Washington braces for its first potential government shutdown under House Speaker Kevin McCarthy’s speakership as the fiscal year-end nears on September 30. The high-stakes funding clash represents an early test of McCarthy’s ability to lead a fractious Republican majority.
The face-off caps months of growing friction between McCarthy and the hardline House Freedom Caucus that helped install him as Speaker in January. To gain their votes, McCarthy pledged he would not advance spending bills without “majority of the majority” Republican backing.
That concession has now put McCarthy in a bind as the shutdown deadline approaches without a funding agreement in place. The Freedom Caucus is demanding McCarthy leverage the must-pass spending legislation to cut budgets and advance conservative policies, like defunding the FBI.
However, McCarthy knows Senate Democrats would never accept such ideological provisions. And a prolonged government shutdown could batter the fragile economy while eroding public faith in governance competence.
With only days remaining, McCarthy weighs risky options without easy solutions. Scheduling a vote on a stripped-down continuing resolution to temporarily extend current funding would break his promise to the Freedom Caucus.
Yet refusing to hold a vote risks blame for an unpopular shutdown. McCarthy also considers putting a Senate-passed funding bill to a House floor vote, prompting Freedom Caucus warnings that doing so would incite calls for his ouster.
The Speaker urgently needs to unify Republicans behind a way forward. But McCarthy must balance the Freedom Caucus’ demands against the consequences of failing to avert a shutdown.
Navigating these pressures will test McCarthy’s ability to govern a narrow 222-seat majority. It will also gauge whether he can effectively steer the party into the 2024 elections amid internal divisions.
With only 18% of Americans supporting shutdowns over policy disputes according to polls, McCarthy likely wants to avoid a disruptive funding lapse. A 2013 closure lasting 16 days is estimated to have shaved 0.2-0.6% from economic growth that quarter.
From furloughing 800,000 federal workers to suspending services, even a short shutdown could batter public trust in leadership. The military’s over 1.3 million active duty members would see pay disrupted. National Parks could close, impacting over 297 million annual visitors.
The high-risk brinkmanship highlights the difficulty McCarthy faces satisfying the party’s warring moderate and Freedom Caucus wings. Finding a solution that keeps government open while saving face with hardliners will prove a true test of McCarthy’s political dexterity.
Past shutdowns under divided government have tended to end once public pressure mounted on the blamed party. While Republicans control the House, most fault would land on them for manufacturing a crisis.
Yet McCarthy cannot disregard the Freedom Caucus, whose backing enabled his ascension to power. The days ahead will reveal whether McCarthy has the savvy to extricate the GOP from a crisis partly of its own making.
McCarthy’s handling of the funding impasse will set the tone for his entire speakership. At stake is nothing less than his ability to govern, deliver on promises, and prevent self-inflicted wounds entering 2024.
Allient Inc. (Nasdaq: ALNT), a designer and manufacturer of specialty motion control products, has acquired Sierramotion Inc., a private company specializing in precision motion solutions. The deal expands Allient’s capabilities in highly-engineered motion components for robotic, medical, industrial and other applications.
California-based Sierramotion brings decades of experience designing customized electro-mechanical systems. Their expertise spans rotary, linear and arc motion applications. Sierramotion provides rapid prototyping, testing and low volume manufacturing for customers across industries like semiconductor, defense and robotics.
The acquisition aligns with Allient’s strategy of adding new technologies through M&A. Sierramotion’s engineering talent and nimble product development will aid Allient’s push into integrated motion systems. Combined with Allient’s larger scale manufacturing footprint, the deal creates opportunities to commercialize Sierramotion’s innovations.
Allient sees motion control as a high-growth market driven by automation and electrification trends. Their targeted sectors include factory automation, surgical robotics, last-mile delivery, drones and electric vehicles. Allient aims to leverage acquisitions to expand capabilities across this diverse customer base.
The addition of Sierramotion also boosts Allient’s new product development capacity, speeding time-to-market. Quick turn prototyping and close customer collaboration helps Sierramotion rapidly refine motion components. Integrating these strengths with Allient’s global manufacturing creates a competitive advantage.
Founded in 2019, Sierramotion has worked previously with Allient to co-develop motion solutions. The existing relationship and complementary capabilities make for a seamless integration of the two companies per management. Expect the deal to be immediately accretive.
