On March 11, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of antibody therapeutics, reported an e-poster presentation featuring nonclinical data of PMC-309 at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, PharmAbcine, MAR 11, 2021, View Source [SID1234576554]). The meeting will take place virtually over April 10-15 and May 17-21 2021.

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Presentation Details
Title: PMC309, a highly selective anti-VISTA antibody enhances T cell activation through blocking the interaction of T cells and myeloid derived suppressor cells (MDSC)
Session category/title: Immunology/Immune Checkpoints
Abstract number: 1116
Poster number: 1626
Presentation Type: E-poster with audio presentation
Date: April 10, 2021

PMC-309 is a novel monoclonal IgG (Immunoglobulin G) targeting human VISTA (V-domain Ig Suppressor of T cell Activation) expressed primarily on MDSC (Myeloid-Derived Suppressor Cells). PMC-309 is one of the company’s first in class immuno-oncology drug candidates. It can provide a promising immunotherapeutic strategy through the inhibition of VISTA-positive immunosuppressive cell activities.

"We are delighted to share the data that validate PMC-309’s unique mode of action and its therapeutic effect in the preclinical setting," said Dr. Jin-San Yoo, CEO of PharmAbcine. "We find the data highly encouraging, and this will give us added confidence in preparing PMC-309 for global Phase I trial in 2022."

On March 11, 2021 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, reported business highlights and financial results for the year ended December 31, 2020 (Press release, Aldeyra Therapeutics, MAR 11, 2021, View Source [SID1234576476]).

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"During the past year, we have worked diligently to advance our lead investigational compound reproxalap into pivotal Phase 3 clinical trials in dry eye disease and allergic conjunctivitis, two of the largest markets in ophthalmology," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "Based on clinical results to date, we believe reproxalap has the potential to be first-line therapy for the treatment of dry eye disease and an important alternative to corticosteroids for the treatment of allergic conjunctivitis. We look forward to the potential to further validate the opportunities for reproxalap with the results of the TRANQUILITY, TRANQUILITY-2, and INVIGORATE trials, as we begin 2021 in a strong financial position, with liquidity expected to fund our current clinical development plans and operations through 2023."

Recent Highlights and Program Updates

Phase 3 INVIGORATE Allergic Conjunctivitis Trial Enrollment Completed: Aldeyra has completed patient enrollment of its randomized, double-masked, crossover design, vehicle-controlled, allergen chamber Phase 3 INVIGORATE Trial of 0.25% reproxalap ophthalmic solution in patients with allergic conjunctivitis. The primary efficacy endpoint is patient-reported ocular itching score assessed on a 9-point scale. Investigator-assessed ocular redness is a key secondary endpoint. Top-line results are expected in the first half of 2021.
Phase 3 TRANQUILITY Dry Eye Disease Trial Design Finalized: In February 2021, Aldeyra announced the finalization of the design of the multi-center, randomized, double-masked, parallel-group, vehicle-controlled Phase 3 TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution for the treatment of dry eye disease. Approximately 150 dry eye disease patients are expected to be enrolled per arm. The primary endpoint is ocular redness over 90 minutes in a dry eye chamber. Tear RASP levels, Schirmer’s Test, and dry eye disease symptoms will be secondary endpoints. The protocol will utilize the two-day dosing paradigm, dry eye challenge design, and enrollment criteria of the run-in cohort. Results from the run-in cohort, announced in January 2021, demonstrated statistically significant improvement of reproxalap over vehicle in eye dryness score and other dry eye disease symptoms after a single day of dosing, and, during exposure to a dry eye chamber, statistically significant improvement of reproxalap over vehicle in eye dryness symptom score, ocular discomfort score, and ocular redness. TRANQUILITY and the confirmatory Phase 3 TRANQUILITY-2 Trial are on schedule to initiate enrollment in the first half of 2021. Top-line results from both trials are expected in the second half of 2021.
Phase 2 Clinical Testing of Novel Orally Administered RASP Inhibitor ADX-629 Initiated: In the fourth quarter of 2020, Aldeyra announced the initiation of Phase 2 proof-of-concept clinical trials of ADX-629, a first-in-class orally administered RASP inhibitor for the treatment of psoriasis, atopic asthma, and COVID-19. The trials are part of a systematic strategy to assess the activity of ADX-629 across different types of systemic inflammatory disease. Top-line results from the trials are expected by the end of 2021.
Enrollment of Phase 3 GUARD Proliferative Vitreoretinopathy Trial of ADX-2191 Continues: Completion of enrollment is expected in 2021 for Part 1 of the Phase 3 GUARD Trial of ADX-2191 (0.8% methotrexate intravitreal injection) for the prevention of proliferative vitreoretinopathy, a rare but serious sight-threatening retinal disease with no approved treatment.
Public Offering Completed: Aldeyra announced the closing of an underwritten public offering of 7,868,421 shares of its common stock at a price of $9.50 per share, including 1,026,315 additional shares of common stock sold pursuant to the full exercise of the underwriters’ option to purchase additional shares. The underwritten offering generated gross proceeds of $74.7 million and net proceeds of $70.0 million after deducting underwriting discounts, commissions, and offering expenses.
Full-Year 2020 Financial Summary

