On May 13, 2021 Brickell Biotech, Inc. ("Brickell" or the "Company") (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Vical, MAY 13, 2021, View Source [SID1234579915]).
"The beginning of 2021 has been a very productive period for the Brickell team, as we continue to execute against our development strategy for sofpironium bromide gel, 15% as a potential best-in-class treatment option for primary axillary hyperhidrosis," commented Robert Brown, Chief Executive Officer of Brickell. "Most importantly, we continue to see patient enrollment in our Phase 3 pivotal clinical studies meet expectations, with enrollment completed last month in the Cardigan I study, and 70% enrollment surpassed in the Cardigan II study. As a result, we are on track to announce topline data from both studies in the fourth quarter of 2021. If these studies are successful, we expect to proceed towards an NDA submission to the U.S. FDA in 2022."

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Mr. Brown continued, "In April 2021, we were pleased to highlight data from the ARGYLE study, our Phase 3 open-label, long-term safety study of sofpironium bromide gel, as part of the late-breaking research program at the American Academy of Dermatology’s Virtual Meeting Experience 2021. In this study, sofpironium bromide gel was generally well-tolerated with continued efficacy during 48 weeks in patients with primary axillary hyperhidrosis. These data further contribute to our understanding of the long-term use of sofpironium bromide gel as a potential novel treatment for the millions of patients suffering from this chronic and debilitating condition."
Business and Recent Developments
•Completed enrollment in the Phase 3 Cardigan I study and exceeded 70% enrollment in the Phase 3 Cardigan II study. Both randomized, double-blinded, placebo-controlled pivotal studies are evaluating sofpironium bromide gel, 15% vs. placebo (1:1 ratio) in approximately 350 subjects (per study) aged nine and older with primary axillary hyperhidrosis.
•Presented results from the Phase 3 open-label, long-term safety study of sofpironium bromide gel, 5% and 15% in a late-breaking oral presentation at the American Academy of Dermatology’s Virtual Meeting Experience 2021 ("AAD VMX 2021"), in which the safety, tolerability, and efficacy results for sofpironium bromide gel, 5% and 15% were consistent with prior clinical experience and no unexpected safety findings were observed.
•Published validation results from the Company’s proprietary patient reported outcome scale, the Hyperhidrosis Disease Severity Measure-Axillary© (HDSM-Ax), in the peer-reviewed Journal of Drugs in Dermatology. The published results conclude that the HDSM-AX scale is a well-defined and reliable measure of primary axillary hyperhidrosis.
•Hosted a KOL event in March with leading dermatologists to discuss hyperhidrosis through both the eyes of a patient and diagnosing clinician, as well as the unmet need that exists in hyperhidrosis, the current treatment landscape, and the negative quality of life impacts experienced by both pediatric and adult patients.
•Japanese development partner, Kaken Pharmaceutical Co., Ltd. ("Kaken"), continued to ramp up commercialization efforts for sofpironium bromide gel, 5% (ECCLOCK) in Japan.
•Strengthened the Company’s balance sheet to $34.8 million in cash and cash equivalents at the end of the first quarter of 2021, which includes aggregate net proceeds of $10.6 million from warrant exercises and the sale of shares under a previously filed At-The-Market Equity Offering Program during the first quarter of 2021.

