On March 17, 2022 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported the appointment of Joseph Todisco as Chief Executive Officer of the company (Press release, CorMedix, MAR 17, 2022, View Source [SID1234610254]). Mr. Todisco also will join the CorMedix Board of Directors. The company expects Mr. Todisco to join CorMedix on May 16th or such earlier date as he completes his contractual responsibilities to his current employer.

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!

Myron Kaplan, Chairman of CorMedix’s Board of Directors commented, "We are delighted to welcome Joe to CorMedix as the new Chief Executive Officer. Having built pharmaceutical businesses in the past and led successful commercial organizations globally, Joe brings significant and relevant experience to the company. The Board believes he is the right person to lead CorMedix as we continue to advance DefenCath and aim to build a successful commercial franchise around our lead product. The Board also is grateful for Dr. Matt David’s leadership throughout the interim period and we look forward to continuing to work with him and the executive team."

"CorMedix has a strong late-stage pre-commercial asset in DefenCath with a compelling value proposition for patients in the hemodialysis community," said Mr. Todisco. "I am excited to be taking on this role, and I look forward to working alongside the CorMedix board, management, and employees to continue building the company as we prepare for a potential commercial launch in hemodialysis and explore new opportunities for growth."

"With the recent announcement of our resubmission of the DefenCath NDA to the FDA, the CorMedix team has been active on all fronts as we have worked through manufacturing challenges and continued to build our understanding of the commercial opportunity for DefenCath," said Dr. Matt David, interim CEO and Chief Financial Officer. "I join my colleagues in welcoming Joe to CorMedix as Chief Executive Officer. I look forward to working closely with Joe as we seek to transform CorMedix to a commercial stage entity."

Joe Todisco is an experienced pharmaceutical industry leader with a track record of building businesses globally and providing commercial leadership over the last 20 years. Previously, Mr. Todisco was a senior executive at Amneal Pharmaceuticals, where for the past 11 years he has held various roles, most recently as Executive Vice President, Chief Commercial Officer where he was responsible for Amneal Specialty, a growing branded products business with $380 million in revenue and approximately 200 employees. During his tenure at Amneal, Mr. Todisco held roles overseeing corporate development and international operations, leading commercial teams in several international markets including the UK, Australia and Germany, as well as leading Amneal’s merger integration with Impax Laboratories in 2018.

Mr. Todisco was previously Co-Founder and managing executive of Gemini Laboratories, a specialty pharmaceutical company focused on the sales and marketing for niche branded products in the US Market. Gemini Laboratories was established as an affiliate of Amneal Pharmaceuticals and was subsequently acquired by Amneal in 2018.

Prior to joining Amneal, Mr. Todisco was Vice President, Business Development & Licensing at Ranbaxy, Inc. where he was responsible for developing and executing Ranbaxy’s North American commercial business strategy. Prior to Ranbaxy, he held various roles at Par Pharmaceutical, and in his earlier career held positions at Oppenheimer & Company and Marsh & McLennan Companies. Mr. Todisco obtained his MBA in finance from Fordham Graduate School of Business and his BA in Economics from Georgetown University.

On March 17, 2022 Century Therapeutics, Inc., (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported financial results and business highlights for the fourth quarter and year ended December 31, 2021 (Press release, Century Therapeutics, MAR 17, 2022, View Source [SID1234610253]).

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!

"Throughout 2021, we continued to make steady progress in developing our comprehensive, next-generation iPSC-based cell therapy platform, executed on our powerful discovery engine, and we believe we are positioned to transition to a clinical stage company in 2022. With this foundation in place, we are on track to advance multiple product candidates to the clinic over the next three years," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "Additionally, we look forward to continuing our partnership in the years ahead with Bristol Myers Squibb, a global leader in oncology and hematology, to further expand our pipeline of iPSC-derived cell therapy products for treating hematological and solid tumor malignancies. We are committed to maximizing the potential utility of our platform technology and look forward to what we expect to be a very productive year ahead."

