On August 4, 2022 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, reported that Russ Trenary, President and Chief Executive Officer of Outlook Therapeutics, will present at the H.C. Wainwright 2nd Annual Ophthalmology Conference being held virtually on Wednesday, August 17 (Press release, Outlook Therapeutics, AUG 4, 2022, View Source [SID1234617585]).

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In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

A video webcast of the presentation will be accessible for viewing on-demand beginning on Wednesday, August 17, 2022, at 7:00 AM ET for those registered for the event and will be available on the Events page in the Investors section of the Company’s website (outlooktherapeutics.com). The webcast replay will be archived for 90 days following the event.

On August 4, 2022 Ascendis Pharma A/S (Nasdaq: ASND) reported that the company will hold a conference call and live webcast on Wednesday, August 10, 2022, at 4:30 p.m. Eastern Time (ET) to review its second quarter 2022 financial results and provide a business update (Press release, Ascendis Pharma, AUG 4, 2022, View Source [SID1234617584]).

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Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at View Source A replay of the webcast will be available on this section of our website shortly after conclusion of the event for 30 days.

On August 4, 2022 Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines designed to bring the curative power of stem cell transplant to more patients, reported financial results for the second quarter ending June 30, 2022, and recent program highlights (Press release, Magenta Therapeutics, AUG 4, 2022, View Source [SID1234617583]).

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"We continue to execute across the portfolio while maintaining our prioritized spending and program investment. We look forward to collecting additional data from multiple cohorts in our MGTA-117 Phase 1/2 dose escalation clinical trial and plan to disclose interim results in Q4 2022," said Jason Gardner, President and Chief Executive Officer of Magenta Therapeutics. "As our CD45 antibody drug conjugate program continues to progress with concept-validating preclinical data, we expect to be able to provide an overview of the program’s clinical development plan and its anticipated timelines later this year as well. Finally, we are excited about initiating the MGTA-145 stem cell mobilization clinical trial in sickle cell disease at leading research hospitals to understand MGTA-145’s potential for better mobilization that could result in better outcomes for patients with this debilitating disease."

Program Highlights:
MGTA-117 Phase 1/2 Clinical Trial Progression and Data Disclosure Expectations
MGTA-117 is Magenta’s most advanced targeted conditioning product candidate. The program is in a Phase 1/2 clinical trial in patients with relapsed/refractory acute myeloid leukemia, or AML, and myelodysplastic syndromes, or MDS. MGTA-117 is an anti-CD117 antibody conjugated to an amanitin payload, and it is designed to target CD117, also known as c-Kit, which is highly expressed on hematopoietic stem cells and leukemic cells.

The MGTA-117 clinical trial continues to make progress with additional clinical trial site activations, patient identification, patient screening and enrollment.
Magenta expects clinical data from additional dose-escalation cohorts will support its earlier reported clinical observations from Cohort 1, which indicated evidence of MGTA-117’s potential to bind CD117+ cells, reduce CD117+ erythroid progenitor cells in the bone marrow, reduce leukemic blasts in the bone marrow, rapidly clear the body and maintain a favorable tolerability profile.
Magenta expects to report interim clinical data from multiple dose-escalation cohorts from the clinical trial in Q4 2022.
Magenta anticipates using the interim clinical data from this trial to engage with regulatory authorities to plan for the transition of the trial into transplant-eligible AML patients. Although the timing and scope of the discussion with regulators will be determined by the available clinical data, Magenta anticipates engagement with regulators in Q4 2022.
Magenta also expects the interim clinical data to inform next steps towards development of MGTA-117 as a conditioning agent for autologous gene therapy, including existing clinical collaboration partnerships in hemoglobinopathies and lysosomal storage disorders, with Beam Therapeutics and AVROBIO, Inc. respectively.
Magenta will participate in both the BTIG 2022 Virtual Biotechnology Conference on Monday, August 8th, 2022 and the Gene Modulation Panel Discussion at the 2022 Wedbush PacGrow Healthcare Conference, to be held virtually, on Tuesday, August 9th, 2022 at 9:45 a.m. ET. A live webcast of the Gene Modulation Panel can be accessed via the Magenta Therapeutics website at View Source
CD45-Antibody Drug Conjugate (ADC): Second Targeted Conditioning Program
CD45 is broadly expressed on hematopoietic cells and Magenta’s CD45-ADC is designed to selectively target and deplete both stem cells and lymphocytes, and is intended to enable patients with blood cancers and autoimmune diseases to avoid the use of chemotherapy prior to stem cell transplant.