Allient continues executing on a well-defined acquisition strategy aimed at shareholder value creation. The company looks for targets that expand its motion technology portfolio and bring specialized engineering talent. Disciplined capital deployment and operating excellence remain priorities for the Buffalo, NY-based firm.
Sierramotion also offers entry into growing West Coast technology hubs. The acquisition provides a footprint near potential customers across tech sectors. Overall, the deal enhances Allient’s competitive positioning within precision motion control, a key focus area for the company.
Keep an eye out for new motion control products as Allient leverages Sierramotion’s unique capabilities. The merger kicks Allient’s acquisition-driven expansion into higher gear as management vows to seize opportunities and lead innovation.
Regeneron Pharmaceuticals has expanded its gene therapy programs by acquiring Decibel Therapeutics, a biotech company focused on developing treatments for hearing loss. The $1.1 billion deal provides Regeneron with three promising gene therapy candidates that use adeno-associated virus (AAV) vectors to restore hearing.
The most advanced asset is DB-OTO, an AAV-based gene therapy designed to provide long-term hearing to individuals with profound congenital hearing loss caused by otoferlin gene mutations. DB-OTO is currently being evaluated in a Phase 1/2 clinical trial known as CHORD. The gene therapy aims to deliver a functional copy of the otoferlin gene to inner ear hair cells, potentially enabling hearing restoration.
The acquisition also includes two earlier-stage gene therapies, AAV.103 and AAV.104, targeting other genetic forms of hearing loss – GJB2 and STRC respectively. Both utilize a similar AAV gene delivery approach to DB-OTO.
According to Regeneron, the addition of Decibel’s pipeline and capabilities will strengthen its genetic medicines portfolio. Gene therapy has become a major focus for Regeneron beyond its foundational expertise in antibodies. The company is exploring gene silencing, gene editing and gene therapy technologies across a range of therapeutic areas.
Hearing loss represents a new area for Regeneron, building on an existing collaboration with Decibel. Integration of Decibel’s team and experience in inner ear biology and AAV gene therapy for hearing disorders will be invaluable as Regeneron advances the acquired programs.
Gene therapy aims to address disease at its genetic root cause by introducing functional genes into cells. The goal is to durably restore protein expression and correct the downstream impacts of gene mutations. Gene therapy has shown promise for treating rare monogenic disorders like certain forms of inherited hearing loss.
Both Regeneron and Decibel have utilized AAV vectors to deliver gene therapy payloads. AAV is considered one of the most effective vehicles for gene delivery and has an established safety profile. The viruses can be engineered to target specific cell types following injection into the body.
For DB-OTO, the AAV vector carries a functional copy of the otoferlin gene. Inner ear hair cells are the targets for gene transduction. Otoferlin protein is critical for hearing signal transduction, but mutations in the encoding gene cause profound congenital deafness. Gene therapy aims to restore otoferlin expression and regain hearing function.
Regeneron’s push into gene therapy aligns with its mission of tackling serious diseases with novel technologies. Gene-based treatments have potential for one-time curative therapies. The acquisition of Decibel’s pipeline further diversifies Regeneron’s genetic medicine capabilities as it aims to help patients worldwide.
Landmark cardiac xenotransplantation procedure conducted at University of Maryland Medical Center
Tegoprubart, administered investigationally to prevent organ rejection post-transplant, targets the CD40L pathway known to play an essential role in both innate and adaptive immune cell activation and function.
IRVINE, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40 antibody, was used as a cornerstone component of the chronic immunosuppressive regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human. The procedure was completed on September 20th at University of Maryland Medical Center on a 58-year-old male suffering from heart failure.
“This is a momentous milestone for the transplant community and serves as a testament to the continued progress being made towards advancing novel treatment options for patients requiring an organ transplant,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “As the field of organ transplantation continues to make important scientific advances, Eledon is dedicated to delivering a novel immunosuppressive regimen with the potential to protect and prevent rejection of transplanted organs, and we are honored to play a role in this historic development.”
