Author: Mahnoor Shah

JAWS Spitfire Acquisition Corp. (NASDAQ: SPFR) stock declined by 14.31% at the last close whereas the SPFR stock price rises by 6.04% in the pre-market trading session. JAWS Spitfire Acquisition Corporation was a blank check company formed as a Cayman Islands excluded company with the aim of impacting a merger, share exchange, purchase of assets, share purchase, restructuring, or similar business combination with one or more companies or entities before the business combination.

SPFR stock’ Current Update

Velo3D, a premier additive manufacturing technology company specialising in mission-critical metal components, has finalized its merger with JAWS Spitfire Acquisition Corporation and is now publicly listed. On September 30, 2021, the merged business will be known as Velo3D, and its common stock and warrants will start trading on the New York Stock Exchange under the ticker symbol “VLD” and “VLD WS,” respectively.

The corporate combination was authorised by JAWS Spitfire’s board of directors, as well as a special meeting of the company’s shareholders on September 28, 2021. The merged business acquired about $274 million in total net proceeds as a consequence of this transaction, including $155 million in a private issue of common stock valued at $10.00 per share.

Velo3D’s end-to-end additive manufacturing solutions are likely to benefit from the revenues. The company’s projected expansion into Europe, which will be a significant market in 2022, is part of this growth.

Benny Buller, Founder, and CEO at Velo3D stated,

Velo3D has reached a significant milestone. The company’s mission has always been to empower their customers to create without compromise, and the funds obtained from this combination will help them usher in a new age of advanced manufacturing innovation. The end-to-end solution has the potential to change industries and contribute to the formation of previously unimaginable technologies. They think they have a huge potential ahead of them, and that their unique skills will drive fast acceptance of their technology and future growth.

Broadwind Energy Inc. (NASDAQ: BWEN) stock fell by 4.28% at last close whereas the BWEN stock-price surges by 11.79% in the pre-market trading session. Broadwind is a high-precision manufacturer of clean-tech and other specialty buildings, equipment, and components. Their experienced staff is dedicated to helping clients optimise the performance of their investments, quicker, simpler, and smarter with locations around the United States.

BWEN stock’ Important Development

Broadwind stated that it has secured new tower orders totaling more than $12 million from a variety of wind turbine clients. Broadwind has sold around a quarter of its full-year 2022 optimum tower manufacturing capacity, including these additional orders. In the next months, Broadwind hopes to get more orders for manufacturing capacity in 2022.

Eric Blashford, President and CEO of Broadwind stated that,

As they think forward to 2022, these additional tower orders give improved visibility while also strengthening their connections with important wind turbine partners. They estimate tower demand to start to increase in 2022, owing to continued success in client diversification, increasing order activity, and the likely approval of a production tax credit extension. They expect sequential order growth of 50% in the third quarter of 2021, compared to the second quarter, due to increased activity levels across all of their reporting divisions. During their third quarter conference call in early November, they will provide more updates.

Recent Update about Management

Jason Bonfigt, Vice President and Chief Financial Officer, informed the Board of Directors of his intention to seek other possibilities, according to Broadwind. Mr. Bonfigt’s departure has nothing to do with the Company’s operations, policies, or procedures, including internal controls or financial concerns.

Since July 2017, Mr. Bonfigt has worked as Chief Financial Officer of Broadwind, which he joined in 2008. Mr. Bonfigt will remain in his present role until October 1, 2021, when President and CEO Eric Blashford will take on the job of interim Chief Financial Officer.

Conformis Inc. (NASDAQ: CFMS) stock declined by 4.44% at the last close whereas the CFMS stock price gains by 3.1% in the after-hours trading session. Conformis is a medical technology company that develops, manufactures, and sells joint replacement implants and instruments that are separately sized and shaped, also known as personalised, individualised, or customised, to fit and ensure adherence to each person’s specific anatomy using its proprietary iFit Image-to-Implant technology platform.

