types for which PD-(L)1 inhibitors were approved. In this Phase 1 trial, pimivalimab was shown to have an acceptable safety profile. Pimivalimab is currently being assessed in the INNATE Phase 1 trial (NCT04669899) in combination with JTX-8064, a LILRB2 (ILT4) inhibitor. Pimivalimab is also being assessed in the SELECT Phase 2 clinical trial (NCT04549025) in combination with vopratelimab, a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors.

About Vopratelimab

Vopratelimab is a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors. Vopratelimab is currently being assessed in the SELECT Phase 2 clinical trial (NCT04549025) in combination with Jounce’s internal investigational PD-1 inhibitor, pimivalimab (formerly JTX-4014), compared to pimivalimab alone. The SELECT trial is currently enrolling approximately 75 immunotherapy naïve NSCLC patients who have been pre-selected with the TISvopra predictive biomarker, an 18 gene RNA tumor inflammation signature which predicted the emergence of ICOS hi CD4 T cells and clinical benefit in the ICONIC trial of vopratelimab alone and in combination with a PD-1 inhibitor. SELECT is powered to demonstrate the statistical superiority of the combination of vopratelimab plus pimivalimab compared to pimivalimab.