Following the successful transplantation, tegoprubart was administered to the patient as a novel, key component of a chronic immunosuppressive regimen designed to suppress the immune system and prevent the body from rejecting the implanted organ. In prior clinical research, tegoprubart has demonstrated a favorable safety and tolerability profile across multiple indications, including kidney transplantation, as well as clinical benefit in the prevention of rejection and the protection of organs after transplantation.
“The historic procedure we conducted on our courageous patient brings us to a pivotal moment in the history of organ transplantation. It is also a critical step in our ongoing mission to address the growing shortage of available organs,” said Muhammad M. Mohiuddin, MD, professor of surgery at University of Maryland School of Medicine (UMSOM) and scientific/program director of its Cardiac Xenotransplantation Program. “The ability to expand options in all areas including access to available organs and strategies to reduce the risk of rejection means that we are getting closer to realizing the full potential of transplantation for patients. I look forward to continued advancements so that we can hopefully make xenotransplantation an available organ source for patients in the years ahead.”
Eledon is advancing multiple research efforts related to the use of tegoprubart to reduce the risk of rejection in organ transplant. In collaboration with eGenesis, the company is currently advancing preclinical studies in which tegoprubart will be administered as part of an immunosuppression regimen to reduce the risk of rejection in nonhuman primate recipients in xenotransplant procedures. The company recently announced initiation of patient dosing in the phase 2 BESTOW clinical trial to further assess the use of tegoprubart in kidney transplantation and expects to present an updated readout from its ongoing phase 1b kidney transplantation study in November 2023. BESTOW is a head-to-head superiority study evaluating tegoprubart vs. standard of care in kidney transplantation, with a primary endpoint assessment of kidney graft function (eGFR) at 52 weeks.
The Risk of Organ Failure in Transplantation
In transplantation procedures, organ rejection is a major cause of graft failure which can be a life-threatening condition. To reduce the risk of organ damage and rejection, patients are typically treated with immunosuppressive therapies including calcineurin inhibitors (CNIs) such as tacrolimus. Strategies to better and more safely protect transplanted organs and thus increase how long they function represent a significant area of unmet need in organ transplantation.
About Eledon Pharmaceuticals and Tegoprubart (formerly AT-1501)
Eledon Pharmaceuticals is a clinical stage biotechnology company with immunology expertise that is developing therapies to protect and prevent rejection of transplanted organs, as well as to treat amyotrophic lateral sclerosis (ALS). The Company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand (also called “CD154”), a well-validated biological target with broad therapeutic potential. Eledon is headquartered in Irvine, California. For more information, please visit the company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about planned clinical trials and the Company’s other future expectations, plans and prospects, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Event to be held on Tuesday, October 3 from 8:00 to 9:00 AM EDT
PRINCETON, N.J., Sept. 25, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced that its Key Opinion Leader (KOL) Roundtable on Addressing Current and Future Treatments for Recurrent/Metastatic Human Papillomavirus (HPV)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC) and the Potential Application of PDS0101 will now take place on Tuesday, October 3, 2023, from 8:00 – 9:00 AM EDT, due to a scheduling conflict. The event was originally scheduled for Wednesday, September 27, 2023.
The event will be moderated by PDS Biotech’s Chief Medical Officer, Dr. Lauren V. Wood, and will feature presentations from the following head and neck cancer KOLs:
Dr. Glenn Hanna, Assistant Professor, Harvard University and Medical Oncologist, Dana-Farber Cancer Institute
Dr. John Kaczmar, Associate Professor, Medical University of South Carolina
Dr. Ricard Mesía, Head of Medical Oncology, Catalan Institute of Oncology
Dr. Katharine Price, Associate Professor, Oncology Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center
Registration for the event is open. A live webcast of the event will be available online in the Investor Relations section of the Company’s website at https://www.pdsbiotech.com/index.php/investors. A replay will be available for 90 days following the webcast.
About PDS Biotechnology PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
Forward Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.
Continues Momentum to Increase Utilization Through Existing and New Contracts
BRENTWOOD, Tenn., Sept. 25, 2023 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (“CoreCivic”) announced today it signed a new management contract with Hinds County, Mississippi for up to 250 adult male pre-trial detainees at the Company’s 2,672-bed Tallahatchie County Correctional Facility in Tutwiler, Mississippi. The initial contract term is for two years, which may be extended for an additional year upon mutual agreement.