Upcoming Milestones
•On track to complete enrollment for the Cardigan II pivotal study in the third quarter of 2021.
•Expect to report topline results from the Cardigan I and II pivotal studies in the fourth quarter of 2021.
Financial Results
First Quarter 2021 Financial Results
The Company reported cash and cash equivalents of $34.8 million as of March 31, 2021, compared to $30.1 million as of December 31, 2020.
Revenue was approximately $17 thousand for the first quarter of 2021, compared to $1.0 million for the first quarter of 2020. Revenue in 2021 consisted of royalty revenue recognized related to sales of ECCLOCK in Japan by Kaken, while revenue in 2020 was driven by collaboration revenue recognized for research and development activities related to a license agreement with Kaken pursuant to which Kaken provided research and development funding to Brickell.
Research and development expenses were $6.1 million for the first quarter of 2021, compared to $2.7 million for the first quarter of 2020. This increase was primarily due to an increase in clinical costs related to the Phase 3 Cardigan studies, which were initiated in the fourth quarter of 2020.
General and administrative expenses were $3.0 million for the first quarter of 2021, compared to $2.5 million for the first quarter of 2020. The increase was primarily due to increases in compensation-related expense and professional fees.
Brickell’s net loss was $9.0 million for the first quarter of 2021 compared to $4.1 million for the first quarter of 2020.
Conference Call and Webcast Information
Brickell’s management will host a conference call today at 4:30 p.m. ET to discuss the financial results and recent corporate developments. The dial-in number for the conference call is 1-877-705-6003 for domestic participants and 1-201-493-6725 for international participants, with Conference ID #13718897. A live webcast of the conference call can be accessed through the "Investors" tab on the Brickell Biotech website at View Source A replay will be available on this website shortly after conclusion of the event for 90 days.
About Sofpironium Bromide
Sofpironium bromide is Brickell’s lead investigational product candidate and is a new chemical entity that belongs to a class of medications called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a range of bodily functions, including activation of the sweat glands. Sofpironium bromide was retrometabolically designed. Retrometabolic drugs are intended to exert their action locally and are potentially rapidly metabolized into a less active metabolite once absorbed into the blood. Sofpironium bromide gel, 15% is currently being evaluated in a U.S. pivotal Phase 3 clinical program for the treatment of primary axillary hyperhidrosis, and sofpironium bromide gel, 5% is approved in Japan for the same indication under the brand name ECCLOCK. Sofpironium bromide was discovered at Bodor Laboratories, Inc. by Dr. Nicholas Bodor D.Sc., d.h.c. (multi), HoF, Graduate Research Professor Emeritus, University of Florida.
About Hyperhidrosis
Hyperhidrosis is a debilitating, life-altering medical condition where a person sweats beyond what is physiologically required for thermoregulation of the body. More than 15 million people, or 4.8% of the population of the United States, and 12.76% of the population in Japan, are believed to suffer from hyperhidrosis1,2. Primary axillary (underarm) hyperhidrosis is the targeted first indication for sofpironium bromide and is the most common site of occurrence of hyperhidrosis, affecting an estimated 65% of patients with hyperhidrosis in the United States. Additional information can be found on the International Hyperhidrosis Society website: View Source

On May 13, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported financial results for the first quarter ended March 31, 2021 and provided a business update (Press release, Silverback Therapeutics, MAY 13, 2021, View Source [SID1234579931]).

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"In our first quarter as a public company, our team continues to execute on Silverback’s mission to bring tissue-targeted therapies to patients in need," said Laura Shawver, Ph.D., chief executive officer of Silverback. "We are on track to report interim clinical data for SBT6050 in the second half of this year, and we are equally excited about the progress and preclinical data emerging from SBT6290 and SBT8230, highlighting the broad applicability of our ImmunoTAC platform."

Recent Highlights

SBT6050 (HER2-TLR8 ImmunoTAC) continues to advance through monotherapy and pembrolizumab combination dose escalation arms of the Phase 1/1b clinical study. Silverback is on track to deliver interim clinical data from the monotherapy dose escalation arm of the study in the second half of 2021.
GLP toxicology studies have commenced for SBT6290 (Nectin4-TLR8 ImmunoTAC), with an IND submission anticipated in the fourth quarter of 2021. Dosing has been initiated in the GLP toxicology study and GMP manufacturing of the Phase 1 clinical supply is underway. In April 2021, Silverback presented data at the American Association of Cancer Research Annual Meeting 2021. These preclinical data showed that SBT6290 activates human myeloid cells in a Nectin4-dependent manner and that a SBT6290 mouse surrogate confers single agent anti-tumor activity in preclinical studies.
SBT8230 (ASGR1-TLR8 ImmunoTAC for chronic HBV) continues to advance through preclinical development with CMC activities underway. GLP toxicology studies are expected to commence in the first quarter of 2022.
Appointed Maria Koehler, M.D., Ph.D. to Board of Directors. In March 2021, Silverback appointed Dr. Koehler, M.D., Ph.D. to its board of directors, bringing more than 20 years of clinical development leadership experience.
First Quarter Financial Results

For the first quarter ended March 31, 2021, Silverback reported a net loss of $18.9 million, compared to a net loss of $5.3 million for the comparable period in 2020. Net loss for the first quarter of 2021 included non-cash stock-based compensation expense of $4.3 million compared to $47,000 for the same period in 2020.