Magenta has recently completed the in-life portion of a dose-ranging toxicology study and will use the resulting data to inform dosing for its planned GLP toxicology study. Other IND-enabling activities and plans are ongoing. Magenta expects to provide a further update on the CD45 program in Q4 2022.
MGTA-145 Stem Cell Mobilization and Collection
Magenta is developing MGTA-145, in combination with plerixafor, to improve the process by which stem cells are stimulated out of the bone marrow and into the bloodstream, so they are available for collection for future re-infusion, known as stem cell mobilization, which is required for all transplants and ex vivo gene therapy applications.

Magenta has initiated a Phase 2 clinical trial in sickle cell disease (SCD) at multiple clinical trial sites. The clinical trial operates in collaboration with bluebird bio to evaluate the utility of MGTA-145, in combination with plerixafor, for the mobilization and collection of stem cells in patients with SCD where mobilization and collection are difficult and there is a clear unmet medical need. Magenta expects initial data from this trial in Q4 2022.
Financial Results:
Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2022, were $139.4 million, compared to $176.9 million as of December 31, 2021. Magenta anticipates that its cash, cash equivalents and marketable securities will be sufficient to fund its current operational plan into Q2 2024.

Research and Development Expenses: Research and development expenses were $11.6 million in the second quarter of 2022, compared to $11.1 million in the second quarter of 2021. The increase was driven primarily by higher preclinical and manufacturing costs to support our IND enabling studies for CD45-ADC, offset by a decrease in costs related to our completed Phase 2 investigator-initiated clinical trial in multiple myeloma patients.

General and Administrative Expenses: General and administrative expenses were $6.5 million for both the second quarter of 2022 and the second quarter of 2021.

Net Loss: Net loss was $17.3 million for the second quarter of 2022, compared to net loss of $16.9 million for the second quarter of 2021.

On August 4, 2022 Amgen (NASDAQ: AMGN) and ChemoCentryx, Inc., (NASDAQ: CCXI), a biopharmaceutical company focused on orally administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, reported that the companies have entered into a definitive agreement under which Amgen will acquire ChemoCentryx for $52 per share in cash, representing an enterprise value of approximately $3.7 billion (Press release, Amgen, AUG 4, 2022, View Source [SID1234617582]).

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"The acquisition of ChemoCentryx represents a compelling opportunity for Amgen to add to our decades-long leadership in inflammation and nephrology with TAVNEOS, a transformative, first-in-class treatment for ANCA-associated vasculitis," said Robert A. Bradway, chairman and chief executive officer at Amgen. "We are excited to join in the TAVNEOS launch and help many more patients with this serious and sometimes life-threatening disease for which there remains significant unmet medical need. We also look forward to welcoming the highly skilled team from ChemoCentryx that shares our passion for serving patients suffering from serious diseases."

"A fierce commitment to improving human lives is the bond that unites Amgen and ChemoCentryx today," said Thomas J. Schall, Ph.D., president and chief executive officer of ChemoCentryx. "Last year, after 25 years of proud history, we at CCXI delivered on our founding promise with the approval of TAVNEOS for patients with anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis). It is an honor to now join Amgen’s great mission, and together begin a bright new era bringing landscape-shaping medicines like TAVNEOS to those who will benefit most."

TAVNEOS is an orally administered selective complement component 5a receptor inhibitor. It was approved by the U.S. Food and Drug Administration in October 2021 as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis, specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA-associated vasculitis), in combination with standard therapy.

ANCA-associated vasculitis is an umbrella term for a group of multi-system autoimmune diseases with small vessel inflammation. Inflamed vessels may rupture or become occluded giving rise to a broad array of clinical symptoms and signs related to a systemic inflammatory response which may result in profound injury and dysfunction in the kidneys, lungs and other organs.

Amgen is a leader in inflammation and nephrology. The company’s inflammation portfolio includes Otezla, ENBREL, TEZSPIRE, AMGEVITA (a biosimilar to HUMIRA), RIABNI (a biosimilar to Rituxan), and AVSOLA (a biosimilar to REMICADE). Amgen’s pipeline includes four innovative Phase 2 inflammation medicines – efavaleukin alpha for systemic lupus erythematosus and ulcerative colitis, ordesekimab for celiac disease, rocatinlimab for atopic dermatitis and rozibafusap alfa for systemic lupus erythematosus – as well as ABP 654, a biosimilar to STELARA that is in Phase 3 development. Amgen’s nephrology portfolio includes EPOGEN, Aranesp, Parsabiv and Sensipar.