Damon T. Hininger, President and Chief Executive Officer commented, “We are pleased to enter into a new management contract with Hinds County and are honored to be entrusted with the care of a portion of their detainee population.”
CoreCivic currently cares for residents at the Tallahatchie County Correctional Facility from the United States Marshals Service, Vermont, South Carolina, the U.S. Virgin Islands, and Tallahatchie County.
Hininger continued, “We continue to see increasing demand for our correctional and detention solutions, evidenced by the new contract with Hinds County. The Tallahatchie County Correctional Facility is a flexible facility, which has capacity to accommodate additional government customers. We have been in discussions with additional federal, state, and local government agencies to utilize capacity in numerous of our facilities, including at the Tallahatchie facility. We have recently accepted approximately 160 additional residents from the state of Idaho under an existing contract at our Saguaro Correctional Facility in Arizona to meet their increasing needs. We have also recently signed contract extensions with the state of Vermont at the Tallahatchie facility, which was scheduled to expire September 30, 2023, with U.S. Immigration & Customs Enforcement at our Elizabeth Detention Center in New Jersey, and with the Texas Department of Criminal Justice for five residential reentry centers in Texas, all of which expired August 31, 2023, and with the state of Montana at our Crossroads Correctional Center in Montana, which expired June 30, 2023.”
About CoreCivic
CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and one of the largest prison operators in the United States. We have been a flexible and dependable partner for government for 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.
Forward-Looking Statements
This press release contains statements as to our beliefs and expectations of the outcome of future events that are “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made. These include, but are not limited to, the risks and uncertainties associated with: (i) changes in government policy, legislation and regulations that affect utilization of the private sector for corrections, detention, and residential reentry services, in general, or our business, in particular, including, but not limited to, the continued utilization of our correctional and detention facilities by the federal government, including as a consequence of the United States Department of Justice, or DOJ, not renewing contracts as a result of President Biden’s Executive Order on Reforming Our Incarceration System to Eliminate the Use of Privately Operated Criminal Detention Facilities, impacting utilization primarily by the BOP and the United States Marshals Service, and the impact of any changes to immigration reform and sentencing laws (we do not, under longstanding policy, lobby for or against policies or legislation that would determine the basis for, or duration of, an individual’s incarceration or detention); (ii) our ability to obtain and maintain correctional, detention, and residential reentry facility management contracts because of reasons including, but not limited to, sufficient governmental appropriations, contract compliance, negative publicity and effects of inmate disturbances; (iii) changes in the privatization of the corrections and detention industry, the acceptance of our services, the timing of the opening of new facilities and the commencement of new management contracts (including the extent and pace at which new contracts are utilized), as well as our ability to utilize available beds; (iv) general economic and market conditions, including, but not limited to, the impact governmental budgets can have on our contract renewals and renegotiations, per diem rates, and occupancy; (v) fluctuations in our operating results because of, among other things, changes in occupancy levels; competition; contract renegotiations or terminations; inflation and other increases in costs of operations, including a continuing rise in labor costs; fluctuations in interest rates and risks of operations; (vi) the impact resulting from the termination of Title 42, the federal government’s policy to deny entry at the United States southern border to asylum-seekers and anyone crossing the southern border without proper documentation or authority in an effort to contain the spread of the coronavirus and related variants, or COVID-19; (vii) our ability to successfully identify and consummate future development and acquisition opportunities and realize projected returns resulting therefrom; (viii) our ability to have met and maintained qualification for taxation as a real estate investment trust, or REIT, for the years we elected REIT status; and (ix) the availability of debt and equity financing on terms that are favorable to us, or at all. Other factors that could cause operating and financial results to differ are described in the filings we make from time to time with the Securities and Exchange Commission.
We take no responsibility for updating the information contained in this press release following the date hereof to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events or for any changes or modifications made to this press release or the information contained herein by any third-parties, including, but not limited to, any wire or internet services.
Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Price Momentum. LWAY shares continue their rise, closing last Friday at $12.42, above our recently raised $12 price target. LWAY shares are up 97% since closing at $6.30 the Friday before the August 14th 2Q23 earnings release and are up nearly 124% YTD. Notably, volume continues to show strong momentum, with the ADV since August 14 at 136,522 shares, compared to a 90 day ADV of 15,430 shares just prior to the August 14th earnings release.