Research and development expenses for the first quarter ended March 31, 2021 were $12.2 million, compared to $4.4 million for the same period in 2020. The increases in the Company’s research and development expenses in 2021 were primarily attributable to the advancement of pipeline programs, including SBT6290 and SBT8230, into preclinical development and the continued development of SBT6050. Silverback also incurred additional personnel-related expenses as operations grew in support of program advances.

General and administrative expenses for the first quarter ended March 31, 2021 were $6.6 million, compared to $0.8 million for the same period in 2020. The increases in general and administrative expenses were primarily attributable to an increase in personnel-related expenses due to increased headcount in 2020, including new executives, as well as increases in salaries, bonuses, and stock-based compensation. The increases in general and administrative expenses were also due to an increase in legal fees, professional fees, and other various general and administrative expenses as we now operate as a public company.

As of March 31, 2021, Silverback reported cash and cash equivalents of $374.2 million, compared to $386.6 million at December 31, 2020, which is expected to fund operating expenses and capital expenditure requirements for at least the next 24 months.

On May 13, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) ("Infinity" or the "Company"), a clinical-stage biotechnology company developing eganelisib (IPI-549), a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported its first quarter 2021 financial results and provided a corporate update (Press release, Infinity Pharmaceuticals, MAY 13, 2021, View Source [SID1234579916]).

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"2021 is poised to be a landmark year for Infinity with meaningful data updates, building on important data presentations over the last few months, which support the potential of eganelisib’s unique immune modulatory mechanism to improve outcomes across multiple solid tumor indications, lines of therapies and treatment combinations," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "Our encouraging results from MARIO-3 in front-line TNBC show a patient benefit from the addition of eganelisib to the approved standard of care regimen, Tecentriq and Abraxane. We are very much looking forward to sharing updated data from the study across a substantially larger number of patients, with an initial analysis of durability of response, in both mid-year and in the fourth quarter of this year. In order to provide the most meaningful update to our MARIO-3 TNBC presentation from SABCS in December 2020 for our mid-year TNBC update, our goal is to maximize the amount – both in terms of the number of patients and time on study – of data available by planning for a June data cut to be discussed on a July 27th webcast."

Ms. Perkins continued, "Our most recent data from MARIO-275 demonstrate the benefit of adding eganelisib to nivolumab in the advanced second line bladder cancer patient population irrespective of their PD-L1 status and especially for patients who are PD-L1 low who represent the majority of these patients and are least likely to respond to checkpoint inhibitors alone. Based on these results, we are in the planning stages of a potentially registration-enabling study, and we look forward to providing an update on our path forward in bladder cancer on our July 27th webcast based on our interactions with regulatory authorities and in the context of the recent FDA Oncologic Drugs Advisory Committee, or ODAC, meeting in which accelerated approvals for two checkpoint inhibitors in bladder cancer were reviewed."

Recent Updates and Program Guidance:

MARIO-3 Triple Negative Breast Cancer Cohort

Additional data from the triple negative breast cancer (TNBC) cohort of MARIO-3, the company’s ongoing Phase 2 study in collaboration with Roche/Genentech to evaluate eganelisib in a novel triple combination in the 1L setting, adding to Tecentriq and Abraxane, which has received accelerated approval in PD-L1 high 1L TNBC patients, are expected on July 27th and in 4Q 2021. Presentations will include increased patient numbers and early durability data, building upon the positive data presented at the 2020 San Antonio Breast Cancer Symposium which included 100% of patients who had some reduction and 69.2% of patients who had a response per RECIST 1.1, irrespective of PD-L1 status.
Completion of enrollment is expected in 2H’21
MARIO-275 and Advanced Urothelial Cancer