Business Highlights

Entered into a collaboration and license agreement with Bristol Myers Squibb in January 2022 to develop and commercialize up to four iPSC-derived, engineered natural killer cell (iNK) and / or T cell (iT) programs for hematologic malignancies and solid tumors. Under the terms of the agreement, Century received a $100 million upfront payment and Bristol Myers Squibb made a $50 million equity investment in Century Therapeutics’ common stock. The agreement provides for future program initiation fees and development, regulatory, and commercial milestone payments totaling more than $3 billion plus royalties on product sales.
Announced that, subject to U.S. Food and Drug Administration (FDA) acceptance of its Investigational New Drug (IND) application, the Company plans to initiate a Phase 1 trial, ELiPSE-1, to assess CNTY-101 in patients with relapsed/refractory aggressive lymphoma or indolent lymphoma after at least two prior lines of therapy, including patients who have received prior CAR T cell therapy. In vivo data presented at the Annual Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December demonstrated strong antitumor activity against human lymphoma cell lines with CNTY-101.
Announced plans to focus its initial T cell development program on γδ cells. Data presented at the ASH (Free ASH Whitepaper) Annual Meeting in December suggest that γδ CAR-iT cells provide an opportunity to deliver allogeneic T cell therapies without risk for graft-versus-host disease. CNTY-102 will be a CAR- γδ iT candidate targeting CD19, and a second antigen for relapsed/refractory B cell lymphoma and other B cell malignancies.

Added to the NASDAQ Biotechnology Index (NASDAQ: NBI) in December 2021.
Upcoming Milestones

Current Good Manufacturing Practice (cGMP) manufacturing facility expected to be operational in 2022.
CNTY-101 IND filing remains on track for mid-2022. Subject to U.S. FDA acceptance of its IND application, the Company plans to initiate the Phase 1 ELiPSE-1 trial of CNTY-101 in relapsed/refractory lymphoma in 2022.
Expect to submit an IND for CNTY-103 in 2023. CNTY-103 is Century’s first solid tumor candidate for glioblastoma.
Fourth Quarter and Year-end 2021 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $358.8 million as of December 31, 2021, as compared to $76.8 million as of December 31, 2020. Net cash used in operations was $89.0 million for the twelve months ended December 31, 2021, compared to $41.3 million for the twelve months ended December 31, 2020.
Research and Development (R&D) expenses: R&D expenses were $75.6 million for the year ended December 31, 2021, compared to $39.7 million for the year ended December 31, 2020. The increase in R&D expenses was primarily due to an increase in personnel expenses related to increased headcount to expand the Company’s R&D capabilities, costs for preclinical studies, costs for laboratory supplies, and facility costs.
General and Administrative (G&A) expenses: G&A expenses were $19.2 million for the year ended December 31, 2021, compared to $9.5 million for the year ended December 31, 2020. The increase was primarily due to an increase in personnel related expense due to an increase in employee headcount and an increase in the Company’s professional fees as a result of expanded operations to support its infrastructure as well as additional costs to operate as a public company.
Net loss: Net loss was $95.8 million for the year ended December 31, 2021, compared to $53.6 million for the year ended December 31, 2020.
Financial Guidance

The Company expects full year GAAP Operating Expenses to be between $155 million and $165 million including non-cash stock-based compensation expense of $10 million to $15 million.
The Company expects its cash, cash equivalents, and marketable securities, including proceeds from the Bristol Myers Squibb collaboration agreement, will support operations into 2025.

On March 17, 2022 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the Company will present at the 2022 Virtual Growth Conference, hosted by M-Vest, a division of Maxim Group LLC, on March 28th – 30th from 9:00 am – 5:00 pm EDT (Press release, Anixa Biosciences, MAR 17, 2022, View Source [SID1234610247]).

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!

