On March 10, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that scheduled in-person presentation at the Barclays Global Healthcare Conference in Miami Beach was changed by conference organizers to a webcast only, as the conference has been reconfigured (Press release, Ligand, MAR 10, 2020, View Source [SID1234555367]). The webcast will take place as previously scheduled at 2:35 p.m. ET and is available here. Conference one-on-one investor meetings have been moved to telephone calls, and the new slides Ligand will be using during those meetings have been posted to www.ligand.com.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The new slides contain recent pipeline and business updates, including:

Palvella Therapeutics completed enrollment in the Phase 2/3 pivotal study of PTX-022 for treatment of pachyonychia congenita, with topline data expected in Q4. PTX-022 is a Fast Track-designated program.
Gloria Pharmaceuticals, Ligand’s partner for the OmniAb-derived anti-PD-1 antibody zimberelimab in China, announced they are filing for marketing authorization in China based on positive Phase 2 data in classical Hodgkin’s lymphoma. This program joins C-Stone’s CS1001 as another OmniAb antibody that may be approved in 2020. OmniAb-derived zimberelimab is also in development in the U.S. by partner Arcus Biosciences.
In addition to zimberelimab, Ligand’s portfolio of partnered programs includes six new products that could launch by the end of 2022 including Takeda’s pevonedistat, Retrophin’s sparsentan, Eisai’s parempanel-IV, Palvella’s PTX-022, Xi’an Xintong’s Pradefovir and C-Stone’s CS-1001. Additional partnered programs could launch in this timeframe as well.
Retrophin announced enrollment of the first 190 patients in its pivotal Phase 3 DUPLEX study of Sparsentan in Focal Segmental Glomerulosclerosis. Topline efficacy data from the 36-week proteinuria endpoint analysis of the trial are expected in the first quarter of 2021.
Nucorion Pharmaceuticals completed filing of an IND for its novel liver-targeted hepatitis B program NC0-1010, obtained FDA acceptance of the IND and is on track for initiation of a Phase 1 clinical trial in the U.S in March. This is the first clinical-stage program to leverage Ligand’s novel, internally developed LTP Technology Platform.
Ligand continues to support Captisol orders from partners related to remdesivir, an investigational product candidate being actively assessed in Phase 2 and Phase 3 clinical studies to treat COVID-19, with the first studies expected to be completed in April.
"2020 is off to an excellent start, with a good flow of news and updates from our partnered portfolio. We are facing the most substantial calendar of partner events in our history and see the potential for several major new product launches over the next couple of years," said John Higgins, Chief Executive Officer of Ligand. "Our OmniAb business is doing very well, with two antibody-based drugs filed or expected to be filed for potential approval."

"We have also been very active working with partners to meet their Captisol needs to formulate clinical supplies of the antiviral drug remdesivir, which is being studied as a potential treatment for COVID-19," he added. "Our team has made substantial progress over the past few weeks working with partners to provide supply-chain support that was not anticipated at the start of the year."

About Captisol

Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products including Amgen’s KYPROLIS, Baxter International’s NEXTERONE, Acrotech Biopharma L.L.C.’s and CASI Pharmaceuticals’ EVOMELA, Melinta Therapeutics’ BAXDELA and Sage Therapeutics’ ZULRESSO. There are many Captisol-enabled products currently in various stages of development.

On march 10, 2020 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to leveraging the microbiome organ to treat disease and improve human health, reported that Alison Lawton, President and Chief Executive Officer, will present during Chardan’s 2nd Annual Microbiome Medicines Summit, a virtual event, on Monday, March 16, 2020 at 4:15 p.m. ET (Press release, Kaleido Biosciences, MAR 10, 2020, View Source [SID1234555366]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A webcast of the presentation can be accessed on the Investors & Media section of Kaleido’s website at View Source An archived replay will be available for 90 days following the event.

On March 10, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTCQB: IPATF) reported financial results for its fiscal year 2020 third quarter ended January 31, 2020 (Press release, ImmunoPrecise Antibodies, MAR 10, 2020, View Source [SID1234555365]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Revenue. The Company posted a quarterly revenue of $4,034,440, an increase of 50% from the year-ago quarter and an all-time record. The increasing revenue trend is due to growth in both the volume and financial value of client contracts. Revenue outlook is positive for the fourth quarter.