CFMS stock’ Update

Conformis today revealed the positive findings of a retrospective analysis of operations performed using Conformis’ patient-specific iTotal CR (cruciate-retaining) knee replacement implant, which looked at implant survival, patient satisfaction, and functional outcomes.

The clinical study’s main findings are as follows:

• At a mean follow-up of 2.8 years, implant survival was 98.5 percent, with 8 revisions (representing 1.5 percent of the 540 implants examined) (ranging from one month to seven years post-surgery).
• Patient Satisfaction – 89 percent of patients said they were pleased or very satisfied with their care.
• Functional Results — The Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR) questionnaire yielded a strong mean score of 82 (range: 34-100).

Furthermore,

The researchers examined patient records and performed patient report outcome surveys on 540 knees in 433 patients who underwent personalised total knee arthroplasty at Personalized Orthopaedics of the Palm Beaches in Boynton Beach, Florida, performed by Dr. Gregory Martin, a U.S. board-certified orthopaedic surgeon. The demographics of the patients, surgical factors, complications, and re-operations were all taken into account. To measure survival, patient satisfaction, and functional results, follow-up evaluations were conducted via a single phone call.

Mark Augusti, President, and CEO of Conformis stated,

This research was one of the biggest retrospective studies they’ve ever done, and it’s another evidence of how their technology leads to high patient satisfaction, excellent functional results, and long-term implant survival. This is a tribute to their whole organization’s commitment to providing high-quality products to their clients and their patients. This helps their long-term growth plan while reinforcing the mission.

Ideanomics Inc. (NASDAQ: IDEX) stock declined by 6.37% at last close conversely the IDEX stock-price shows gains during after-hour trading by 7.33%. WAVE provides commercial fleet operators with a faster, easier method to expand the range of medium- and massive electric vehicles by deploying a world-leading number of high-power, thoroughly verified inductive charging systems.

IDEX stock’ Significant Update

WAVE, a subsidiary of Ideanomics (NASDAQ: IDEX), has revealed its involvement in a US Department of Energy (DOE) electrified powertrain project to create a 1-megawatt wireless charging system for Class 8 electric vehicles.

Kenworth will work on system design with WAVE and Utah State University as the major beneficiary of the cooperation partnership. WAVE devices will be installed at both ends of a 400-mile regional haul route linking Portland, OR, and Seattle, WA. A specially outfitted Kenworth T680 next-generation battery EV will get 1-megawatt of electricity from roadway-embedded charging pads stationed at selected locations in Seattle and Portland, allowing the truck to exceed its usual 150-mile range and finish the 400-mile journey. The system, which has a 1-megawatt output, intends to charge the T680 batteries in 30 minutes or less.

Furthermore,

WAVE was chosen for the project due to its track record of supplying high-power wireless charging solutions for moderate- and large vehicles. For example, the Antelope Valley Transit Authority in northern Los Angeles County, which recently made a $2.2 million order, runs the country’s biggest battery-electric bus fleet, which is fueled by 12 WAVE wireless chargers spanning a 100-square-mile route.

The WAVE system, which is entirely automated and hands-free, charges cars during planned stops, removing battery range limits and allowing fleets to attain driving ranges comparable to internal combustion engines. Wireless charging systems provide a number of advantages over plug-in charging systems, including lower maintenance, better health and safety, and faster energy connection. In addition, wireless in-route charging allows for longer routes with smaller cells while retaining battery life.

Orion Group Holdings Inc. (NASDAQ: ORN) stock gains by 19.53% during the after-hours trading session. Through its marine and concrete segments, Orion Group Holdings, Inc., a major specialized construction business servicing the infrastructure, industrial, and building sectors, offers services both on and off the sea throughout the continental United States, Alaska, Canada, and the Caribbean Basin.

Construction and dredging services for maritime transportation facilities, marine pipelines, marine environmental structures, dredging of waterways, channels, and ports, environmental dredging, design, and specialist services are provided by the Company’s marine segment.