During this virtual conference, Anixa’s Chief Operating Officer and Chief Financial Officer, Mike Catelani, will provide an overview of Anixa’s business and an update on the Company’s programs. To attend the conference and view the presentation, sign up to become an M-Vest member here.

On March 17, 2022 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported financial results for the fourth quarter and year ended December 31, 2021 (Press release, Alpine Immune Sciences, MAR 17, 2022, View Source [SID1234610245]).

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!

"2021 was a period of significant growth at Alpine with the advancement of all three of our clinical programs into significant stages of development," said Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. "As a result we secured $176 million in additional capital through a PIPE financing, the achievement of milestones as part of our AbbVie collaboration and an upfront payment from our recently announced discovery partnership with Horizon Therapeutics."

Dr. Gold added: "2022 looks to be a transformative year for Alpine with several important readouts anticipated across our programs, including the completion of dose escalation for davoceticept monotherapy and initiation of expansion cohorts; as well as the completion of the phase 1 healthy volunteer study for ALPN-303 and initiation of one or more patient-based studies in autoantibody-related diseases by the end of the year."

Full Year 2021 and Recent Clinical and Corporate Updates

Davoceticept (ALPN-202): Conditional CD28 costimulator and dual checkpoint inhibitor
Davoceticept monotherapy dose escalation data (NEON-1) will be presented in an oral presentation at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 12, 2022. Initial findings of davoceticept’s tolerability and clinical activity were previously reported in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
NEON-1 monotherapy expansion cohorts in patients with cutaneous melanoma and PD-L1+ tumors projected to be initiated in the first half of 2022.
Announced partial clinical hold on the NEON-2 trial combining davoceticept with pembrolizumab. Participants previously enrolled can continue to receive davoceticept and pembrolizumab; the NEON-1 monotherapy trial was not affected.
ALPN-303: Dual APRIL/BAFF inhibitor
Began a first-in-human, phase 1 study of ALPN-303 in healthy volunteers in the fourth quarter of 2021; initial safety, pharmacokinetic, and pharmacodynamic findings anticipated by mid-2022.
Preclinical data, highlighting the differentiation and potential best-in-class profile of ALPN-303, were presented in two oral presentations at the European Alliance of Associations for Rheumatology and American College of Rheumatology Convergence 2021 meetings.
Plan to initiate studies in systemic lupus erythematosus (SLE) and potentially additional autoantibody-related diseases in the second half of 2022.
Acazicolcept (ALPN-101): Dual CD28/ICOS inhibitor
Received $45 million in pre-option exercise development milestones as part of the Option and License Agreement with AbbVie, bringing total upfront and milestone payments received through December 31, 2021, to $105 million.
Continue to enroll Synergy, a phase 2 trial of acazicolcept in patients with SLE.
With collaborators at the French National Institute of Health and Medical Research (INSERM), demonstrated that acazicolcept decreased manifestations of systemic sclerosis in preclinical mouse models (Arthritis Res Ther 24: 13, 2022)
General Corporate
Announced an exclusive license and collaboration agreement with Horizon Therapeutics plc for the development and commercialization of up to four preclinical candidates generated from Alpine’s unique discovery platform, which included $40 million in upfront payments ($25 million cash and $15 million equity investment at a 25% premium to the 30-day volume-weighted average share price) and eligibility to receive up to $1.5 billion in total, through future milestone-based payments.
Raised $91 million in a private placement, led by Frazier Life Sciences Public Fund with participation from Decheng Capital, BVF Partners, TCG X, Avidity Partners, OrbiMed, Omega Fund, and Logos Capital, among others.
Fourth Quarter and Full Year 2021 Financial Results

As of December 31, 2021, we had cash, cash equivalents, and investments totaling $215.4 million. Net cash used in operating activities for the year ended December 31, 2021 was $15.2 million compared to net cash provided by operating activities of $30.1 million for the year ended December 31, 2020. The Company recorded net losses of $50.3 million and $27.9 million for the years ended December 31, 2021 and 2020, respectively.

