On November 8, 2021 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and companion diagnostic strategy for treating patients with cancer, reported financial results for the third quarter ended September 30, 2021 and summarized recent business progress (Press release, Celcuity, NOV 8, 2021, View Source [SID1234595207]).

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"We made great progress advancing our gedatolisib program this past quarter. We initiated preparation for a Phase 3 clinical trial evaluating gedatolisib in combination with Ibrance and Faslodex in patients with ER+/HER2- advanced or metastatic breast cancer that we expect to activate in the first half of 2022," said Brian Sullivan, CEO and co-founder of Celcuity. "Site identification and feasibility activities are underway. We are excited to have the opportunity to present updated results from our Phase 1b clinical trial in patients with ER+/HER2- advanced breast cancer at the San Antonio Breast Cancer Symposium in December. Finally, we are pleased to have entered into another clinical trial collaboration to evaluate CELsignia selected patients with advanced breast cancer. The collaboration with University of Rochester Wilmot Cancer Center and Puma represents an important opportunity to identify a potential new treatment for patients with breast cancer that has metastasized to the brain."

Third Quarter 2021 Business Highlights and Other Recent Developments

Completed transfer of regulatory, clinical trial, and safety reporting responsibilities for gedatolisib from Pfizer to Celcuity ahead of schedule.

Updated data from Celcuity’s ongoing Phase 1b clinical trial for patients with ER+/HER2- advanced breast cancer will be presented at the San Antonio Breast Cancer Symposium during a Spotlight Poster Discussion Session on December 10, 2021. Rachel M. Layman, MD, an oncologist at the University of Texas MD Anderson Cancer Center who was a principal investigator for the clinical trial, will be the presenting author.

Celcuity entered into a clinical trial collaboration agreement with the University of Rochester Wilmot Cancer Center and Puma Biotechnology in October 2021. This single arm Phase 2 trial will evaluate the efficacy and safety of Puma’s pan-HER inhibitor, NERLYNX (neratinib), and capecitabine, a chemotherapy, in patients selected with Celcuity’s CELsignia HER2 Activity Test who have metastatic HER2-negative breast cancer that has progressed on prior treatments. Based on estimates of patient enrollment rates, Celcuity expects to obtain interim results 12 to 15 months after initiation of the trial followed by the final results 12 to 15 months later. Enrollment is planned to begin by mid-2022.

Enrollment in the FACT-1 and FACT-2 trials that are evaluating CELsignia selected patients who have early-stage ER+/HER2- breast cancer was negatively impacted by COVID-19 related delays during the third quarter. Hospitalizations of patients with COVID-19 increased dramatically during this period which led hospitals to reduce clinical trial related activities. Interim results are now expected to be available in the second half of 2022.

Third Quarter 2021 Financial Results

Unless otherwise stated, all comparisons are for the third quarter ended September 30, 2021, compared to the third quarter ended September 30, 2020. The following discussion should be read in conjunction with our unaudited condensed consolidated financial statements and related notes on Form 10-Q for the third quarter ended September 30, 2021.

Total operating expenses were $5.6 million for the third quarter of 2021, compared to $2.5 million for the third quarter of 2020.

Research and development (R&D) expenses were $5.0 million for the third quarter of 2021, compared to $2.0 million for the third quarter of 2020. The increase in R&D expenses during the third quarter of 2021 compared to the prior year primarily resulted from costs associated with the development of gedatolisib. Employee related expenses, including consulting fees, accounted for $1.1 million of the increase. The remaining increase of $1.9 million in expenses is related to clinical trials, patent legal fees, and costs associated with the transfer of the gedatolisib-related activities from Pfizer to Celcuity.

General and administrative (G&A) expenses were $0.6 million for the third quarter of 2021, compared to $0.5 million for the third quarter of 2020. The increase in the third quarter of 2021 arose primarily from non-cash stock-based compensation.

Net loss for the third quarter of 2021 was $6.0 million, or $0.41 loss per share, compared to a net loss of $2.5 million for the third quarter of 2020, or $0.24 loss per share. The Non-GAAP adjusted net loss for the third quarter of 2021 was $5.1 million compared to a non-GAAP adjusted net loss of $2.0 million for the third quarter of 2020. Non-GAAP adjusted net loss excludes stock-based compensation expense, issuance of common stock and non-cash interest. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles (GAAP) in the United States to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the third quarter of 2021 was $4.0 million, compared to $1.6 million for the third quarter of 2020.

At September 30, 2021, Celcuity had cash and cash equivalents of $90.4 million, compared to cash and cash equivalents of $11.6 million at December 31, 2020.

