On March 2, 2023 Click Therapeutics, Inc. ("Click"), a leader in Digital Therapeutics as prescription medical treatments, reported that company management will participate in two investor conferences this month (Press release, Click Therapeutics, MAR 2, 2023, View Source [SID1234628099]).

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Cowen 43rd Annual Health Care Conference: March 6-8, 2023 in Boston, MA
Barclays Global Healthcare Conference: March 14-16, 2023 in Miami, FL
Company management will participate in one-on-one meetings at both conferences. To request a meeting with the company, please reach out to the respective conference organizers.

On March 2, 2023 Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, reported financial results for the quarter and full-year ended December 31, 2022 and provided a corporate update (Press release, Syros Pharmaceuticals, MAR 2, 2023, View Source [SID1234628098]).

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"In 2022, we advanced our efforts to develop new standards of care for the frontline treatment of hematologic malignancies, announcing promising data from our ongoing studies in AML and APL and progressing our pivotal trial in HR-MDS," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We believe we are well-positioned to build on this progress in the year ahead. We are also encouraged by the continued momentum in our global enrollment for SELECT-MDS-1. As evidenced by the FDA’s recent decision to grant Fast Track Designation to tamibarotene for HR-MDS, there is a clear need for new therapies that can address the needs of people living with this progressive and devastating disease and we are working with urgency, together with physicians around the world, to recruit and enroll the SELECT-MDS-1 trial. In addition, we have initiated the randomized portion of the SELECT-AML-1 Phase 2 trial and are actively screening patients. We expect to report initial data from SELECT-AML-1 in the fourth quarter of this year and to provide an update on the development path and timing for further evaluation of SY-2101 in a registration-enabling study in APL in the second half of this year."

Dr. Simonian continued, "Following our strategic financing in 2022, we are operating from a position of financial strength, with sufficient capital to fund our efforts into the second quarter of 2025. Importantly, we expect that this capital will bring us beyond Phase 3 data from the SELECT-MDS-1 trial and initial data from the randomized portion of the SELECT-AML-1 trial, while also allowing us to begin investing in the commercial infrastructure that will be necessary to deliver our products to patients."

UPCOMING MILESTONES

Tamibarotene: Higher-Risk Myelodysplastic Syndrome (HR-MDS)

Complete patient enrollment in the SELECT-MDS-1 Phase 3 trial in newly diagnosed HR-MDS patients with RARA gene overexpression in the fourth quarter of 2023.
Report pivotal complete response (CR) data from the SELECT-MDS-1 Phase 3 trial in the third quarter of 2024.
Tamibarotene: Acute Myelodysplastic Syndrome (AML)

Announce initial data from the randomized portion of the SELECT-AML-1 Phase 2 trial in newly diagnosed unfit AML patients with RARA overexpression in the fourth quarter of 2023.
Report additional data from the SELECT-AML-1 Phase 2 trial in 2024.
SY-2101: Acute Promyelocytic Leukemia (APL)

Provide an update on the dose confirmation study of SY-2101, as well as the development path and timing for further evaluation of SY-2101 in a registration-enabling study in APL, in the second half of 2023.
RECENT PIPELINE HIGHLIGHTS

Initiated the randomized portion of the SELECT-AML-1 study and ­­patient screening. The study is designed to evaluate the safety and efficacy of tamibarotene in combination with venetoclax and azacitidine compared to venetoclax and azacitidine in approximately 80 patients with RARA overexpression, randomized 1:1. The primary endpoint is composite complete response (cCR) rate.
In February 2023, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to tamibarotene for the treatment of HR-MDS. Fast Track is a process designed by the FDA to facilitate the development and expedite the review of drugs that have the potential to treat serious conditions and address recognized areas of unmet medical need.
In December 2022, Syros announced the publication in Blood Advances of results from the completed biomarker-directed Phase 2 trial of tamibarotene in combination with azacitidine in newly diagnosed unfit AML patients. In patients with RARA gene overexpression, the combination of tamibarotene and azacitidine demonstrated a cCR rate of 61%, with a rapid onset and clinically meaningful durability. In patients with low blast count AML, the CR rate was 67%. In addition, correlative analyses of RARA expression levels identified an association of RARA overexpression with a monocytic gene expression signature that may be associated with resistance to venetoclax. Together, these data support Syros’ ongoing evaluation of tamibarotene for the treatment of AML and MDS patients with RARA overexpression.
At the 64th American Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2022, Syros presented data from six response-evaluable patients in the safety lead-in portion of the ongoing SELECT-AML-1 Phase 2 trial. Treatment with the triplet combination of tamibarotene, venetoclax and azacitidine in patients with RARA overexpression demonstrated an 83% cCR rate and rapid onset of action, with no evidence of increased toxicity relative to historical data of the venetoclax and azacitidine doublet combination.
In December 2022, Syros also extended the research term under the collaboration agreement with Global Blood Therapeutics (GBT), now a part of Pfizer, for an additional year.
Fourth Quarter and Full Year 2022 Financial Results