Collaboration revenue for the fourth quarter ended December 31, 2021 was $4.5 million compared to $5.6 million for the fourth quarter ended December 31, 2020. Collaboration revenue for the year ended December 31, 2021 was $23.4 million compared to $9.3 million for the year ended December 31, 2020. The amounts were primarily attributable to the revenue recognized under our AbbVie Agreement.

Research and development expenses for the fourth quarter ended December 31, 2021 were $15.4 million compared to $9.1 million for the fourth quarter ended December 31, 2020. Research and development expenses for the year ended December 31, 2021 were $58.7 million compared to $27.2 million for the year ended December 31, 2020. The increases were primarily attributable to our Synergy and NEON studies, contract manufacturing and process development of our product candidates primarily for acazicolcept and ALPN-303, increased personnel costs and other direct research activities.

General and administrative expenses for the fourth quarter ended December 31, 2021 were $4.5 million compared to $3.0 million for the fourth quarter ended December 31, 2020. General and administrative expenses for the year ended December 31, 2021 were $14.6 million compared to $10.9 million for the year ended December 31, 2020. The increase was primarily attributable to increases in professional and legal services and personnel costs.

The Company expects that its current cash resources, combined with the $25 million up-front payment received from Horizon in January 2022 and the potential $30 million in pre-option exercise milestones payable under its option and license agreement with AbbVie, for the development and commercialization of acazicolcept, will be sufficient to fund its planned operations into 2024.

On March 17, 2022 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company discovering and developing innovative therapies for the treatment of immune-mediated diseases, reported recent corporate highlights and financial results for the year ended December 31, 2021 (Press release, Aldeyra Therapeutics, MAR 17, 2022, View Source [SID1234610244]).

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!

"In addition to our planned completion of clinical development for reproxalap in dry eye disease, 2022 is expected to highlight data milestones for our systemic and retinal disease platforms," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer. "We are excited about the planned release this month of top-line data from our proof-of-concept clinical trials of ADX-629, a first-in-class RASP modulator, across a variety of systemic inflammatory diseases, and we look forward to reporting results of our recently initiated clinical trial of ADX-2191 in retinitis pigmentosa in the second half of this year."

Recent Corporate Highlights

Initiated Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa. Aldeyra initiated a Phase 2 clinical trial of ADX-2191 (intravitreal methotrexate 0.8%), an investigational new drug product, in retinitis pigmentosa, a rare, sight-threatening retinal disease with no approved therapy. The trial is being conducted at Duke University Medical Center.
Reported Positive Results from Phase 2 Dry Eye Chamber Clinical Trial of Reproxalap Compared to Xiidra. In a Phase 2 dry eye chamber clinical trial, ocular discomfort and ocular itching symptom scores were assessed following treatment with either reproxalap or Xiidra (lifitegrast ophthalmic solution 5%). Both ocular discomfort (p=0.002) and ocular itching (p=0.01) were statistically lower after treatment with reproxalap than with Xiidra.
Reported Results from Phase 3 TRANQUILITY Trial of Reproxalap in Dry Eye Disease. Although the primary endpoint of ocular redness was not met in the TRANQUILITY Trial, statistical significance (p=0.0001) was achieved for the dry eye disease sign of Schirmer test, a secondary endpoint. The Schirmer test has been accepted by the U.S. Food and Drug Administration as an approvable objective sign that can be used to support a New Drug Application (NDA) for dry eye disease.
Continued Enrollment in Phase 3 TRANQUILITY-2 Trial of Reproxalap. Patient enrollment continued in the Phase 3 TRANQUILITY-2 Trial of reproxalap in dry eye disease. The primary endpoint of the trial will be met if either Schirmer test or ocular redness achieves statistical significance in favor of reproxalap over vehicle.
Completed Enrollment in Part 1 of Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy. Patient enrollment concluded in Part 1 of the Phase 3 GUARD Trial of ADX-2191 in patients with proliferative vitreoretinopathy, a rare, sight-threatening retinal disease with no approved therapy.
Initiated Enrollment in Phase 3 INVIGORATE-2 Trial of Reproxalap in Allergic Conjunctivitis. Patient enrollment began in the Phase 3 INVIGORATE-2 Trial of reproxalap in allergic conjunctivitis. The protocol of INVIGORATE-2 is substantially identical to that of the Phase 3 INVIGORATE Trial, which, relative to vehicle, demonstrated statistically significant reductions in patient-reported ocular itching (p<0.0001) and investigator-assessed ocular redness (p<0.0001) following treatment with reproxalap in an allergen chamber. Results from INVIGORATE-2 are expected in 2023.
Announced the Publication of Phase 2 Clinical Trial of Reproxalap in Allergen Chamber Model. The peer-reviewed journal Clinical Ophthalmology published results from the randomized, double-masked, vehicle-controlled, crossover Phase 2 clinical trial of reproxalap versus vehicle in an allergen chamber model. Relative to vehicle, reproxalap treatment statistically reduced patient-reported ocular itching (p<0.0001), patient-reported ocular tearing (p<0.0001), and investigator-assessed ocular redness (p<0.0001).
Upcoming Planned Clinical and Regulatory Milestones