Anticipated Milestones

Celcuity expects to achieve the following potential milestones over the next twelve months:

Obtain formal feedback from the FDA on the design of its proposed Phase 3 clinical trial by early 2022.

Initiate a Phase 3 clinical trial to evaluate gedatolisib in combination with Ibrance and Faslodex in patients with ER+/HER2- advanced breast cancer in the first half of 2022, subject to the FDA feedback.

Provide an update on lifecycle development priorities for gedatolisib in the first half of 2022.

Obtain interim results from the FACT-1 and FACT-2 trials in the second half of 2022.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the third quarter financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial (877) 407-0784 and international callers should dial (201) 689-8560. A live webcast presentation can also be accessed using this weblink: https://78449.themediaframe.com/dataconf/productusers/vvdb/mediaframe/46959/indexl.html. A replay of the webcast will be available on the Celcuity website following the live event.

On November 8, 2021 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported it plans to report third quarter financial results and provide a corporate update on Friday, November 12, 2021, via press release, prior to the market open (Press release, NexImmune, NOV 8, 2021, View Source [SID1234594956]).

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The press release will be accessible under the investor section of the NexImmune’s website at www.neximmune.com.

On November 8, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported the closing of its public offering on 08 November 2021 in the United States of 20,000,000 American Depositary Shares ("ADSs"). Each ADS represents half of one ordinary share of Evotec (Press release, Evotec, NOV 8, 2021, View Source [SID1234594856]). All ADSs sold in the offering were offered by Evotec at a public offering price of $ 21.75 per ADS.

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On 05 November 2021, BofA Securities and Morgan Stanley, as representatives of the several underwriters, notified Evotec of the underwriters’ partial exercise of their option to purchase up to 3,000,000 additional ADSs, representing 1,500,000 ordinary shares (the "Option") at the price of $ 21.75 per ADS. The Option is expected to close on 15 November 2021 and is subject to customary closing conditions.

In total, Evotec expects the gross proceeds of the transaction to amount to $ 500 million comprising the base offering of 20,000,000 ADSs ($ 435 million) and, upon closing, the exercised Option to purchase 2,995,000 additional ADSs ($ 65 million), before deducting underwriting commissions and estimated offering expenses payable by Evotec.

Evotec’s ordinary shares are listed on the regulated market of the Frankfurt Stock Exchange in Germany with additional admission obligations of the Prime Standard Segment.

BofA Securities and Morgan Stanley acted as lead joint book-running managers for the public offering. Citigroup, Jefferies, Cowen, and RBC Capital Markets also acted as joint book-running managers for the offering. The ADSs will be issued under Evotec’s revised ADS program, which continues to be administered by JP Morgan Chase Bank, N.A.

A registration statement relating to the ADSs sold in this offering was filed with the U.S. Securities and Exchange Commission and declared effective on 03 November 2021. The offering was made through a prospectus. Copies thereof may be obtained from BofA Securities, NC1-004-03-43; 200 North College Street, 3rd Floor, Charlotte,

North Carolina 28255-0001, Attention: Prospectus Department or by email at [email protected], Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities law of any such state or Jurisdiction.

This communication and the information contained herein is made solely for information purposes only and does not constitute or form part of a prospectus or any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any securities of Evotec, in any jurisdiction. Neither this communication, nor any part of it, nor the fact of its distribution, shall form the basis of, or be relied on in connection with, any contractual commitment or investment decision in relation to the securities of Evotec, in any jurisdiction, nor does it constitute a recommendation regarding any such securities.

The placement of the securities mentioned in this communication is directed only at persons in member states of the European Economic Area (the "EEA") who are "Qualified Investors" within the meaning of the Prospectus Regulation EU 2017/1129 ("Prospectus Regulation") ("Qualified Investors"). Any person in the EEA who acquires the securities in any offer (an "Investor") or to whom any offer of the securities is made will be deemed to have represented and agreed that it is a Qualified Investor.

In the United Kingdom, this communication is only directed at persons who are "qualified investors" within the meaning of Article 2 of the Prospectus Regulation as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 who are also (i) investment professionals falling within Article 19(5) of the UK Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or (ii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2) of the Order (all such persons together being referred to as "Relevant Persons"). Any investment or investment activity to which this communication relates is available only to Relevant Persons in the United Kingdom and will only be engaged with such persons. Any person in the United Kingdom who is not a Relevant Person should not act or rely on this communication or any of its contents.