Presented positive data from the MARIO-275 randomized, placebo-controlled Phase 2 study evaluating eganelisib in combination with Opdivo in platinum-refractory, I/O naïve patients with advanced urothelial cancer (aUC), in collaboration with Bristol Myers Squibb (BMS) at the 2021 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU)
Combination of eganelisib with nivolumab demonstrated improved overall response rate (ORR), disease control rate (DCR), and progression free survival (PFS) versus 2L standard of care nivolumab monotherapy
Eganelisib increased the patient benefit over nivolumab monotherapy, regardless of PD-L1 status. The greatest benefit of eganelisib and nivolumab combination therapy over nivolumab monotherapy was observed in the PD-L1 low patient population (n=23) with improvement over nivolumab monotherapy (n=7): ORR of 26% vs. 14%; DCR 57% vs. 14%; and best responses of complete response (CR) 9% vs. 0%, and stable disease (SD) 30% vs. 0%
PD-L1 low patients demonstrated an extended progression free survival (PFS) with a hazard ratio of 0.54 representing a 46% reduction in probability of progression with the addition of eganelisib
The combination of eganelisib and nivolumab was well tolerated at the 30mg once daily dose
Translational data support eganelisib’s immune modulatory mechanism of action
Infinity is in the process of planning a potential registration enabling study leveraging findings from MARIO-275 and incorporating feedback from the U.S. Food and Drug Administration (FDA) including their ultimate decision following the recent ODAC reviews of checkpoint inhibitor accelerated approvals in PD-L1 high metastatic urothelial cancer patients and plans to provide an update on July 27th.
Corporate Update

Closed a $92 million public offering in February 2021 to support execution on the next phase of eganelisib development.
First Quarter 2021 Financial Results:

At March 31, 2021, Infinity had total cash, cash equivalents and available-for-sale securities of $106.8 million, compared to $34.1 million at December 31, 2020.
Research and development expense for the first quarter of 2021 was $8.2 million, compared to $7.3 million in the same period in 2020. The increase is primarily related to clinical, development and consulting expenses to support continued development of eganelisib.
General and administrative expense was $3.6 million for the first quarter of 2021, compared to $3.3 million for the same period in 2020. The increase in G&A expense is primarily due to an increase in stock compensation.
Net loss for the first quarter of 2021 was $11.6 million, or a basic and diluted loss per common share of $0.15, compared to a net loss of $10.9 million, or a basic and diluted loss per common share of $0.19 in the same period in 2020.
Financial Outlook: Infinity’s 2021 financial guidance, following the closing in February 2021 of a $92 million public offering of Infinity’s common stock is as follows:

Net Loss: Infinity expects net loss for 2021 to range from $40 million to $50 million.
Cash and Investments: Infinity expects to end 2021 with a year-end-cash, cash equivalents and available for sale securities balance ranging from $70 million to $80 million. Infinity’s financial guidance does not include additional funding or business development activities.
Conference Call Information

Infinity will host a conference call today, May 13th, 2021, at 4:30PM ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 9988449. An archived version of the webcast will be available on Infinity’s website for 30 days.

On May 13, 2021 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Terns Pharmaceuticals, MAY 13, 2021, View Source [SID1234579932]).

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"Our development team has continued to rapidly advance our NASH clinical programs, with top-line data for the Phase 2a LIFT study of FXR agonist TERN-101 in NASH now accelerated into June 2021. In the LIFT study, in addition to safety and tolerability, we are assessing multiple non-invasive endpoints, including MRI-PDFF (proton density fat fraction), a marker of steatosis, as well as ELF (enhanced liver fibrosis) and cT1 (MRI corrected T1) which are markers of fibrosis and/or inflammation linked to clinical outcomes and histological improvements in chronic liver diseases," said Senthil Sundaram, CEO at Terns. "In March, we initiated our first clinical trial of TERN-501 and look forward to announcing top-line data in the second half of 2021 that we hope will provide clinical confirmation of its high metabolic stability and differentiated pharmacokinetic profile."