Revenues were negative $0.8 million for the fourth quarter of 2022, as compared to $7.8 million in the fourth quarter in 2021. This decrease reflects a cumulative catch-up adjustment of revenue recognized under Syros’ collaboration with GBT as a result of extending the term of the research collaboration by one year. Revenues were $14.9 million for the year ended December 31, 2022, consisting of $13.6 million and $1.3 million from Syros’ collaborations with GBT and Incyte, respectively and $23.5 million for the year ended December 31, 2021.
Research and development expenses were $27.9 million for the fourth quarter of 2022 and $111.9 million for the year ended December 31, 2022, as compared to $26.8 million for the fourth quarter of 2021 and $99.9 million for the year ended December 31, 2021. The increase for the fourth quarter of 2022 compared to the same period in 2021 and the increase for the year ended December 31, 2022 compared to the year ended December 31, 2021 were primarily due to the increase in costs associated with the continued advancement of our clinical programs and employee-related expenses.
General and administrative (G&A) expenses were $7.3 million for the fourth quarter of 2022 and $29.3 million for the year ended December 31, 2022, as compared to $6.4 million for the fourth quarter of 2021 and $23.0 million for the year ended December 31, 2021.
Transaction-related expenses of $9.5 million for the year ended December 31, 2022 primarily consist of incurred costs allocated to the warrants issued in connection with the PIPE financing that were accounted for as liabilities, and severance paid to former Tyme employees following our acquisition of Tyme in September 2022.
For the fourth quarter of 2022, Syros reported a net loss of $4.8 million, or $0.17 per share, compared to a net loss of $23.8 million, or $3.78 per share, for the same period in 2021. For the full year ended December 31, 2022, Syros reported a net loss of $94.7 million, or $7.49 per share, compared to a net loss of $86.6 million, or $13.84 per share, for the same period in 2021.
Cash and Financial Guidance

Cash, cash equivalents and marketable securities as of December 31, 2022 were $202.3 million, as compared with $143.4 million on December 31, 2021.

Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second quarter of 2025, beyond Phase 3 data from the SELECT-MDS-1 trial and initial data from the randomized portion of the SELECT-AML-1 trial.

Conference Call and Webcast

Syros will host a conference call today at 8:30 a.m. ET to discuss these fourth quarter and full year 2022 financial results and provide a corporate update.

To access the live conference call, please dial (888) 575-5167 (domestic) or (416) 764-8687 (international) and refer to conference ID 74534085. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On March 2, 2023 Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, reported participation in the following investor and scientific conferences in March (Press release, Immunic Therapeutics, MAR 2, 2023, View Source [SID1234628097])

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March 9: BioCapital Europe. Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic, will present a company overview at this conference in Amsterdam on March 9, 2023, at 3:20 pm CET as part of the Listed Healthcare Track. Specific details regarding webcast and replay information will be published on the "Events and Presentations" section of Immunic’s website at: View Source, once they are available.

March 17-21: 2023 American Academy of Dermatology (AAD) Annual Meeting. Andreas Muehler, M.D., Chief Medical Officer of Immunic, will attend this conference in New Orleans, Louisiana.

