On August 3, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the second quarter ended June 30, 2022 (Press release, Personalis, AUG 3, 2022, View Source [SID1234617388]).

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Second Quarter and Recent Highlights

Reported quarterly revenue of $18.2 million in the second quarter of 2022 compared with $21.7 million in the second quarter of 2021
Revenue from biopharma and other customers, excluding the VA MVP (as defined below), of $14.2 million in the second quarter of 2022 compared with $8.2 million in the second quarter of 2021, a 74% increase; revenue from biopharma and other customers includes revenue of $6.8 million from Natera in the second quarter of 2022; revenue from biopharma customers excluding Natera of $7.4 million for the second quarter of 2022
Revenue from the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP) of $4.0 million in the second quarter of 2022 compared with $13.5 million in the second quarter of 2021
Added another patent family to its molecular residual disease (MRD)-related IP portfolio, with priority to January 2013; the new patent describes the detection of MRD and recurrence by using whole genome sequencing of a patient’s tumor to identify variants for a personalized liquid biopsy assay
Appointed Lonnie Shoff to the Personalis Board of Directors effective August 2, 2022; Ms. Shoff brings extensive clinical diagnostics experience including executive roles at Thermo Fisher and Roche Diagnostics
Cash, cash equivalents, and short-term investments were $233.5 million as of June 30, 2022
"We are pleased with the pace of our oncology revenue growth compared with last year, as well as the continued adoption of our NeXT Platform, which is driven by the differentiation and strength of our offerings," said John West, Chief Executive Officer of Personalis. "We are making solid progress on our strategic priorities, with the goal of becoming the leading provider of the most comprehensive and actionable cancer genomic tests. Ultimately, we aim to enable a new standard of oncology care to help patients live better and longer lives."

Second Quarter 2022 Financial Results

Revenue was $18.2 million in the three months ended June 30, 2022
Gross margin was 23.5% in the three months ended June 30, 2022
Operating expenses were $32.2 million in the three months ended June 30, 2022
Net loss was $27.5 million in the three months ended June 30, 2022 and net loss per share was $0.60 based on a weighted-average basic and diluted share count of 45.6 million
Cash, cash equivalents, and short-term investments were $233.5 million as of June 30, 2022
Full Year 2022 Outlook

Personalis expects the following for the full year of 2022:

Total company revenue is expected to be in the range of $62.0 million to $67.0 million
Revenue from biopharma and all other customers, excluding the VA MVP, is expected to be in the range of $55.0 million to $60.0 million
Net loss is expected to be in the range of $110.0 million to $115.0 million
Webcast and Conference Call Information

Personalis will host a conference call to discuss the second quarter 2022 financial results after market close on Wednesday, August 3, 2022 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. To access the live call via telephone, please register in advance using the link here. Upon registering, each participant will receive an email confirmation with dial-in numbers and a unique personal PIN that can be used to join the call. The live webinar can be accessed at View Source A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On August 3, 2022 Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, reported financial results for the second quarter ended June 30, 2022, a mid-year corporate update, and interim clinical results of an open-label study with simufilam (Press release, Pain Therapeutics, AUG 3, 2022, View Source [SID1234617387]). Simufilam is Cassava Sciences’ lead drug candidate for the proposed treatment of Alzheimer’s disease. SavaDx is Cassava Sciences’ investigational diagnostic candidate to detect Alzheimer’s disease from a simple blood draw.

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"I’m pleased with our operating performance in the first half of 2022," said Remi Barbier, President & CEO. "I’m also humbled by the hard work of our team members and clinical partners. Persistence and a focus on performance are key when you’re trying to beat Alzheimer’s disease."

Update on Patient Enrollment for Phase 3 Program
A total of over 400 patients are now enrolled in our on-going Phase 3 program of simufilam in Alzheimer’s disease. Enrollment is almost evenly split between the two Phase 3 studies.

Overview of Phase 3 Program with Simufilam in Alzheimer’s Disease
Our Phase 3 program consists of two double-blind, randomized, placebo-controlled studies of simufilam in patients with mild-to-moderate Alzheimer’s disease. Both Phase 3 studies have Special Protocol Assessments (SPA) from the U.S. Food and Drug Administration. Both studies have the same co-primary efficacy endpoints: ADAS-Cog12 (a cognitive scale) and ADCS-ADL (a functional scale). A secondary efficacy endpoint for both studies is iADRS, a clinical tool that combines cognitive and functional scores from ADAS-Cog & ADCS-ADL. Patients are now being screened in clinical trial sites in the U.S., Canada, Puerto Rico and Australia.