Rationale. With the sharp price rise, LWAY shares are likely to enter a consolidation phase, in our view. Further significant price appreciation leans towards operating results exceeding expectations and/or a potential acquisition of the Company, in our view. With insiders controlling nearly 50% of the outstanding shares, we do not believe a sale of the Company is in the cards.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Haynes International, Inc. is a leading developer, manufacturer and marketer of technologically advanced, nickel and cobalt-based high-performance alloys, primarily for use in the aerospace, industrial gas turbine and chemical processing industries.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Updating estimates. We have lowered our fiscal year 2023 EBITDA and EPS estimates to $81.2 million and $3.25 per share from $82.0 million and $3.30 per share. Our estimates reflect lower gross margins during the September quarter due to the negative impact of raw material fluctuations, primarily for nickel and cobalt. We have reduced our 2024 EBITDA and EPS estimates to $104.3 million and $4.50 per share from $106.8 million and $4.65. Our revised 2024 estimates reflect seasonality and more conservative sales volume growth assumptions albeit at modestly higher margins. The first quarter of each fiscal year is typically Haynes’ lowest revenue and earnings quarter due in part to holidays and planned maintenance.
Strong order backlog. Orders during the June quarter resulted in a record backlog of $468.1 million and represented a 4.8% increase compared to the prior quarter and a 38.4% increase on a year-over-year basis. Backlog pounds increased 3.2% during the third quarter to approximately 14.6 million pounds and increased 20.7% compared to the prior year period driven by strong demand in the aerospace and industrial gas turbine markets. In our view, the strong order book is indicative of the company’s strong competitive position and favorable outlook.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
GEO-CM04S1Phase 2 Clinical and Preclinical Data Show Efficacy. GeoVax announced publication of initial Phase 2 data from the CM04S1 trial in immunocompromised patients that showed significant immune responses. A poster presentation at a medical meeting showed preclinical data on CM04S1 efficacy against multiple variant strains. We believe both publications support our expectations that CM04S1 can effectively stimulate both humoral and cellular immunity.
Initial Responses Seen In Immunocompromised Patients. GeoVax announced the publication of initial data from its Phase 2 trial for GEO-CM04S1 in immunocompromised patients with hematological malignancies in the journal Vaccines. The data showed both humoral and cellular immune responses in patients with reduced immune function that have difficulty responding to vaccination. The immune markers were superior or comparable to historical cohorts from healthy patients receiving the Pfizer mRNA vaccine.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
E-commerce titan Amazon is making a huge investment into artificial intelligence startup Anthropic, injecting up to $4 billion into the budding firm. The massive funding underscores Amazon’s ambitions to be a leader in next-generation AI capabilities.
Anthropic is a two-year old startup launched by former executives from AI lab OpenAI. The company recently introduced its new chatbot called Claude, designed to converse naturally with humans on a range of topics.
While Claude has similarities to OpenAI’s popular ChatGPT, Anthropic aims to take natural language AI to the next level. Amazon’s investment signals its belief in Anthropic’s potential to pioneer groundbreaking generative AI.
Generative AI refers to AI systems that can generate new content like text, images, or video based on data they are trained on. The technology has exploded in popularity thanks to ChatGPT and image generator DALL-E 2, sparking immense interest from Big Tech.
Amazon is positioning itself to capitalize on this surging interest in generative AI. As part of the deal, Amazon Web Services will become Anthropic’s primary cloud platform for developing and delivering its AI services.
The startup will also let AWS customers access exclusive features to customize and fine-tune its AI models. This tight integration gives Amazon a competitive edge by baking Anthropic’s leading AI into its cloud offerings.
Additionally, Amazon will provide custom semiconductors to turbocharge training for Anthropic’s foundational AI models. These chips aim to challenged Nvidia’s dominance in supplying GPUs for AI workloads.
With its end-to-end AI capabilities across hardware, cloud services and applications, Amazon aims to be the go-to AI provider. The Anthropic investment caps off a flurry of activity from Amazon to own the AI future.
Recently, Amazon unveiled Alexa Voice, AI-generated voice assistant. The company also launched Amazon Bedrock, a service enabling companies to easily build custom AI tools using Amazon’s machine learning models.