ORN stock’ Important Development

Orion Group Holdings has received two contracts worth over $200 million for its Marine division. The Florida Department of Transportation (FDOT) has granted the Company a concession for about $125 million to rebuild the State Road 405 Indian River Bridge across the NASA Causeway in Cape Canaveral, Florida. The main entrance to Kennedy Space Center and Cape Canaveral Space Force Center is through this bridge. The project is scheduled to start in the fourth quarter of 2021 and finish in the fourth quarter of 2024.

In addition, the Port of Port Arthur has granted the Company a contract worth about $67 million to build the Berth 6 Expansion Project in Port Arthur, Texas, which would bring substantial berthing space to the Port. The construction is scheduled to start in the fourth quarter of 2021 and finish in the third quarter of 2024.

Mark Stauffer, Orion’s President, and Chief Executive Officer commented,

Orion has a long history of assisting in the modernization and improvement of vital infrastructure. The NASA Causeway project is their fourth bridge contract to be granted recently, and it, including the Berth 6 Expansion, not just adds to their Marine segment’s backlog, but also reinforces Orion’s position as a premier contractor for creating and restoring their nation’s infrastructure.

Virgin Galactic Holdings Inc. (NASDAQ: SPCE) stock plunged by 3.55% at last close whereas the SPCE stock price gains by 10.15%in the after-hour trading session. Virgin Galactic Holdings is a vertically integrated aerospace and space travel firm that uses sophisticated air and space vehicles to explore human spaceflight for private people and researchers.

SPCE stock’ Significant Development

Following the end of an FAA investigation into air traffic control approval and real-time mission notification linked to the Unity 22 flight in July, Virgin Galactic Holdings stated that it has been allowed to conduct FAA-licensed spaceflights. The FAA informed Virgin Galactic that the Company’s proposed remedial steps had been approved, bringing the FAA investigation, which began on August 11, 2021, to a close. They are as follows:

• Calculations have been updated to increase the protected airspace for future trips. Virgin Galactic will have enough protected airspace for a range of possible flight paths during spaceflight missions by selecting a bigger region.
• Additional steps have been added to the Company’s flight procedures to guarantee that mission notifications to FAA Air Traffic Control are received in real-time.

Virgin Galactic is continuing to work on Unity 23’s pre-flight preparations. Please see the Company’s announcement of September 10, 2021, for the most up-to-date information on flight schedules.

Michael Colglazier, CEO of Virgin Galactic, commented,

Their complete approach to spaceflight, comprising of the spaceflight system and test flight programme, is governed by a basic commitment to safety at every level. They commend the FAA’s comprehensive investigation into this matter. The test flight programme is meant to help them improve their processes and procedures over time. As they get closer to the commercial release of my spaceflight experience, the changes to the airspace and real-time mission notification processes will enhance their preparations.

Management Changes

Aparna Chitale, an experienced human resources executive, will enter Virgin Galactic Holdings as its Chief People Officer (CPO) on September 30, 2021. Chitale has more than 20 years of leadership expertise in multi-national organization, where she has expanded and led worldwide teams in both public and private enterprises. She most recently started working at Disney Parks Experiences and Products as Vice President of Human Resources.

Applied Genetic Technologies Inc. (NASDAQ: AGTC) stock plunged by 3.7% at last close whereas the AGTC stock price gains by 2.56% in the pre-market trading session. AGTC is a clinical-stage biotechnology firm focused on discovering genetic treatments for patients suffering from uncommon and debilitating ophthalmic, otologic, and CNS disorders.

AGTC stock’ Important Event

The Fourteenth International Symposium on Retinal Degeneration will feature a presentation of Applied Genetic Technologies Corporation’s current clinical studies in achromatopsia (ACHM) and X-linked retinitis pigmentosa (XLRPc) (RD2021).

