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]).

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"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]).

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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]).

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"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]).

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"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.

On March 17, 2022 Advaxis, Inc. (OTCQX: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported its financial results for the first quarter ended January 31, 2022 and provides a business update (Press release, Advaxis, MAR 17, 2022, View Source [SID1234610243]).

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First Quarter Ended January 31, 2022 Financial Results and Recent Key Accomplishments:

Announced that the Company’s common stock would begin trading on the OTCQX Best Market ("OTCQX") on December 23, 2021, under the symbol ADXS
Announced updated clinical data from the Company’s ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA (pembrolizumab)
In Part B of the study, with ADXS-503 as an add on therapy for patients failing KEYTRUDA, a second patient showed partial response (PR), bringing the overall response rate to 15.4% (2/13) and the disease control rate to 46% (6/13). Clinical benefit was durable, with two patients sustaining PR for 23 and 6 months, respectively, while three maintained stable disease (SD) for 15, 6 and 4 months, respectively. Another patient with SD is still under evaluation
Combination therapy was well tolerated with no dose-limiting-toxicity (DLT) or added toxicity of the two drugs
Patients achieving clinical benefit include those with PD-L1 expression ≥50%, secondary resistance disease to KEYTRUDA and those with proliferation and/or activation of NK cells and CD8+ T cells within the initial weeks of therapy
In Part C, with ADXS-503 being dosed in combination with KEYTRUDA, preliminary data show disease control rate of 67% (2/3). The two patients sustained SD for 3 and 11 months, respectively
Announced offering pricing of $5 million of convertible redeemable Series D preferred stock through a private placement
Each share has a purchase price of $4.75, representing an original issue discount ("OID") of 5% of the stated value. The shares of Series D preferred stock are convertible into shares of the Company’s common stock, upon the occurrence of certain events, determined by dividing the $5.00 stated value of a share of preferred stock by the conversion price of $0.25, subject to adjustment
The Series D preferred stockholders may exercise the option to convert the shares at any time following the receipt of the stockholder approval for a reverse stock split
Upcoming milestones
The results of translational studies, including flow cytometry, ELISPOT, cytokine/chemokine levels, mutational analysis, MSI TMB and cfDNA and their clinical correlates, will be presented at an upcoming medical meeting

Management Commentary

"The impressive initial results from our on-going phase 1/2 study suggest that ADXS-503 has the capacity to restore responsiveness to check point inhibitors in patients who were no longer benefiting from these medications," said Kenneth A. Berlin, President, Chief Executive Officer and Interim Chief Financial Officer of Advaxis. "The 15.4% overall response rate is close to the 20% durable response rate that, in the absence of significant toxicity, could lead ADXS-503 to become a new therapeutic option for this underserved population. We look forward to completing the full enrollment of 18 patients in Part B of the study and to the continuing enrollment of first line patients in Part C. In addition, through our careful control of expenses we have extended our cash runway into the second fiscal quarter of 2024."

First Quarter Ended January 31, 2022 Financial Results

Research and development expenses for the first quarter of fiscal year 2022 were $1.7 million, compared with $2.6 million for the first quarter of fiscal year 2021. The reduction of $0.9 million was primarily attributable to the substantial reduction in costs associated with the winding down of clinical studies that have been discontinued. General and administrative expenses for the three months ended January 31, 2022 were approximately $2.5 million, compared to $3.0 million in the same three-month period in 2021. The decrease of $0.5 million primarily relates to decreases in rent and utilities, personnel costs and legal costs, which were partially offset by proxy fees and the abandonment of non-strategic intellectual property.

As of January 31, 2022, the Company had approximately $36.5 million in cash and cash equivalents.