On November 2, 2021 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we") reported its third-quarter 2021 financial results (Press release, Bausch Health, NOV 2, 2021, View Source [SID1234594071]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our third-quarter 2021 results continue to demonstrate that our recovery from the effects of the COVID-19 pandemic remains in progress across our business segments," said Joseph C. Papa, chairman and CEO, Bausch Health. "In the third quarter, several key products grew and gained market share. Additionally, we are delivering on multiple near-term R&D catalysts that we believe will help drive future growth."

"We have remained steadfast in our commitment and have been working diligently to accelerate the strategic alternatives process that will enable us to unlock value in our three attractive businesses as soon as possible," continued Mr. Papa. "We are excited to announce that, subject to market conditions and other approvals, we expect to launch the proposed IPO of our Solta Medical business in December 2021 or January 2022, and following that, we expect to launch the Bausch + Lomb IPO approximately 30 days later, also subject to market conditions and other approvals."3

Select Company Highlights

Launched Biotrue Hydration Boost Lubricant Eye Drops in the United States
Completed divestiture of Amoun Pharmaceutical Company S.A.E. (Amoun) to Abu-Dhabi-based ADQ
Repaid debt by $1.100 billion in the third quarter of 2021 using cash on hand, cash generated from operations and in connection with the Amoun divestiture
Pipeline Advancements

Received U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA) for XIPERE4 (triamcinolone acetonide injectable suspension), a therapy that uses the suprachoroidal space to treat patients suffering from macular edema associated with uveitis; launch is expected to occur in the first quarter of 2022
Announced statistically significant topline results from the second Phase 3 trial evaluating the investigational drug NOV035 (perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease associated with Meibomian gland dysfunction; Bausch Health expects to file an NDA with the FDA in the first half of 2022
VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, received regulatory approval in Thailand
Accelerating Strategic Alternatives
The Company has continued to execute upon its plans to pursue an initial public offering (IPO) of its Solta Medical (Solta) business. In preparation for the IPO, the Company has submitted a confidential S-1 to the U.S. Securities and Exchange Commission and has made key leadership appointments. The Company expects to launch the Solta IPO in December 2021 or January 2022, subject to market conditions and regulatory, stock exchange and other approvals. In addition, the Company has continued to execute upon its previously announced plans to separate Bausch + Lomb from Bausch Pharma6 and expects to launch an IPO for Bausch + Lomb approximately 30 days after the IPO of Solta, subject to market conditions and regulatory, stock exchange and other approvals. After that, the Bausch + Lomb spinoff can occur following the expiry of customary lock-ups and receipt of applicable shareholder and other necessary approvals and the achievement of the Company’s target net leverage ratios.2

Third-Quarter 2021 Revenue Performance
Total reported revenues were $2.111 billion for the third quarter of 2021, as compared to $2.138 billion in the third quarter of 2020, a decrease of $27 million. Excluding the favorable impact of foreign exchange of $19 million and the impact of divestitures and discontinuations of $46 million, primarily due to the divestiture of Amoun, revenue was flat organically1,7, compared to the third quarter of 2020.

On November 2, 2021 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the third quarter of 2021 and provided a corporate update (Press release, Aclaris Therapeutics, NOV 2, 2021, View Source [SID1234594070]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This quarter we are pleased to announce the submission of an investigational new drug application for ATI-2138, our investigational oral ITK/TXK/JAK3 inhibitor, the third novel clinical candidate generated by our proprietary KINect drug discovery platform," said Dr. Neal Walker, President & CEO of Aclaris. "If allowed, we plan to progress ATI-2138 into a Phase 1 trial. We also continue to make progress toward initiating a Phase 2b trial of zunsemetinib (ATI-450) in moderate to severe rheumatoid arthritis and Phase 2 trials of zunsemetinib in psoriatic arthritis and moderate to severe hidradenitis suppurativa, as well as our Phase 2b trial of ATI-1777 in moderate to severe atopic dermatitis."

Research and Development Highlights:

The global COVID-19 pandemic continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its research and development and regulatory activities listed below.