Cash and cash equivalents as of December 31, 2020 were $77.9 million. Based on its current operating plan and including the net proceeds from the underwritten public offering completed in January 2021, Aldeyra believes that existing cash and cash equivalents will be sufficient to fund currently anticipated operating expenses through the end of 2023, including the completion of the Phase 3 TRANQUILITY and TRANQUILITY-2 trials in dry eye disease; the completion of the Phase 3 INVIGORATE trial in allergic conjunctivitis; the Phase 2 clinical trials of ADX-629 in psoriasis, atopic asthma, and COVID-19; and the completion of Part 1 of the adaptive Phase 3 GUARD clinical trial in proliferative vitreoretinopathy.

The net loss for full-year 2020 was $37.6 million, or $1.11 per share, compared with a net loss of $60.8 million, or $2.24 per share, for full-year 2019.

Research and Development (R&D) expenses were $24.7 million for full-year 2020 compared with $44.4 million for full-year 2019. The decrease of $19.7 million in R&D expenses primarily reflected a reduction in clinical research and development expenditures, partially offset by an increase in non-cash compensation costs related to a portion of a contingent acquisition milestone.

Acquired in-process research and development expenses were $1.8 million for full-year 2020 compared with $6.6 million for full-year 2019. The $4.8 million decrease is related to lower in-process research and development expenses associated with the 2019 acquisition of Helio Vision.

General and administrative (G&A) expenses were $10.0 million for full-year 2020 compared with $12.2 million for full-year 2019. The decrease of $2.2 million in G&A expenses primarily reflected lower personnel costs, legal costs, public company costs related to continuing compliance with the Sarbanes Oxley Act of 2002, and miscellaneous administrative costs.

Conference Call & Webcast Information

Aldeyra will host a conference call at 8:00 a.m. ET today to discuss its full-year 2020 financial results. The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 6253616. Due to the expected high demand on our conference provider, please plan to dial in to the call at least 15 minutes prior to the start time.

A live webcast of the conference call will also be available on the Investor Relations page of the company’s website at View Source After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

On March 11, 2021 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle ) technology, reported that management will participate in a fireside chat at the Oppenheimer 31st Annual Healthcare Conference on March 16, 2021 at 8:40 a.m. ET (Press release, Bicycle Therapeutics, MAR 11, 2021, View Source [SID1234576499]). The conference will be held in a virtual meeting format.

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A live webcast of the fireside chat will be accessible in the Investors & Media section of Bicycle’s website at www.bicycletherapeutics.com. An archived replay of the webcast will be available for 90 days following the presentation date.

On March 11, 2021 Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer, reported its financial and operational results for the fourth quarter and fiscal year ended December 31, 2020 (Press release, Sierra Oncology, MAR 11, 2021, View Source [SID1234576515]).

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"We are excited to enter the final phase of patient recruitment for MOMENTUM. Trial enrollment remains on track, and we anticipate closing screening in the first half of the year," said Stephen Dilly, MBBS, PhD, President and CEO of Sierra Oncology. "Two important retrospective analyses from the SIMPLIFY studies were presented in December 2020 at the American Society of Hematology (ASH) (Free ASH Whitepaper). Long-term survival in both JAK inhibitor-naïve and JAK inhibitor-exposed patients highlighted momelotinib’s disease modifying potential, and, efficacy in patients with reduced platelets added to the totality of evidence supporting momelotinib’s unique and differentiated profile.

"We are now looking forward to completing enrollment of our pivotal Phase 3 MOMENTUM study, analyzing and presenting topline data, and preparing internally for commercialization. Results of the MOMENTUM study, combined with the SIMPLIFY data sets, will support future regulatory filings and the potential approval of momelotinib for the treatment of myelofibrosis."