Gross Margin. During the three months ended January 31, 2020, the Company achieved a gross profit of $2,223,669.

Net Loss. The Company reported a record low for net loss of $625,837, during the three months ended January 31, 2020, representing a decrease of 47% in net loss from the year-ago quarter. The decrease in net loss is due to a $655,614 increase in gross profit, as well as recognized cost synergies resulting in lower spend, offset by higher non-cash amortization of intangible assets, depreciation of leased assets as a result of implementing IFRS 16, Leases.

Non-IFRS Measures*. For the first time in the Company’s history, Adjusted EBITDA for the quarter and the nine-month period ending January 31, 2020, was positive, at $717,716 and $18,356, respectively, compared to ($461,353) and ($1,553,090) for the same periods last year. The positive Adjusted EBITDA is a result of the third quarter’s 50% increase in revenue and lower adjusted operating expenses compared to the prior year’s quarter and nine-month period.

"We are pleased to report IPA’s record quarterly revenue and earnings, which was fueled by strong demand for a wide variety of our products and services in tool, research and therapeutic antibody discovery and manufacturing," said Jennifer Bath, IPA’s President and CEO. "Careful attention to operational prioritization, site efficiencies and brand recognition in 2019 led to new vendor qualifications from pharmaceutical and biotech companies, enabling larger allocations of corporate budgets in the 2020 calendar year. This past quarter is a powerful testament to the satisfaction and engagement of our clients, and the realization of leveraged synergies globally."

Recent ImmunoPrecise Highlights:

• IPA Launched Coronavirus Vaccine and Therapeutic Programs
• As IPA Directs R&D Efforts Toward Coronavirus, Company is Added to WHO Draft Landscape of Companies Combating COVID-19
• Company Announced AI Collaboration with EVQLV, Inc., to Accelerate the Efforts in the Development of a Coronavirus Therapeutic
• IPA Integrated SGI’s DNA Automated DNA Printer at Utrecht Site
• IPA Subsidiary, UPE, Joining Genmab and Merus in Expansion to New Biotech Accelerator in the Center of European Science Industry

IPA periodically provides information for investors on its corporate website, ImmunoPrecise.com. This includes press releases and other information on financial performance, reports filed or furnished with the TSX, information on corporate governance and details related to its annual meeting of shareholders. Reports filed or furnished with the TSX can be found at sedar.com.

On March 10, 2020 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics targeting infectious diseases and cancers based on its proprietary arenavirus platform, reported that it will release fourth quarter and full year 2019 financial results before the market opens on Thursday, March 19, 2020 (Press release, Hookipa Pharma, MAR 10, 2020, View Source [SID1234555364]). Following the release, the Company will host a live conference call and webcast at 8:00 a.m. EDT to discuss its financial results and corporate update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To access the live conference call, please dial +1-631-510-7495 (from the US) or +44-207-1 92-8000 (international) and refer to conference ID 1769733. A live audio webcast of the event will also be available within the Investors & Media section of HOOKIPA’s website at View Source An archived replay will be accessible for 30 days following the event.

On March 10, 2020 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported its fourth-quarter and full-year 2019 financial results (Press release, Constellation Pharmaceuticals, MAR 10, 2020, View Source [SID1234555363]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The fourth quarter of 2019 was transformational for Constellation," said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. "The Company is now advancing toward its goal of becoming a fully integrated oncology company, with broad-based capabilities from target identification and compound discovery to translational science, clinical development, and commercialization. We presented encouraging preliminary data at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December showing signals of activity for CPI-0610 across a broad range of disease parameters in myelofibrosis. These data suggest possible disease-modifying effects, such as bone marrow fibrosis improvements and hemoglobin increases, in addition to spleen volume reductions and symptom score improvements. We also raised capital in December, extending our cash runway into the second half of 2022.

"We are targeting CPI-0610 in combination with ruxolitinib to become the standard of care in first-line treatment of myelofibrosis," Mr. Raythatha continued. "In second-line patients who have previously been treated with ruxolitinib, CPI-0610 could potentially provide meaningful benefits as a monotherapy or as an add-on to ruxolitinib.