On November 8, 2021 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that it has been granted a Pediatric Investigation Plan (PIP) product-specific waiver from the Medicines and Healthcare products Regulatory Agency (MHRA) for HyBryte (SGX301 or synthetic hypericin), which has successfully concluded a Phase 3 pivotal clinical study for the treatment of early stage cutaneous T-cell lymphoma (CTCL) (Press release, Soligenix, NOV 8, 2021, View Source [SID1234594827]).

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The waiver was provided for all subsets of the pediatric population from birth to less than 18 years of age on the grounds that clinical studies in this rare population are not feasible. Earlier this year the European Medicines Agency (EMA) also granted a waiver to the Pediatric Investigational Plan requirements for the European Union (EU). With the withdrawal of the United Kingdom (UK) from the EU effective January 1, 2021, the MHRA became the UK’s standalone medicines and medical devices regulator.

"This achievement is an important regulatory milestone as we move forward with marketing applications worldwide," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "The PIP waiver allows us to work towards advancing a marketing authorization application (MAA) in the UK in a more cost-effective manner since we will not need to expend resources to conduct a pediatric clinical study."

About HyBryte

HyBryte (SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light 16 to 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte has received orphan drug and fast track designations from the U.S. Food and Drug Administration, as well as orphan designation from the EMA.

The Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 patients received HyBryte treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte treatment in the first cycle was safe and well tolerated.

In the second open-label treatment cycle (Cycle 2), all patients received HyBryte treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment groups also revealed a statistically significant improvement (p<0.0001) between the two groups, indicating that continued treatment results in better outcomes. HyBryte continued to be safe and well tolerated. Additional analyses also indicated that HyBryte is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular.

The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received HyBryte throughout all 3 cycles of treatment, 49% of them demonstrated a treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.

Overall safety of HyBryte is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period. Its mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. HyBryte potentially represents the safest available efficacious treatment for CTCL. With no systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.

The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II Small Business Innovation Research (SBIR) grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.

About Cutaneous T-Cell Lymphoma (CTCL)

CTCL is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the U.S., with approximately 3,000 new cases seen annually.

On November 8, 2021 xCures reported the release of xDECIDE, the latest in the company’s suite of tools to empower oncologists and their teams to identify the most suitable, personalized treatment options for advanced cancer patients more efficiently (Press release, xCures, NOV 8, 2021, View Source [SID1234594826]). Through xDECIDE, providers may add patients and review their cases via a consolidated platform, saving them time while ensuring and supporting robust consideration of potential treatment options.

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Whether working in a community setting or in larger institutions, oncologists typically struggle to keep up with their caseloads. Individual case review and treatment options research are time-consuming tasks, and no corners can be cut. xDECIDE’s goal is to save oncologists and their staff members a significant amount of that time by leveraging xCures’ core technology to expedite case preparation and research, including record collection, standardization, structuring, and expert interpretation of the records. The result is that when patients arrive for a visit (and/or return for future visits), both provider and patient are assured by the mutual understanding of the patient’s case history. Also reassuring is the fact that expert research has been conducted and presented for discussion and that all possible options have been evaluated.

xCures’ insights are generated for registered patients by two deliverables: a Cancer Journey and a Treatment Options Report. The patient’s Cancer Journey is a visual overview of their case history, assembled from source medical records compiled seamlessly from all institutions where the patient has received prior care. The Treatment Options Report provides a rank-ordered set of treatments for consideration, with supporting medical rationales and information regarding therapy access. The options themselves are chosen from a library of potential therapies, including those that go beyond standard of care and guidelines-based management, and even beyond clinical trial matching. The most promising treatments are identified and presented, even when non-traditional methods are needed to access those treatments (e.g., compassionate use program enrollment for an experimental treatment, or; patient assistance for access to a drug or drug combination outside of its primary indication).

Cancer Journeys and Treatment Options Reports are available to patients and their providers at no cost — patients participate with their data, and providers receive obligation-free information for any registered patient who has identified them as their treating oncologist. Both patients and linked providers receive access to xCures’ reports simultaneously, allowing for guided review and discussion.

A patient’s Treatment Options Report is generated through a combination of xCures’ technology, overseen by an expert team of Ph.D. scientists. It takes into account patient features, a broad set of patient outcomes data, expert recommendations, and insights from virtual tumor boards, public data sources, and an active learning network. Through xDECIDE, providers also have an opportunity to contribute to the refinement of xCures’ technology by making treatment decisions that feedback into xCures’ ever-growing knowledge base.

Providers who have collaborated with xCures via their xACCESS platform (e.g., expanded/managed access program) will see the xDECIDE toolset as an adjunct feature in their portal. As of today’s general availability of xDECIDE, all providers and staff users may also create new accounts via the following link: View Source To access these same resources as a patient, please register here: View Source