And Amazon Web Services already offers robust AI services like image recognition, language processing, and data analytics to business clients. Anthropic’s generative smarts will augment these solutions.
The race to lead in AI accelerated after Microsoft’s multi-billion investment into ChatGPT creator OpenAI in January. Google, Meta and others have since poured billions into AI startups to not get left behind.
Anthropic has already raised funding from top tier backers like Google’s VC arm and Salesforce Ventures. But Amazon’s monster investment catapults the startup into an elite group of AI startups tapping into Big Tech’s cash reserves.
The deal grants Amazon a minority stake in the startup, suggesting further collaborations ahead. With Claude 2 generating buzz, Anthropic’s next-gen AI technology and Amazon’s vast resources could be a potent combination.
For Amazon, owning a piece of a promising AI startup hedges its bets should generative AI disrupt major industries. And if advanced chatbots like Claude reshape how customers interact with businesses, Amazon is making sure it has skin in the game.
The e-commerce behemoth’s latest Silicon Valley splash cements its position as an aggressive AI player not content following others. If Amazon’s bet on Anthropic pays off, it may pay dividends in making Amazon a go-to enterprise AI powerhouse.
Microsoft’s proposed $68.7 billion acquisition of Activision Blizzard has the potential to completely transform the gaming landscape. While regulators have scrutinized the deal over competition concerns, the merger could bring tremendous benefits to Microsoft, Activision, and the broader video game industry.
For Microsoft, owning Activision Blizzard will expand its catalog of exclusive titles and strengthen its position in the rapidly growing cloud and mobile gaming markets. Activision’s stable of popular franchises, including Call of Duty, World of Warcraft, and Overwatch, will give Microsoft’s Xbox platform exclusive access to some of the most iconic brands in gaming.
The deal also bolsters Microsoft’s Game Pass subscription service. By adding Activision games into the Game Pass library, Microsoft could attract millions of new subscribers. Game Pass now has over 25 million subscribers, and Activision’s titles provide strong incentive for even more gamers to sign up.
Microsoft also aims to leverage Activision’s titles to boost its cloud gaming efforts. Cloud gaming allows players to stream games over the internet, without needing expensive hardware. Microsoft’s Project xCloud trails behind competitors, but owning rights to Activision’s diverse lineup of games could help close the gap with rivals.
For Activision Blizzard, the deal provides much-needed stability after a rocky couple of years. The company faced intense backlash over allegations of sexual harassment and discrimination against female employees. Activision also lost favor with gamers over accusations of declining game quality. Joining forces with Microsoft gives Activision renewed focus along with the resources to potentially revitalize its culture and game development efforts.
The merger can also reinvigorate Activision’s floundering esports leagues. Microsoft brings immense expertise in managing leagues like the NBA 2K League. With dedicated support, Activision’s Overwatch League and Call of Duty League can get back on track to engage fans.
More broadly, the deal validates the tremendous growth potential of the $200 billion gaming market. Investors originally balked at the $68.7 billion price tag, which was nearly a 50% premium over Activision’s market value. However, Microsoft likely sees this as a long-term investment, as analysts forecast the gaming sector to expand to over $300 billion by 2027.
While there are understandable concerns about one company gaining so much influence, Microsoft has committed to keeping Activision games available across multiple platforms. The tech giant also faces strong incentives to continue investing in blockbuster franchises like Call of Duty rather than making them Xbox exclusives.
After months in limbo, the deal now appears to be back on track for completion in late 2023 or early 2024. Assuming it passes the final regulatory hurdles, this acquisition has the scope to reshape gaming for players and developers alike. By bringing together two titans of the industry, the new Microsoft-Activision partnership could help unlock gaming’s true potential.
Abpro, an emerging biotechnology company developing novel antibody therapies, has entered into a definitive agreement to go public via a merger with Atlantic Coastal Acquisition Corp. II, a special purpose acquisition company (SPAC). The deal values Abpro at $725 million and will provide capital to advance its drug pipeline.
Abpro specializes in leveraging its proprietary technology platform to create next-generation antibody treatments for cancer, eye diseases, and viral infections. The company aims to develop breakthrough immunotherapies to help patients facing life-threatening conditions.