Recent and Upcoming Business Highlights

Pivotal Phase 3 MOMENTUM study is on track to complete enrollment by mid-2021. Top-line data are anticipated in H1 2022
Following top-line data availability, Sierra anticipates filing for regulatory approval of momelotinib in H2 2022
Robust overall survival and sustained efficacy outcome data from the previously completed SIMPLIFY studies presented at American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2020
Long-term safety and dose intensity data presented at European Hematology Association (EHA) (Free EHA Whitepaper) annual meeting in June 2020
Significant executive appointments made in preparation for commercial execution: Chief Executive Officer, Stephen Dilly, Chief Business Officer, Kevin Norrett, General Counsel, Christina Thomson and Chief Regulatory & Technical Operations Officer, William Turner
Amendment to CRT Pioneer Fund agreement for SRA737 allowing for potential future development of the compound
Year End 2020 Financial Results (all amounts reported in U.S. currency)
Research and development expenses were $45.1 million for the year ended December 31, 2020 compared to $53.2 million for the year ended December 31, 2019. The decrease was primarily due to a non-cash charge of $10.5 million that was recognized during the year ended December 31, 2019 pertaining to an obligation to issue common stock and a warrant to Gilead Sciences, Inc. (Gilead) in consideration for meaningfully reduced royalty rates and the elimination of a milestone payment, partially offset by a $1.5 million non-cash charge during the year ended December 31, 2020 to recognize the change in fair value of the securities until their issuance in January of 2020. Also contributing to the decrease was a reduction of $7.6 million in clinical trial, third-party manufacturing, and research and preclinical costs for SRA737 and a $0.9 million decrease in personnel-related and allocated overhead costs for the year ended December 31, 2020. These decreased costs were offset by a $9.4 million increase in clinical trial and development costs related to momelotinib for the year ended December 31, 2020. Research and development expenses included non-cash stock-based compensation of $4.3 million and $3.9 million for the year ended December 31, 2020 and 2019, respectively.

General and administrative expenses were $20.1 million for year ended December 31, 2020, compared to $13.7 million for the year ended December 31, 2019. The increase was due to a $4.9 million increase in personnel-related and allocated overhead costs, including a $3.4 million increase in non-cash stock-based compensation and $1.0 million of severance charges that were primarily related to the resignation of an executive, and an increase of $1.5 million in professional fees primarily relating to pre-commercial planning costs for momelotinib. General and administrative expenses included non-cash stock-based compensation of $5.2 million and $1.8 million for the year ended December 31, 2020 and 2019, respectively.

Total other income (expense), net was $15.8 million of other expense, net for the year ended December 31, 2020, compared to $21.4 million of other expense, net for the year ended December 31, 2019. The difference was primarily attributable to a non-cash charge of $20.9 million recognized during the year ended December 31, 2019, related to the change in fair value of warrant liabilities and $1.3 million of offering expenses pertaining to the issuance of the warrants in the 2019 public offering, offset by a non-cash charge of $16.2 million recognized during the year ended December 31, 2020, related to the change in fair value of warrant liabilities which were reclassified to equity in January 2020.

For the year ended December 31, 2020, Sierra incurred a Generally Accepted Accounting Principles (GAAP) net loss of $80.9 million compared to a GAAP net loss of $88.3 million for the year ended December 31, 2019. The GAAP net loss includes a non-cash charge of $16.2 million and $20.9 million, related to the change in fair value of warrant liabilities, for the year ended December 31, 2020 and December 31, 2019, respectively, and a non-cash charge of $1.5 million and $10.5 million pertaining to the obligation to issue securities to Gilead for the year ended December 31, 2020 and 2019, respectively.

Non-GAAP adjusted net loss was $53.7 million for the year ended December 31, 2020, compared with a non-GAAP adjusted net loss of $51.2 million for the year ended December 31, 2019. Non-GAAP adjusted net loss excludes expenses related to the change in fair value of warrant liabilities, the securities issuance obligation, and stock-based compensation. See "Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below for a reconciliation of this GAAP and non-GAAP financial measure.

Cash and cash equivalents totaled $104.1 million as of December 31, 2020, compared to $147.5 million as of December 31, 2019.

As of December 31, 2020, there were 11,128,484 total shares of common stock outstanding and warrants to purchase 11,102,251 shares of common stock, with an exercise price equal to $13.20 per share. There were 4,146,928 shares issuable upon exercise of stock options and an additional warrant to purchase 1,839 shares.

On March 11, 2021 ITM AG reported that the company will present a poster describing the clinical trial design for its ongoing phase III trial COMPETE for their lead candidate, no-carrier-added Lutetium-177-Edotreotide (n.c.a. 177Lu-Edotreotide), a Targeted Radionuclide Therapy for gastroenteropancreatic neuroendocrine tumors (GEP-NETs), at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting on April 10-15, 2021 and May 17-21, 2021 (Press release, ITM Isotopen Technologien Munchen, MAR 11, 2021, View Source [SID1234576533]).

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The e-poster website will be launched on Saturday, April 10, 2021 at 8.30am ET and will remain available for viewing until Monday, June 21, 2021. Please see below for details on the poster abstract.

Session Category: Phase III Clinical Trials in Progress
Title: COMPETE Phase III Trial – Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide vs. Everolimus in Progressive GEP-NET
Authors: J.R. Strosberg, A. M. Avram, C. Mari Aparici, M. Wahba
Presenter: Mona Wahba, MD, Deputy CMO at ITM
Abstract Number: CT254

COMPETE is an international, prospective, randomized, controlled, open-label, multicenter phase III clinical trial to evaluate efficacy and safety of Targeted Radionuclide Therapy with n.c.a. 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+) neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NETs).