March 28-31: 32nd Annual Meeting of the Society for Virology. Members of Immunic’s preclinical team and its collaboration partners have been accepted to present three posters at this conference in Ulm, Germany. Specific details for the oral and poster presentations will be published on the "Events and Presentations" section of Immunic’s website at: ir.imux.com/events-and-presentations, once they are available.
Poster Presentation: Preclinical Development of Optimized DHODH Inhibitors as Broad-Spectrum Antivirals for the Treatment of Respiratory Virus Infections
Presenting Author: Dr. Alexandra Herrmann, Program Manager Virology, Immunic

Poster Presentation: Characterization of an MPXV Outbreak in Franconia (Bavaria, Germany) and Antiviral Testing of Patient Isolates
Presenting Author: Dr. Arne Cordsmeier, Institute for Clinical and Molecular Virology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany (co-authored by Immunic)

Oral Presentation: Selective Small Molecules Directed to Nuclear Receptor RORγ Isoform 1 Exhibit a Broad Antiviral Potential Through Metabolic Restriction of Virus Replication
Presenting Author: Dr. Friedrich Hahn, Institute for Clinical and Molecular Virology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany (co-authored by Immunic)

On March 2, 2023 The co-founder of Aldevron, Dr. John Ballantyne, reported that it has invested $3M in CureLab Oncology and CureLab Veterinary (Press release, CureLab Oncology, MAR 2, 2023, View Source [SID1234628096]). The two sister companies have developed an anti-cancer and anti-inflammatory drug that was contract-manufactured by Aldevron at the time Dr. Ballantyne served there as chief scientific officer. The investment positions both companies to attain the R&D milestones needed to secure additional rounds of funding.

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Both CureLab Oncology and CureLab Veterinary are developing therapies that employ plasmids (circular DNA encoding a gene called p62/SQSTM1). CureLab Oncology is applying the p62 plasmid to treat human cancers. Following impressive clinical data presented at the European Society for Medical Oncology Congress in Paris, and the considerable ongoing progress of the company’s clinical studies, the funds will enable CureLab Oncology to ramp up toward FDA-monitored clinical trials for triple-negative breast cancer and platinum-resistant ovarian cancer in 2023.

"I have been observing the CureLab journey since Aldevron produced the very first batch of their product. I have witnessed the CureLab team growing and evolving, obtaining patent protection around the world, and keeping an eye on their pre-clinical and clinical progress. The team and the strength of their recent clinical data is what made me want to invest," said Dr. John Ballantyne.

"Distributing Dr. Ballantyne’s investment among the two companies will greatly reduce the R&D risks for both CureLab Oncology and CureLab Veterinary," said Dr. Alexander Shneider, CEO of CureLab Oncology.

The research activities of the two CureLab sister companies are highly synergistic. The data obtained in real-life veterinary settings, in pets, serves as a much stronger predictor for human clinical trials than experiments conducted on laboratory animals. For example, if CureLab Veterinary demonstrates that the product is effective in the treatment of canine osteoarthritis or inflammatory bowel syndrome, both of which are highly prevalent among dogs, CureLab Oncology could extend its clinical programs to treat these pathologies.

For the treatment of domestic animals, CureLab Veterinary received positive clinical results in 10 out of 11 dogs diagnosed with breast cancer. The company is looking to take its patented p62 plasmid technology through the USDA-CVB process with a view to marketing new anti-cancer and anti-inflammatory technologies for use by veterinarians.

"As an industry leader in both thought and action, I am pleased that John has decided to support our efforts to bring innovative animal technology through the US approval process," said Robert Devlin, president of CureLab Veterinary. "Through his generous support, we hope to help many animals and bring joy to pet owners worldwide."

CureLab Veterinary is currently engaged in a crowdfunding effort with Netcapital.

About Elenagen
CureLab’s lead investigational compound is code-named Elenagen, an experimental DNA therapy that consists of a circular piece of DNA called a plasmid that includes a gene for a human protein called p62/SQSTM1. In animal studies and Phase I/II human trials conducted ex-US, Elenagen demonstrated promise in reversing tumor grade, changing the tumor microenvironment, and enhancing the anti-cancer effects of chemotherapy. Experimental results also indicate mitigation of chronic inflammation and stimulation of an immune response to the tumor.