Recent Developments and Anticipated 2021 Milestones
TERN-101: Liver-distributed farnesoid X receptor (FXR) agonist

Completed patient enrollment in the Phase 2a LIFT study in NASH patients in January 2021
Expecting top-line data from the Phase 2a LIFT study in June 2021
TERN-501: Thyroid hormone receptor-beta (THR-β) agonist

Initiated dosing in a first-in-human Phase 1 SAD/MAD clinical trial in March 2021
Expecting top-line data from the ongoing Phase 1 trial in 2H21
Composition of matter claims allowed by USPTO
TERN-201: Vascular adhesion protein-1 (VAP-1) inhibitor

Expecting to initiate dosing in 12-week Phase 1b clinical trial in NASH patients in 1H21 with expected top-line data in 1H22
GLP1-R: Oral, small-molecule receptor agonist

Expecting to nominate a final candidate in 2H21 for further development
Strengthened balance sheet

Completed an oversubscribed and upsized $147 million initial public offering in February 2021
Cash and equivalents support operations into 2024
Terns also announced today that Erin Quirk, M.D., will assume the position of Head of Research & Development, in addition to President and Chief Medical Officer, effective immediately. Weidong Zhong, Ph.D. will be leaving his position as Chief Scientific Officer and board member, effective as of July 2, 2021. In the interim, Dr. Zhong will continue to support Dr. Quirk to ensure a smooth transition.

Mr. Sundaram continued, "On behalf of our board and our entire team, I would like to thank Weidong for all of the contributions he made in founding Terns but also in successfully building and advancing our diverse NASH pipeline. At the same time, we are pleased to expand Erin’s title in recognition of her ongoing role in leading our research, development and manufacturing teams, which she has done since 2020. With Erin’s leadership, I am confident that we are well positioned to continue to advance our current and future pipeline candidates through all stages of research and development."

First Quarter Financial Results

Cash Position: As of March 31, 2021, cash, cash equivalents and marketable securities were $195.6 million as compared with $74.9 million as of December 31, 2020. Based on its current operating plan, Terns expects these will be sufficient to fund its planned operating expenses into 2024.
Research and Development (R&D) Expenses: R&D expenses were $8.7 million for the quarter ended March 31, 2021, as compared with $7.2 million for the quarter ended March 31, 2020.
General and Administrative (G&A) Expenses: G&A expenses were $4.6 million for the quarter ended March 31, 2021, as compared with $2.2 million for the quarter ended March 31, 2020.
Net Loss: Net loss was $13.3 million for the quarter ended March 31, 2021, as compared with $9.2 million for the quarter ended March 31, 2020.

On May 13, 2021 Alkermes plc (Nasdaq: ALKS) reported that the company will begin accepting applications for its Alkermes Inspiration Grants program beginning on May 20, 2021 (Press release, Alkermes, MAY 13, 2021, View Source [SID1234579948]). Now in its fifth year, this competitive grants program will provide up to a total of $500,000 in grants to assist nonprofit organizations in their work to address the needs of people living with addiction, serious mental illness or cancer. This program will prioritize funding for proposals that are designed to address the needs of historically under-resourced or underrepresented communities.

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"Our grant programs serve an important purpose in helping drive positive changes in the healthcare system. These programs complement our central mission of developing innovative medicines designed to address unmet patient needs," said Richard Pops, Chief Executive Officer of Alkermes. "The Alkermes Inspiration Grants program seeks to support people living with highly-stigmatized diseases, who often face unique challenges due to longstanding and widespread health disparities. In its fifth year, this program will continue to fund innovative programs that seek to support the physical, social and emotional needs of people living with addiction, serious mental illness and cancer."

Alkermes is seeking to support programs with a broad reach across the U.S. that have the potential to lead to sustained impact. Submissions will be evaluated based on the set of criteria outlined in the request for proposals, including a focus on people living with mental illness, substance use disorders and/or cancer; clearly defined needs, objectives, activity format, mode of delivery and intended audience; and relevance to historically under-resourced or underrepresented communities. Grant recipients will be selected by Alkermes. Eligible U.S. 501(c)(3) nonprofit organizations may submit a grant application by visiting View Source The 2021 application period will run from May 20, 2021 through June 17, 2021.

For more information on the Alkermes Inspiration Grants program, including the application, submission instructions and evaluation criteria, please visit View Source