• On September 29, 2021, Rachel Huckfeldt, MD, PhD, Assistant Professor of Ophthalmology at Harvard Medical School, will give a presentation titled Twelve-Month Findings from Two Phase 1/2 Clinical Trials of Subretinal Gene Therapy for Achromatopsia in Adults and Low-Dose Pediatrics.
• However the same day, Paul Yang, MD, PhD, Assistant Professor of Ophthalmology at Oregon Health & Science University in Portland, will reveal Twelve-Month Analysis of Macular Structure using Optical Coherence Tomography (OCT) from a Phase 1/2 Clinical trial of Subretinal Gene Therapy Drug AGTC-501 for X-Linked Retinitis Pigmentosa.

AGTC intends to move its ACHM programme to the next level of clinical testing, submitting an End-of-Phase 2 (EOP2) briefing package to the US Food and Drug Administration, creating pivotal readiness testing assays, and arranging clinical trial material manufacturing.

Sue Washer, President and CEO of AGTC stated,

They hope that their scientists will be able to share their findings and analyses with members of the eye health community. They think the findings support the broad use of their AAV technology platform, such as the best-in-class potential of their XLRP treatment candidate and the need for more clinical research into their therapy to cure ACHM.

Dr. Huckfeldt commented,

ACHM is a hereditary disorder resulting from mutations in one of the many genes, along with the CNGB3 or CNGA3 genes that results in non-functioning “cone” photoreceptors that are necessary for accurate vision. It is associated with poor visual acuity, severe light sensitivity, daytime loss of vision, and partial or full loss of colour discrimination. These findings are quite encouraging, and he is excited to share them with my retinal colleagues.

Hepion Pharmaceuticals Inc. (NASDAQ: HEPA) stock declined by 1.9% at last close whereas the HEPA stock-price gains by 5.81% in the pre-market trading session. Hepion Pharmaceuticals is a clinical-stage pharmaceutical business focused on AI-driven therapeutic medication discovery for non-alcoholic steatohepatitis and liver disorders.

HEPA stock’ Recent Past Development

Hepion Pharmaceuticals has released new effectiveness results from its AMBITION Phase 2a clinical study. A total of 43 NASH patients were included in AMBITION, a multicenter, randomised, placebo-controlled, single-blind Phase 2a study. The study’s goal was to look at once-daily oral administration of CRV431 at dosages of 75 mg (n=12) and 225 mg (n=17) as soft gelatin capsules for 28 days in assumed F2 and F3 NASH patients, accompanied by a 14-day safety monitoring period.

All of the AMBITION NASH trial’s main outcomes were fulfilled, as previously stated. Hepion just published new data on biomarkers, alanine aminotransferase, and N-terminal type III collagen pro-peptide (“Pro-C3”), in addition, they also released improved pharmacologic and bioinformatics studies, all of which suggest that CRV431 is efficacious in curing NASH patients.

Stephen Harrison, MD, will present the entire AMBITION study at the next AASLD “The Liver Meeting” in early November 2021.

Hepion’s Chief Medical Officer, Todd Hobbs MD commented,

The decrease in Pro-C3 shown in the AMBITION study brings them in line with NASH results reported by other firms with late-stage NASH treatment candidates. However, significant decreases in Pro-C3 with CRV431 occurred in about 4 weeks, as opposed to several months with other agents.

Hepion’s Senior VP, Clinical Pharmacology & Analytics, Patrick Mayo, stated,

They can conclude two things from these biomarker discoveries. First, as demonstrated by the Pro-C3 alterations on day 42, CRV431 has a long-lasting impact. These findings can be explained by CRV431’s extended terminal half-life, in fact, circulating blood concentrations of CRV431 are still detectable at day 42, despite the fact that drug administration stopped on day 28. Second, they were prepared to implement their machine learning and proprietary AI-POWR to work, after the most recent data they have deduced from their AMBITION study. They’ve been able to build models that can predict who will react to CRV431 proactively.