RETHINK-ALZ is the trade name of our 52-week Phase 3 study. This randomized, double-blind, placebo-controlled study is designed to evaluate the safety & efficacy of oral simufilam 100 mg or placebo, twice daily, over 52 weeks in approximately 750 patients with Alzheimer’s disease.

REFOCUS-ALZ is the trade name of our 76-week Phase 3 study. This randomized, double-blind, placebo-controlled study is designed to evaluate the safety & efficacy of oral simufilam 100 mg, 50 mg or placebo, twice daily, over 76 weeks in approximately 1,000 patients with Alzheimer’s.

Future Open-label Extension Study for the Phase 3 Program
In the second half of 2022, we expect to initiate an open-label extension study for our Phase 3 program. This new study is designed to provide no-cost access to simufilam to patients with Alzheimer’s disease who have successfully completed a Phase 3 study of simufilam.

On-going Open-label Study with Simufilam in Alzheimer’s Disease
In March 2020, we initiated a long-term, open-label study to evaluate simufilam in patients with mild-to-moderate Alzheimer’s disease. The study is intended to monitor the long-term safety and tolerability of simufilam 100 mg twice daily over 12 months or more. This study has reached its target enrollment of approximately 200 patients. We expect all patients for this study will complete drug treatment in Q4 2022. We expect to announce top-line clinical results for this study approximately year-end 2022.

On-going Open-label Study – Interim Analysis on 100 Subjects at 12 Months
An interim analysis was conducted on the first 100 evaluable patients who completed at least 12 months of open-label treatment with simufilam 100 mg twice daily. Top-line results of this interim analysis show that from baseline to month-12:

Drug appears safe and well tolerated.
Overall ADAS-Cog11 scores improved an average of 1.5 points (S.D. ± 6.6; P<0.05)
63% of the 100 patients showed an improvement in ADAS-Cog11 scores, and this group of patients improved an average of 5.6 points (S.D. ± 3.8).
An additional 21% of the 100 patients declined less than 5 points on ADAS-Cog11, and this group of patients declined an average of 2.7 points (S.D. ± 1.4).
The 11-item Alzheimer’s Disease Assessment Scale–Cognitive subscale (ADAS-Cog) was originally developed by the research community to measure cognitive impairment in patients with Alzheimer’s disease. ADAS-Cog is often used in clinical studies of patients with Alzheimer’s because it can help determine incremental improvements or declines in cognition over time.

Standard deviation ("S.D.") is a measure of how dispersed the data is in relation to the average. A low standard deviation generally shows the data are closely clustered around the average. A high standard deviation generally shows that the data is widely spread.

All clinical data from our open-label study are inherently exploratory in nature and, as with all open-label data, should be interpreted with caution. Data results from our open-label study does not constitute, and should not be interpreted as, evidence of therapeutic benefit for simufilam.

Cognition Maintenance Study (CMS) with Simufilam in Alzheimer’s Disease
In May 2021, we initiated a Cognition Maintenance Study (CMS). This is a double-blind, randomized, placebo-controlled study of simufilam in patients with mild-to-moderate Alzheimer’s disease. Study participants are randomized (1:1) to simufilam or placebo for six months. The CMS is designed to evaluate simufilam’s effects on cognition and health outcomes in Alzheimer’s patients who continue with drug treatment versus patients who discontinue drug treatment. To enroll in the CMS, patients must have previously completed 12 months or more of open-label treatment with simufilam.

The target enrollment for the CMS is 100 or more patients. Over 50 patients have now completed this study. Our goal is to complete patient enrollment for the CMS in Q4 2022. We expect to announce clinical results of the CMS approximately third-quarter 2023.

SavaDx
Our investigational product candidate, called SavaDx, is an early-stage program focused on detecting the presence of Alzheimer’s disease from a simple blood draw. SavaDx is currently designed as an antibody-based detection system for altered filamin A (FLNA) protein. Working with third parties, we continue to evaluate an innovative method to detect FLNA without the use of antibodies. For business, technical and personnel reasons, we continue to prioritize the development of simufilam, our novel drug candidate, over SavaDx.