Clinical Programs
MK2 Inhibitor Asset
Zunsemetinib (ATI-450), an investigational oral small molecule MK2 inhibitor compound:
Zunsemetinib has been adopted as the nonproprietary name for ATI-450.
Aclaris plans to progress zunsemetinib into a Phase 2b trial in moderate to severe rheumatoid arthritis in the fourth quarter of 2021.
Aclaris also plans to progress zunsemetinib into Phase 2 trials in psoriatic arthritis and moderate to severe hidradenitis suppurativa.
In pre-clinical studies, positive effects on MK2 inhibition have been observed for breast cancer metastasis and cancer-associated bone loss.
"Soft" JAK Inhibitor Asset
ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor compound:
Aclaris plans to progress ATI-1777 into a Phase 2b trial in moderate to severe atopic dermatitis in the first half of 2022. In this trial, Aclaris plans to explore multiple concentrations of twice daily treatment with ATI-1777 and a single concentration of once daily treatment with ATI-1777.
Preclinical Programs
ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:
Currently being developed as a potential treatment for T-cell mediated diseases such as psoriasis and/or inflammatory bowel disease.
Aclaris submitted an Investigational New Drug Application (IND) for ATI-2138 for the treatment of psoriasis in October 2021 and, if allowed, Aclaris plans to progress to a first-in-human Phase 1 single ascending dose trial of ATI-2138 in healthy volunteers.
ATI-2231, an investigational oral MK2 inhibitor compound:
Second MK2 inhibitor generated from Aclaris’ proprietary KINect drug discovery platform and designed to have a long half-life.
Currently being explored as a potential treatment for pancreatic cancer and metastatic breast cancer as well as in preventing bone loss in patients with metastatic breast cancer.
IND-enabling studies are underway.
Discovery Programs
Currently developing oral gut-restricted JAK inhibitors with limited systemic exposure as potential treatments for inflammatory bowel disease.
Central nervous system (CNS) kinase inhibitor targets
Currently engaged in research to identify brain penetrant kinase inhibitor candidates and assess their impact on neuronal pro-inflammatory cytokine production, microglia growth and survival, and neurodegeneration.
Planned Retirement
Kamil Ali-Jackson, Co-Founder, Chief Legal Officer, Chief Compliance Officer and Corporate Secretary has announced her retirement, effective January 3, 2022. "Kamil was one of the co-founders of Aclaris in 2012 and on behalf of the entire Aclaris team and our Board of Directors, I thank Kamil for her hard work and dedication to the company," said Dr. Walker. "During her tenure, Kamil has been responsible for building and overseeing Aclaris’ Legal, Compliance, Corporate Communications, Human Resources, and Quality functions and her significant contributions have contributed to the success of the company. We wish Kamil the very best in her retirement."
Financial Highlights:

Liquidity and Capital Resources

As of September 30, 2021, Aclaris had aggregate cash, cash equivalents and marketable securities of $243.6 million compared to $54.1 million as of December 31, 2020. The primary factors for the change in cash, cash equivalents and marketable securities during the nine months ended September 30, 2021 included:

Net cash used in operating activities of $35.1 million. This amount was comprised of the following:
$68.1 million net loss
$0.8 million cash used from changes in operating assets and liabilities
$22.1 million of non-cash charges for the revaluation of contingent consideration
$10.2 million of non-cash stock-based compensation expense
$1.5 million of other non-cash charges
Net cash used to repay outstanding debt and fees of $11.5 million in July 2021.
Net proceeds of $238.2 million from public offerings in January and June 2021 in which Aclaris sold a total of 14.4 million shares of common stock.
Aclaris anticipates that its cash, cash equivalents and marketable securities as of September 30, 2021 will be sufficient to fund its operations through the end of 2024, without giving effect to any potential business development transactions or financing activities.

Financial Results

Third Quarter 2021

Net loss was $21.1 million for the third quarter of 2021 compared to $10.7 million for the third quarter of 2020.
Total revenue was $1.7 million for the third quarter of 2021 compared to $1.4 million for the third quarter of 2020.
Research and development (R&D) expenses were $14.0 million for the quarter ended September 30, 2021 compared to $6.2 million for the prior year period.
The $7.7 million increase was primarily the result of additional zunsemetinib expenses, including costs associated with drug product manufacturing and clinical development activities for a Phase 2b trial for moderate to severe rheumatoid arthritis and a Phase 2 trial for moderate to severe hidradenitis suppurativa.
General and administrative (G&A) expenses were $6.0 million for the quarter ended September 30, 2021 compared to $3.9 million for the prior year period.
The $2.1 million increase was primarily the result of higher compensation-related costs, including stock-based compensation as well as higher accounting, compliance and professional fees.
Revaluation of contingent consideration charges related to the Confluence acquisition was $0.9 million for the quarter ended September 30, 2021 compared to $0.6 million for the prior year period.
Year-to-date 2021

Net loss was $68.1 million for the nine months ended September 30, 2021 compared to $37.8 million for the nine months ended September 30, 2020.
Total revenue was $5.3 million for the nine months ended September 30, 2021 compared to $4.9 million for the nine months ended September 30, 2020.
R&D expenses were $29.7 million for the nine months ended September 30, 2021 compared to $20.4 million for the prior year period.
The $9.3 million increase was primarily the result of additional zunsemetinib expenses, including costs associated with drug product manufacturing and clinical development activities for a Phase 2b trial for moderate to severe rheumatoid arthritis and a Phase 2 trial for moderate to severe hidradenitis suppurativa. Continued investment in the further development of Aclaris’ immuno-inflammatory drug development pipeline also contributed to the increase as Aclaris progressed towards an IND submission for ATI-2138.
G&A expenses were $16.7 million for the nine months ended September 30, 2021 compared to $15.6 million for the prior year period.
The $1.0 million increase was primarily the result of higher accounting, compliance and professional fees.
Revaluation of contingent consideration charges related to the Confluence acquisition was $22.1 million for the nine months ended September 30, 2021 compared to $2.4 million for the prior year period.