Systemic Disease: Top-line data from the Phase 2 proof-of-concept trials of ADX-629 in psoriasis, asthma, and COVID-19 are expected by the end of March 2022.
Dry Eye Disease: Results from the Phase 3 TRANQUILITY-2 Trial of reproxalap in dry eye disease are expected mid-2022, followed by NDA submission, pending the outcome of TRANQUILITY-2 and enrollment in the 12-month safety trial of reproxalap in dry eye disease patients.
Retinal Disease: Results from Part 1 of the Phase 3 GUARD Trial of ADX-2191 in proliferative vitreoretinopathy, and from the Phase 2 clinical trial of ADX-2191 in retinitis pigmentosa, are expected in the second half of 2022.
Full-Year 2021 Financial Results

Cash and cash equivalents as of December 31, 2021 were $229.8 million. Based on its current operating plan, Aldeyra believes that existing cash and cash equivalents will be sufficient to fund currently projected operating expenses through the end of 2023, including potential NDA submissions; initial commercialization of reproxalap, if approved; and continued development of Aldeyra’s product candidates in ocular and systemic immune-mediated diseases.

Net loss for the year ended December 31, 2021 was $57.8 million, or $1.07 per share, compared with a net loss of $37.6 million, or $1.11 per share, for the comparable period of 2020. Losses have resulted from the costs of clinical trials and research and development programs, as well as from general and administrative expenses.

Research and development expenses for the year ended December 31, 2021 were $44.9 million, compared with $24.7 million for the same period in 2020. The increase of $20.2 million is primarily related to increases in clinical research and development expenditures.

General and administrative expenses for the year ended December 31, 2021 were $11.3 million, compared with $10.0 million for the same period in 2020. The increase of $1.3 million is primarily due to increases in legal, insurance, and consulting costs.

Total operating expenses for the year ended December 31, 2021 were $56.2 million, compared with total operating expenses of $36.4 million for the same period in 2020.

Conference Call & Webcast Information

Aldeyra will host a conference call at 8:00 a.m. ET today to discuss recent corporate highlights and financial results for the year ended December 31, 2021. The dial-in numbers are (844) 200-6205 for domestic callers and (929) 526-1599 for international callers. The access code is 132077. Due to expected high demand, please dial in at least 15 minutes prior to the start time.

A live webcast of the conference call can be accessed via the Investors & Media page of the Aldeyra website at View Source After the live webcast, the event will remain archived on the website for 90 days.