Financial Update
Net loss for the second quarter 2022 was $19.3 million, or $0.48 per share, compared to a net loss of $5.1 million, or $0.13 per share, for the same period in 2021. Net cash used in operations was $34.6 million during the first six months of 2022. Net cash use for operations for full-year 2022 is expected to be approximately $80 to $90 million. Cash and cash equivalents were $197.2 million as of June 30, 2022, with no debt.

Financial Results for Second Quarter 2022

At June 30, 2022, cash and cash equivalents were $197.2 million, with no debt.
Net loss was $19.3 million, or $0.48 per share. This compares to a net loss of $5.1 million, or $0.13 per share, for the same period in 2021. Net loss increased compared to the prior period due primarily to a significant increase in our R&D activities for a Phase 3 program of simufilam in Alzheimer’s disease.
Net cash used in operations was $34.6 million during the first six months of 2022.
Net cash use in operations for full year 2022 is expected to be approximately $80 to $90 million.
Research and development (R&D) expenses were $16.9 million. This compared to $3.9 million for the same period in 2021. R&D expenses increased compared to the prior period due primarily to increased activities and expenses related to clinical and pre-clinical studies and support functions and personnel expenses.
General and administrative (G&A) expenses were $3.0 million. This compared to $1.2 million for the same period in 2021. G&A expenses increased compared to the prior period due primarily to increased activities and expenses related to legal services as well as depreciation and amortization.
About Simufilam
Simufilam (sim-uh-FILL-am) is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA) protein in the brain. Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimer’s disease, and related technologies, without royalty obligations to any third party.

On August 3, 2022 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported financial results for the second quarter of 2022 (Press release, Pacira Pharmaceuticals, AUG 3, 2022, View Source;991.htm [SID1234617386]).

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Second Quarter 2022 Financial Highlights

Total revenues of $169.4 million
Net product sales of $137.0 million for EXPAREL, $27.4 million for ZILRETTA, and $3.2 million for iovera°
Net income of $19.9 million, or $0.44 per share (basic) and $0.40 per share (diluted)
Adjusted EBITDA of $44.9 million
"We achieved record revenue for the second quarter, which was marked by strength across the entire portfolio amid ongoing market headwinds. We continue to invest in our training facilities and marketing programs to help facilitate growth throughout the balance of the year and beyond," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "The second quarter also marked our 21st consecutive quarter of positive adjusted EBITDA, which underscores our consistency and reliability as stewards for our stakeholders. We continue to execute our strategy, confident that the ongoing transition of surgeries to the outpatient setting and other market dynamics will support our growth as we work to create lasting value."

Recent Business Highlights

Completion of Patient Enrollment in Two Phase 3 Registration Studies of EXPAREL as a Lower Extremity Nerve Block. Today the company is announcing the completion of patient enrollment in its two Phase 3 studies of EXPAREL as a nerve block in lower extremity surgeries. The first study is evaluating EXPAREL as an adductor canal block for total knee arthroplasty and the second is evaluating EXPAREL as a popliteal sciatic nerve block for bunionectomy. The company believes positive results from these studies will form the basis for a Supplemental New Drug Application submission seeking label expansion to include lower extremity nerve blocks.
New EXPAREL Patent and Notice of Allowance. In June 2022, the U.S. Patent and Trademark Office (USPTO) issued Patent Number 11,357,727. This patent is a product by process patent, with an expiration date of January 22, 2041. This patent is now listed in the U.S. Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalents Evaluations (Orange Book). In July, the company received a Notice of Allowance from the USPTO for a U.S. Patent Application claiming chemical composition of EXPAREL. After issuance, Pacira will submit this patent for listing in the Orange Book.
Second Quarter 2022 Financial Results