Though Abpro is still in the preclinical phase, it has made significant progress with its pipeline of antibody therapies. Its lead candidates target HER2+ cancers, which include aggressive forms of breast, gastric, and colorectal cancer. Abpro is also pursuing antibodies for COVID-19 treatment and ophthalmic conditions like wet AMD and DME.
Last year, Abpro announced a partnership with South Korea’s Celltrion to further develop ABP 102, an antibody-based treatment for HER2+ cancers. Under the deal, Abpro received a direct equity investment from Celltrion along with eligibility for up to $1.75 billion in milestone payments.
Abpro leverages its DiversImmune platform to design diverse antibody libraries and identify optimal drug candidates. The technology enables more precise targeting compared to conventional antibodies.
The merger with Atlantic Coastal will provide capital for Abpro to advance its most promising therapies into clinical studies. Abpro also plans to use the funds for business development activities and expanding its pipeline.
Atlantic Coastal is a SPAC focused on finding and merging with high-potential healthcare companies. The transaction is expected to close in Q2 2024, at which point the combined company will trade publicly.
Commenting on the merger, Abpro CEO Ian Chan stated: “This milestone will accelerate getting our therapies to patients needing life-changing treatments.”
Abpro represents an attractive investment opportunity within biotech. Analysts project the global antibody technology market to reach $272 billion by 2030, driven by rising demand for targeted immunotherapies. With its next-generation platform and infusion of growth capital, Abpro is well-positioned to compete in this thriving sector.
The transaction comes amidst a wave of biotech SPAC deals, as pre-revenue companies aim to access public growth financing. With its proprietary technology and strategic partnership in place, Abpro seems poised to leverage this deal to evolve from an R&D startup into a fully integrated biopharma company.
Explore other SPAC Mergers via Spactrac reports from Noble Capital Markets
Over the past year, large cap stocks have vastly outperformed their small cap counterparts. This widening rift between the biggest and smallest public companies has reached extremes not seen in over 20 years. While large caps continue charging ahead, small caps face mounting challenges that threaten their role in a balanced investment portfolio.
The stark contrast is evident in the returns of two major indices. The S&P 500, comprised of 500 of the largest U.S. companies, has delivered over -15% returns over the past 12 months. Meanwhile the Russell 2000 small cap index plunged over -25% over the same period.
This nearly 10 percentage point gap represents the highest divergence between large and small caps since 2001. The lopsided returns conjure memories of the late 1990s dot-com bubble, when mega cap tech stocks left smaller companies in the dust.
However, the current environment contains even stronger headwinds against small caps. Rampant inflation has battered small companies, which lack the pricing power of large cap brands. Ongoing supply chain difficulties and labor shortages have also taken a heavier toll on small business.
Moreover, the Federal Reserve’s aggressive interest rate hikes to combat inflation have disproportionately impacted small caps. Not only are borrowing costs up, but higher rates dampen economic growth forecasts which small caps rely upon. With the Fed signaling even more hikes ahead, the path ahead looks rocky.
Large caps have also benefitted from a flight to quality. Investors have piled into mega cap stocks like Apple, Microsoft, and Procter & Gamble as safe havens amid volatile markets. These stalwarts deliver steady revenues and dividends that provide shelter from broader economic storms.
The growth versus value dynamic has also disadvantaged small caps. With recession fears looming, investors have favored large cap stocks of mature companies over risky, high-growth small caps. Additionally, large tech names like Amazon and Nvidia dominate future-facing themes like cloud computing, AI, and the metaverse.
Some analysts argue this gap has created a bubble, with popular large caps trading at overextended valuations. However, until inflation shows meaningful declines, small caps will likely continue struggling against their mega cap peers.
For investors, the uneven returns underscore the importance of diversification between company sizes. While small caps carry higher risks today, they historically deliver long-term outperformance. Once the economy stabilizes, the pendulum could swing back in favor of smaller dynamos. For those with the risk tolerance, small caps trading at multi-year discounts could offer an opportunity.
Looking ahead, economic uncertainty persists. But maintaining exposure across the market cap spectrum remains imperative. Having allocation to both large and small caps allows investors to weather various market cycles. With patience and prudence, this lopsided period will eventually balance out.