About CureLab Veterinary
Today, our four-legged family members are living longer than ever. Unfortunately, with this longer lifespan, our furry friends now are experiencing many of the same cancers and diseases due to chronic inflammation as their pet parents. CureLab Veterinary, a sister company of CureLab Oncology, is dedicated to bringing advanced therapies to treat cancer and inflammatory diseases to support better pet health and longevity. To learn more, visit curelabveterinary.com.

On March 2, 2023 Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, reported it will be presenting data comparing risk stratification and radiation benefit (RT) for patients with ductal carcinoma in situ (DCIS) using DCISionRT with a clinicopathologic (CP) model similar to the Memorial Sloan Kettering Cancer Center (MSKCC) DCIS nomogram at the 40th Annual Miami Breast Cancer Conference (MBCC), being held on March 2 – 5, 2023 at the Fontainebleau Miami Beach (Press release, PreludeDx, MAR 2, 2023, View Source [SID1234628095]).

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The poster entitled, ‘Comparing Risk Stratification and Radiotherapy Benefit for Patients with DCIS Using a 7-gene Biosignature as Compared to a Clinicopathologic Nomogram’ will be available for viewing during the duration of the conference and available during the in-person poster receptions on March 2nd and 3rd. The study included 926 DCIS patients from four cohorts who were treated with breast conserving surgery (BCS) or BCS + radiation therapy (RT). The study compared MSKCC DCIS nomogram-like model with the DCISionRT 7-gene biosignature.

DCISionRT re-classified nearly two-thirds of patients in the Low-Risk MSKCC nomogram-like group as Elevated Risk, which had elevated 10-yr IBR rates and an 80% relative benefit from RT.

"It is important for clinicians to follow the clinical evidence to enable the best treatment decisions for their patients," said Julie Margenthaler, MD, FACS, Siteman Cancer Center, Washington University School of Medicine. "In this study, we demonstrated the ability of DCISionRT to better risk-stratify DCIS patients following BCS and identify patients with low-risk CP who may benefit from RT, avoiding potential undertreatment."

"Previously we were limited to clinicopathologic criteria, such as nomograms, to guide DCIS treatment decisions," said Chirag Shah, MD, Co-Director of Comprehensive Breast Program and Director of Clinical Research in the Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic Cleveland OH. "DCISionRT provides us the clinical evidence to identify which DCIS patients, despite having low-risk clinicopathologic features, can actually benefit from RT and which patients may safely omit RT."

"We are pleased to share our latest data demonstrating the clinical significance of DCISionRT," says Dan Forche, President and CEO of PreludeDx. "We have been able to consistently demonstrate that the integration of DCISionRT into clinical decision processes has substantial impact on recommendations aimed at optimal patient management to prevent over-or under treatment of DCIS patients."

Additional MBCC Poster Presentations Include:

Posters will be available for viewing during the duration of the conference and available during the in-person poster receptions on March 2nd and 3rd.

Characterization of Recurrence Risk After Lumpectomy and Radiotherapy in HER2-Positive Ductal Carcinoma In Situ of the Breast Using a 7-gene Predictive Biosignature: Implications for the NSABp-B43 Trial Results

A 7-Gene Predictive Biosignature Improves Risk Stratification for Breast Ductal Carcinoma in Situ Patients Compared to Clinicopathologic Criteria, Identifying a Low Risk Group Not Clinically Benefiting from Adjuvant Radiotherapy

Changes in Treatment Recommendation for Patients with Ductal Carcinoma In Situ Using a 7-gene Predictive Biosignature: Analysis of the PREDICT Study

The PREDICT study is a prospective, multi-institutional registry for patients who received DCISionRT testing as part of their routine care. The registry includes females 26 and older who are diagnosed with DCIS and are candidates for BCS and eligible for RT. The analysis demonstrates RT recommendations to add or omit RT based on the 7-gene predictive biosignature in 2,308 patients was changed in 38% of women after testing and hormonal treatment (HT) recommendations was changed in 11%.

About DCISionRT for Breast DCIS

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with risk-based assessment scores to assess a woman’s individual tumor biology along with other pathologic risk factors and provide a personalized recurrence risk. The test provides a Decision Score that identifies a woman’s risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.