Total revenues were $169.4 million in the second quarter of 2022, versus the $135.6 million reported for the second quarter of 2021.
EXPAREL net product sales were $137.0 million in the second quarter of 2022, versus the $130.1 million reported for the second quarter of 2021.
ZILRETTA net product sales were $27.4 million in the second quarter of 2022. The company began recognizing ZILRETTA sales upon completing its acquisition of Flexion Therapeutics, Inc. in November 2021.
Second quarter 2022 iovera° net product sales were $3.2 million, versus the $3.8 million reported for the second quarter of 2021.
Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $1.0 million in the second quarter of 2022, versus the $1.0 million reported for the second quarter of 2021.
Second quarter 2022 royalty and collaborative licensing and milestone revenues were $0.8 million, versus the $0.7 million reported for the second quarter of 2021.
Total operating expenses were $138.2 million in the second quarter of 2022, versus the $100.7 million reported for the second quarter of 2021.
Research and development (R&D) expenses were $26.3 million in the second quarter of 2022, compared to $12.6 million in the second quarter of 2021. R&D expenses included $5.1 million and $4.6 million of product development and manufacturing capacity expansion costs in the second quarters of 2022 and 2021, respectively.
Selling, general and administrative (SG&A) expenses were $65.0 million in the second quarter of 2022, compared to $50.8 million in the second quarter of 2021.
GAAP net income was $19.9 million, or $0.44 per share (basic) and $0.40 per share (diluted), in the second quarter of 2022, compared to $19.1 million, or $0.43 per share (basic) and $0.42 per share (diluted), in the second quarter of 2021.
Non-GAAP net income was $24.0 million, or $0.53 per share (basic) and $0.51 per share (diluted), in the second quarter of 2022, compared to $35.3 million, or $0.80 per share (basic) and $0.77 per share (diluted), in the second quarter of 2021.
Adjusted EBITDA was $44.9 million in the second quarter of 2022, compared to $50.3 million in the second quarter of 2021.
Pacira ended the second quarter of 2022 with cash, cash equivalents and short-term available-for-sale investments ("cash") of $316.4 million. Cash provided by operations was $29.8 million in the second quarter of 2022, compared to $30.1 million in the second quarter of 2021.
Pacira had 45.5 million basic and 52.5 million diluted weighted average shares of common stock outstanding in the second quarter of 2022.
See "Non-GAAP Financial Information" below.

Financial Guidance

Since early 2020, the company’s revenues have been impacted by COVID-19 and pandemic-related challenges that included the significant postponement or suspension in the scheduling of elective surgical procedures due to public health guidance and government directives. While the degree of impact has diminished during the course of the pandemic due to the introduction of vaccines and the lessening of elective surgery restrictions, certain pandemic-related operational challenges persist. It remains unclear how long it will take the elective surgery market to normalize or if restrictions on elective procedures will recur due to future COVID-19 variants or otherwise. Given the continued uncertainty around labor shortages, COVID-19 and the pace of recovery for the elective surgery market, the company is currently not providing revenue or gross margin guidance. To provide greater transparency, Pacira is reporting monthly intra-quarter unaudited net product sales for EXPAREL, ZILRETTA, and iovera° until it has gained enough visibility around the impacts of COVID-19. Pacira is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com

Today the company is reiterating its full-year 2022 operating expense guidance as follows:

Non-GAAP R&D expense of $75 million to $85 million; and
Non-GAAP SG&A expense of $220 million to $230 million.
The company is adjusting its full-year 2022 guidance for stock-based compensation to $47 million to $50 million.

See "Non-GAAP Financial Information" below.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Wednesday, August 3, 2022, at 8:30 a.m. ET. To participate in the conference call, dial 1-800-715-9871 and provide the passcode 9287305. International callers may dial 1-646-307-1963 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-800-770-2030 (domestic) or 1-609-800-9909 (international) using the passcode 9287305. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income, non-GAAP net income per common share, non-GAAP weighted average common shares outstanding-diluted, non-GAAP cost of goods sold, non-GAAP research and development (R&D) expense, non-GAAP selling, general and administrative (SG&A) expense, and adjusted EBITDA (as defined below), because these non-GAAP financial measures exclude the impact of items that management believes affect comparability or underlying business trends.

These measures supplement the company’s financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, R&D expense and SG&A expense outlook for 2022 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of the Company’s financial statements by providing greater transparency into the operating performance of Pacira and its future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures.

On August 3, 2022 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that James Porter, Ph.D., Chief Executive Officer, will present at the Canaccord Genuity 42nd Annual Growth Conference on Wednesday, August 10, 2022, at 4:00 p.m. ET in Boston (Press release, Nuvalent, AUG 3, 2022, View Source [SID1234617385]).