U.S. sales of TAVNEOS in the first quarter of 2022, the first full quarter of sales, were $5.4 million. TAVNEOS is also approved in major markets outside the U.S., including the European Union and Japan. Vifor Fresenius Medical Care Renal Pharma Ltd. will retain exclusive rights to commercialize TAVNEOS outside the U.S., except in Japan where Kissei Pharmaceutical Co., Ltd. holds commercialization rights and Canada where Otsuka Canada Pharmaceutical holds commercialization rights.

In addition to TAVNEOS, ChemoCentryx has three early-stage drug candidates that target chemoattractant receptors in other inflammatory diseases and an oral checkpoint inhibitor for cancer.

The transaction has been unanimously approved by each company’s board of directors. The transaction is subject to ChemoCentryx stockholder approval, regulatory approvals and other customary closing conditions, and is expected to close in the fourth quarter of 2022.

Amgen management will comment further on the ChemoCentryx transaction on its Q2 earnings call today.

PJT Partners acted as financial advisor to Amgen and Wachtell, Lipton, Rosen & Katz is serving as its legal advisor. Goldman Sachs & Co. LLC acted as financial advisor to ChemoCentryx, and Latham & Watkins LLP is serving as its legal advisor.

On August 4, 2022 XOMA Corporation (Nasdaq: XOMA), a biotech royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of advancing novel therapeutic candidates aimed at improving human health, reported its second quarter 2022 financial results and provided a recent operations update (Press release, Xoma, AUG 4, 2022, View Source [SID1234617581]).

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"The assets in our royalty and milestone portfolio made significant progress in the first half of 2022. In the second quarter, Rezolute presented the results from its Phase 2b RIZE clinical study of RZ358 in patients with congenital hyperinsulinism (CHI) at the Pediatric Endocrine Society’s 2022 Annual Meeting. The study results exceeded expectations leading Rezolute to announce its intention to launch a Phase 3 program1. Day One presented initial data from the Pivotal FIREFLY-1 trial of tovorafenib (DAY101) in patients with pediatric low-grade glioma. In its presentations, Day One’s management articulated its Phase 3 clinical trial plan, which is expected to begin in the third quarter of 20222. Both companies raised capital on their respective data to fund the Phase 3 programs3. We look forward to further public announcements from both Rezolute and Day One as children with CHI or low-grade glioma need access to new therapeutic options," stated Jim Neal, Chairman and Chief Executive Officer of XOMA.

"We have had a recent addition to our early clinical-stage assets as Sonnet BioTherapeutics launched Phase 1 development activities for SON-1010, which resulted in our earning a milestone payment. We congratulate all of our partners for their recent successes."

Financial Results
XOMA recorded total revenues of $1.0 million for the second quarter of 2022 and $0.9 million for the second quarter of 2021.

Research and development ("R&D") expenses were $40,000 and $38,000, respectively, for the second quarters of 2022 and 2021.

General and administrative ("G&A") expenses were $5.7 million for the second quarter of 2022, compared to $3.9 million for the second quarter of 2021. The increase of $1.8 million for the three months ended June 30, 2022, as compared to the corresponding period of 2021, was due primarily to a $0.9 million increase in consulting and legal expenses associated with deal costs, $0.4 million increase in personnel related costs, and a $0.2 million increase in executive search fees for XOMA’s new Chief Executive Officer.

In the second quarter of 2022, G&A expenses included $0.8 million in non-cash stock-based compensation expense, which was consistent with the second quarter of 2021. XOMA’s net cash used in operations in the second quarter of 2022 was $4.3 million, as compared with $4.0 million during the second quarter of 2021.

Other income, net was $0.1 million for the second quarter of 2022, compared to other income, net of $1.3 million in the corresponding quarter of 2021. The fluctuation in other income, net between the quarters ended June 30, 2022 and 2021, is primarily due to the change in the fair value of equity securities XOMA holds in Rezolute, Inc.

Net loss for the second quarter of 2022 was $4.7 million, compared to net loss of $2.2 million for the second quarter of 2021.

On June 30, 2022, XOMA had cash of $83.2 million. On July 15, 2022, the Company paid cash dividends on the 8.625% Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) equal to $0.53906 per share and cash dividends on the 8.375% Series B Cumulative Perpetual Preferred Stock (Nasdaq: XOMAO) equal to $0.52344 per depositary share. The Company ended December 31, 2021, with cash and restricted cash of $95.4 million. After paying its remaining debt obligations in the second quarter of 2021, XOMA has no debt on its balance sheet. The Company continues to believe its current cash position will be sufficient to fund XOMA’s operations for multiple years.