"We look forward to discussions on CPI-0610 with regulatory agencies in the coming year. These discussions will help refine our plans for a potential registration path for CPI-0610, including our plan to initiate a global randomized Phase 3 clinical trial of CPI-0610 + ruxolitinib in JAK-inhibitor-naïve MF patients in the third quarter of 2020.

"We are also working to create value for patients in other ways," Mr. Raythatha concluded. "We believe that CPI-0610 may benefit patients with other hematologic and oncology diseases. In addition, our EZH2-inhibitor franchise of CPI-1205 and CPI-0209 provides potential opportunities to treat a wide range of oncology patients. Our robust discovery platform is expected to deliver a steady stream of clinical candidates in coming years."

Program Updates

CPI-0610

Submitted abstracts for the European Hematology Association (EHA) (Free EHA Whitepaper) annual meeting in June 2020
Expect to present 24-week data on 25-30 first-line (1L) and 70-80 second-line (2L) patients at EHA (Free EHA Whitepaper)
Continuing enrollment in previously expanded Arm 3 (1L combo patients) and Cohort 2A (2L combo transfusion-dependent patients)
Expanding Cohort 1A (2L monotherapy transfusion-dependent patients) from 16 to up to 60 patients based on conversions of transfusion-dependent patients to transfusion independence
Received orphan drug designation for CPI-0610 from the FDA and EMA
CPI-1205

Completed Phase 2 enrollment in our ProSTAR trial
Planning for data cut and analysis in mid-2020, with a clear signal required to move program into Phase 3
CPI-0209

Ongoing Phase 1 dose escalation phase of Phase 1/2 clinical trial studying CPI-0209 monotherapy in advanced, relapsed solid tumor patients
Aim to determine recommended Phase 2 dose (RP2D) for monotherapy in second half of 2020
After determining RP2D, intend to initiate Phase 2 expansion arms for monotherapy in selected solid tumor indications as well as dose escalation studies of combinations with other therapies
Employing biomarker strategy that includes assessment of ARID1A mutations
Milestones

The Company anticipates achieving the following milestones during 2020:

CPI-0610 – Provide MANIFEST program update at EHA (Free EHA Whitepaper) in June

CPI-0610 – Initiate Phase 3 clinical trial in the third quarter

CPI-0610 – Provide additional MANIFEST program update by yearend

CPI-1205 – Provide ProSTAR program update mid-year

CPI-0209 – Provide program update, including recommended Phase 2 dose, by end of year

Fourth Quarter 2019 Financial Results

Cash, cash equivalents, and marketable securities as of December 31, 2019, were $383.9 million, an increase of 235.0% compared to December 31, 2018, primarily due to proceeds from the private placement in October 2019 and the public offering in December 2019, offset by operating expenses.
Research and development (R&D) expenses increased 11.8% year over year to $18.6 million in the fourth quarter of 2019 mainly due to increased clinical trial expenses.
General and administrative (G&A) expenses grew 36.6% year over year to $5.5 million in the fourth quarter of 2019, primarily due to building out the organization of the company.
The net loss attributed to common shareholders increased 21.4% year over year to $24.2 million for the fourth quarter of 2019, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders decreased 10.4% to $0.69 per share due to an increase in weighted average shares outstanding as a result of the private placement in October 2019 and the public offering in December 2019, offset in part by the increased net loss.
Full Year 2019 Financial Results

Research and development (R&D) expenses increased 36.3% year over year to $66.5 million in full-year 2019, mainly due to increased clinical trial expenses.
General and administrative (G&A) expenses grew 57.1% year over year to $19.6 million in full-year 2019, primarily due to building out the organization of the company.
The net loss attributed to common shareholders increased 42.8% year over year to $85.6 million for full-year 2019, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders decreased 39.2% to $3.04 per share largely due to an increase in weighted average shares outstanding as a result of the initial public offering and related conversion of preferred stock to common stock in July 2018 and the additional shares issued in 2019.
Financial Guidance

Constellation expects that its current cash, cash equivalents, and marketable securities will enable it to fund operations into the second half of 2022.