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A live webcast will be available in the Investors section of the company’s website at www.nuvalent.com, and archived for 30 days following the presentation.

On August 3, 2022 Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, reported corporate highlights and financial results for the second quarter of 2022 (Press release, Morphic Therapeutic, AUG 3, 2022, View Source [SID1234617384]).

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Second Quarter 2022 and Recent Corporate Highlights

Continued enrollment of EMERALD-1 (MORF-057-201) phase 2a study
EMERALD-1, an open-label multi-center study of MORF-057 enrolling up to 35 patients with moderate to severe ulcerative colitis (UC), who will receive 100 mg BID (twice daily), continues to progress as planned
EMERALD-2 (MORF-057-202), a global phase 2b double-blind randomized placebo-controlled trial of MORF-057, is now expected to begin in the fourth quarter of 2022 and top line results are expected in the first half of 2025
Announced several key leadership appointments and promotions
Appointed Joanne Gibbons as Senior Vice President of Regulatory Affairs
Ms. Gibbons has nearly 25 years of experience in Regulatory Affairs and Clinical Development, both in the development of novel drugs and the expansion of marketed products
Named Dr. Bruce Rogers as President of Morphic Therapeutic
Dr. Rogers previously served as Morphic’s Chief Scientific Officer from 2016
Dr. Rogers has over 25 years of biopharmaceutical experience, including 18 years of experience in roles of increasing responsibility at Pfizer
Named Dr. Blaise Lippa as Chief Scientific Officer of Morphic
Dr. Lippa previously served as Morphic’s Senior Vice President of Molecular Discovery and was part of the founding team at Morphic
Dr. Lippa has over 20 years of experience in the biopharmaceutical industry, including time at Pfizer and Cubist, prior to its acquisition by Merck
Advanced the Company’s research and development collaboration with Janssen, focused on an antibody activator of a high potential integrin target
Concluded the Company’s research and development collaboration efforts with AbbVie
Morphic successfully delivered on the terms of the AVB6 collaboration and Morphic and AbbVie are in the process of drafting a joint publication for the AVB6 program
"Morphic is confidently climbing through a vital period in our development as the EMERALD clinical trials of MORF-057 in UC move forward flat out," commented Praveen Tipirneni, MD, Chief Executive Officer of Morphic Therapeutic. "The EMERALD-1 phase 2a study is progressing according to plan and our esprit de corps continues to strengthen through several senior appointments. Most notably, we announced the promotion of two key longstanding and high performing executives, Bruce Rogers and Blaise Lippa, and the addition of our new SVP of Regulatory Affairs, Joanne Gibbons. With the additional capital raised in the second quarter and refined operating plans, we have bolstered our financial position and extended our cash-runway into 2025, well after the primary endpoint readout of the EMERALD-2 phase 2b study."

Financial Results for the Second Quarter 2022

Net income for the quarter ended June 30, 2022 was $26.8 million or $0.68 per share compared to a net loss of $27.8 million or $0.77 per share for the same quarter last year
Revenue was $60.2 million for the quarter ended June 30, 2022, compared to $3.8 million for the same quarter last year. The increase was primarily due to the forthcoming conclusion of the collaboration with AbbVie which resulted in $57.7 million recognition of collaboration revenue in the quarter ended June 30, 2022
Research and development expenses were $25.7 million for the quarter ended June 30, 2022, as compared to $24.6 million for the same quarter last year. The increase was primarily attributable to higher clinical and development costs along with higher pre-clinical and phase 2 clinical trial costs to support our lead product candidate MORF-057
General and administrative expenses were $8.2 million for the quarter ended June 30, 2022, compared to $7.1 million for the same quarter last year. The increase was due to increased non-cash stock-based compensation expense and higher payroll costs
As of June 30, 2022, Morphic had cash, cash equivalents and marketable securities of $397.6 million, compared to $380.7 million as of March 31, 2022. We have updated our current operating plan with the receipt of $39.2 million in net proceeds raised under our ATM; the focusing and reduction in the scope of our partnered programs; a proactive pipeline prioritization and the implementation of increased operational efficiencies. Morphic believes its cash, cash equivalents and marketable securities as of June 30, 2022, will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2025.