On November 2, 2021 Leidos Holdings, Inc. (NYSE: LDOS), a FORTUNE 500 science and technology leader, reported financial results for the third quarter of fiscal year 2021 (Press release, Leidos, NOV 2, 2021, View Source [SID1234594069]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Roger Krone, Leidos Chairman and Chief Executive Officer, commented, "The third quarter marked another strong quarter for Leidos, with record levels of revenues, adjusted EBITDA, non-GAAP diluted EPS, and backlog. Our success is the direct result of building a business portfolio focused on vital missions and a workforce that is motivated to enhance those missions through technology, engineering, and science. As we described at our October Investor Day, we see continued success ahead based on our scale, positioning, and talented people."

Revenues for the quarter were $3.48 billion, up 7% compared to the prior year quarter. Excluding acquired revenues of $47 million, revenues increased 6% organically. Revenues grew across all reportable segments; the largest contributors were the increase in veterans’ disability examinations after the pause from the COVID-19 pandemic and the start-up of the Navy Next Generation IT contract.

Net income was $208 million, or $1.43 per diluted share. Net income was up 28% and diluted EPS was up 27% from the third quarter of fiscal year 2020. The weighted average diluted share count for the quarter was 143 million compared to 144 million in the prior year quarter. Net income margin increased from 5.0% to 6.0% year-over-year as a result of the strong program management and higher volumes on certain fixed price programs.

Adjusted EBITDA was $403 million for the third quarter, up 16% year-over-year; adjusted EBITDA margin increased from 10.7% to 11.6% over the same period consistent with the increase in operating income margin. Non-GAAP net income was $260 million for the third quarter, which was up 23% year-over-year, and non-GAAP diluted EPS for the quarter was $1.80, which was up 22% compared to the third quarter of fiscal year 2020.

Cash Flow Summary

In the third quarter of fiscal year 2021, Leidos generated $565 million of net cash provided by operating activities for an operating cash flow conversion ratio of 276%. After adjusting for payments for property, equipment and software, quarterly free cash flow was $541 million for a free cash flow conversion ratio of 211%. In addition, Leidos used $53 million in investing activities and used $209 million in financing activities.

During the third quarter of fiscal year 2021, Leidos made open market repurchases of common stock for an aggregate purchase price of $137 million and returned $51 million to shareholders as part of its regular quarterly cash dividend program. In addition, Leidos paid down $27 million of debt and completed a small, strategic acquisition for preliminary purchase consideration of approximately $36 million. As of October 1, 2021, Leidos had $587 million in cash and cash equivalents and $5.1 billion of debt.

On October 29, 2021, the Leidos Board of Directors declared that Leidos will pay a cash dividend of $0.36 per share on December 30, 2021 to stockholders of record at the close of business on December 15, 2021.

New Business Awards

Net bookings totaled $4.7 billion in the quarter, representing a book-to-bill ratio of 1.4. As a result, backlog at the end of the quarter was $34.7 billion, of which $7.3 billion was funded. Included in the quarterly bookings were several particularly important awards:

High-Resolution Three Dimensional (3D) Geospatial Information Operation and Technology Integration Program. Leidos was awarded a prime contract by the U.S. Army to support the Army Geospatial Center’s (AGC) Buckeye program. Under the contract, Leidos will continue to support AGC’s BuckEye mission. The BuckEye program provides mission critical unclassified high resolution color imagery and digital 3D terrain over all operationally relevant areas of the world. The single-award contract has a one-year base period of performance followed by three one-year options and a total estimated value of $600 million if all options are exercised.
Technical Signals Intelligence. Leidos was awarded a prime contract by the National Security Agency (NSA) to provide development and modernization efforts in support of the agency’s Technical Signals Intelligence (TechSIGINT) mission. Under the contract, Leidos will provide the technical services to develop, deploy and sustain a wide range of new and improved TechSIGINT collection, production and analysis capabilities. The single award contract has a five-year base period of performance and holds a ceiling value of $300 million.
Enduring Indirect Fires Protection Capability. Leidos was awarded a contract by the U.S. Army Program Executive Office Missiles and Space for the Enduring Indirect Fires Protection Capability (IFPC) to provide its mobile ground-based weapon system. Under the contract, Dynetics, a wholly owned subsidiary of Leidos, will produce a transportable system designed to engage and defeat Cruise Missile (CM) and Unmanned Aircraft System (UAS) threats. The award has an estimated value of $237 million over the next 2.5 years.
In addition, Leidos received prime positions on several indefinite delivery/indefinite quantity (IDIQ) contracts that provide competitive differentiation and channels for future growth but are not included in bookings or backlog beyond any awarded task orders. The largest of these IDIQs was:

Low-Energy Portal. Leidos was awarded a new prime contract by U.S. Customs and Border Protection (CBP) to provide Low-Energy Portal (LEP) systems for non-intrusive inspection (NII) of passenger vehicles at U.S.-Mexico land border crossings. Under the contract, Leidos will integrate, deploy and train CBP staff to use its VACIS LEP systems, incorporating Viken Detection’s OSPREY scanning technology. The multiple-award LEP contract has a total ceiling value of $390 million.
Forward Guidance

For information regarding adjusted EBITDA margin and non-GAAP diluted EPS, see the related explanations and reconciliations to GAAP measures included elsewhere in this release.

Leidos does not provide a reconciliation of forward-looking adjusted EBITDA margins or non-GAAP diluted EPS to net income attributable to Leidos shareholders, due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. Because certain deductions for non-GAAP exclusions used to calculate projected net income attributable to Leidos shareholders may vary significantly based on actual events, Leidos is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income attributable to Leidos shareholders at this time. The amounts of these deductions may be material and, therefore, could result in projected net income attributable to Leidos shareholders and diluted EPS being materially less than projected adjusted EBITDA margins and non-GAAP diluted EPS.

Conference Call Information

Leidos management will discuss operations and financial results in an earnings conference call beginning at 8:00 A.M. eastern time on November 2, 2021. Analysts and institutional investors may participate by dialing +1 (877) 869-3847 (toll-free U.S.) or +1 (201) 689-8261 (international callers).

A live audio broadcast of the conference call along with a supplemental presentation will be available to the public through links on the Leidos Investor Relations website (View Source).

After the call concludes, an audio replay can be accessed on the Leidos Investor Relations website or by dialing +1 (877) 660-6853 (toll-free U.S.) or +1 (201) 612-7415 (international callers) and entering conference ID 13723845.

On November 1, 2022 VCN Biosciences, a clinical–stage company developing oncolytic immuno-oncology products reported the publication of data from the Clinical Trial P-VCNA-002 conducted in patients with Pancreatic Cancer that received VCN-01 by intratumorally administration (Press release, VCN Biosciences, NOV 1, 2022, View Source [SID1234606778]). The paper appears in Peer-Reviewed Journal of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Highlights from the article include:

➢ Treatment based in three intratumoral doses of VCN-01 is generally well-tolerated.

➢ VCN-01 treatment results in disease stabilization of injected lesions.

➢ VCN-01 is detected in blood as secondary peaks and in post-treatment tumor biopsies, indicating active virus replication.

➢ Patients present increasing levels of hyaluronidase in sera over time which confirm sustained intratumor VCN-01 replication

➢ VCN-01 decreases tumor stiffness in pancreatic patients, suggesting stromal disruption

Manel Cascalló, CEO of VCN Biosciences, said, "We are very excited to publish our clinical data obtained with VCN-01 by intratumor route in patients with pancreatic cancer. The product has demonstrated a good safety profile when combined with the standard chemotherapy for this tumor type, and we have been preliminary evidence of its capacity to control the growth of this extremely aggressive tumor. Although this trial was designed as a Proof of Concept study, it has allowed to confirm the mechanism of action of VCN-01 in the clinicals setting. We also want to thank patients and families for their willingness to participate in the clinical trial."

The publication is now available electronically at: VCN-01 disrupts pancreatic cancer stroma and exerts antitumor effects | Journal for ImmunoTherapy of Cancer (bmj.com)

On November 1, 2021 Patrys has reported a $7.8 million capital raising via a Placement and fully underwritten Rights Issue (Press release, Patrys, NOV 1, 2021, View Source [SID1234605548]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

These funds will significantly strengthen Patrys’ balance sheet, providing for:

Initiation of a formal development program for PAT-DX3, Patrys’ full-sized IgG deoxymab antibody, that is expected to provide Patrys with additional development and partnering opportunities;
Development of a manufacturing process to provide clinical‑grade PAT-DX3 at commercial scale including establishing a stable, high-yielding producer cell line.
Further R&D studies including use of deoxymabs for targeted delivery to support potential inhouse and partnered programs for antibody drug conjugates (ADCs);
Expansion of the Company’s business development activities, working capital, corporate activities, and offer costs.
Territory Funds Management has strongly supported this capital raise and we are pleased to offer existing shareholders an opportunity to invest in this exciting growth opportunity too via the fully underwritten 1:12 Rights Issue.