Tag: Biotechnology

Release – Eledon Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Operating and Financial Results

Posted on by [email protected]

Research News and Market Data on ELDN

March 28, 2024

Enrolled 12 participants in Phase 2 BESTOW trial evaluating tegoprubart for the prevention of kidney rejection

Tegoprubart used as a component of the immunosuppressive treatment regimen following the first-ever transplant of a kidney from a genetically modified pig to a human

Additional data from 11 participants in Phase 1b trial in kidney transplantation demonstrated that tegoprubart was generally safe and well tolerated, successfully prevented rejection and permitted above historical average post-transplant kidney function

IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2023 operating and financial results and reviewed recent business highlights.

“Eledon continues to execute on time and as promised towards our goal of extending the functional life of transplanted organs,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Our latest Phase 1b data further support the potential of tegoprubart to significantly reduce the risk of rejection as well as harmful side effects associated with current standard of care in immunosuppression. In addition to our clinical development progress, tegoprubart was used for immunosuppression in historical kidney and heart pig-to-human xenotransplant procedures. As we advance our clinical program to assess the use of tegoprubart in kidney transplant procedures, we remain committed to supporting groundbreaking advancements that can lead to broader organ availability for patients around the world.”

“Looking ahead, we anticipate completing enrollment of our Phase 2 BESTOW study by the end of the year as we also continue to enroll participants in the second cohort of our Phase 1b study and open-label extension study designed to provide additional insights into tegoprubart’s long-term effectiveness,” continued Dr. Gros. “We look forward to providing updated interim clinical data from both the Phase 1b and open-label studies in the second quarter of this year.”

Fourth Quarter 2023 and Recent Corporate Developments

  • Announced the use of tegoprubart as a component of the immunosuppressive treatment regimen following the first-ever transplant of a kidney from a genetically modified pig to a human. The procedure was completed on March 16, 2024, at Massachusetts General Hospital on a 62-year-old man with end-stage kidney disease.
  • Announced 12th participant enrolled in the Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.
  • Reported updated safety and efficacy data from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of rejection in patients undergoing kidney transplant. Data from 11 participants demonstrated that tegoprubart was generally safe and well-tolerated in patients undergoing kidney transplantation, with aggregate mean estimated glomerular filtration rate (eGFR) above 70 mL/min/1.73m² at all reported time points after 90 days post-transplant. Results were presented at the American Society of Nephrology Kidney Week 2023 Annual Meeting held in Philadelphia, PA in November 2023.
  • Amended Phase 1b trial protocol to add a second cohort, now allowing enrollment of up to 24 trial participants who are undergoing kidney transplantation.
  • Enrolled first patient in a Phase 2 open-label extension (OLE) study, which will evaluate the long-term safety, pharmacokinetics, and efficacy of tegoprubart in participants who have completed one year of treatment in either the ongoing Phase 1b or Phase 2 BESTOW study. The participant completed the Phase 1b study with an eGFR of 91 at one year (day 374).
  • Partnered with the University of Chicago Transplantation Institute to secure financing from the Juvenile Diabetes Research Foundation (JDRF) and The Cure Alliance to fund an investigator sponsored study in pancreatic islet cell transplantation in participants with type 1 diabetes. Tegoprubart treatment will be evaluated for the prevention of transplant rejection.
  • Strengthened leadership team with appointment of Eliezer Katz, M.D., FACS as Chief Medical Officer and strengthened board of directors with appointment of Allan Kirk, M.D., Ph.D. and James Robinson.

Anticipated 2024 Milestones

  • Second quarter 2024: Report updated interim clinical data from the ongoing Phase 1b trial of tegoprubart in kidney transplantation.
  • End of 2024: Complete enrollment in the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
  • 2024: Dose the first islet cell transplant participant for the treatment of type 1 diabetes at the University of Chicago Transplantation Institute.

Fourth Quarter 2023 Financial Results

The Company reported a net loss of $9.6 million, or $0.32 per share, for the three months ended December 31, 2023, compared to a net loss of $58.4 million, or $4.09 per share, for the same period in 2022. The net loss for the three months ended December 31, 2022 includes a non-cash goodwill impairment charge totaling $48.6 million. Excluding the non-cash impairment charge, net loss would be $9.7 million, or $0.68 per share.

Research and development expenses were $7.1 million for the three months ended December 31, 2023, compared to $7.3 million for the comparable period in 2022, a decrease of $0.2 million.

General and administrative expenses were $3.3 million for the three months ended December 31, 2023, compared to $2.8 million for the comparable period in 2022, an increase of $0.5 million.

Full Year 2023 Financial Results

The Company reported a net loss of $40.3 million, or $1.64 per share, for the year ended December 31, 2023, compared to a net loss of $88.0 million, or $6.16 per share, in 2022. The net loss for the year ended December 31, 2022 includes a non-cash goodwill impairment charge totaling $48.6 million. Excluding the non-cash impairment charge, net loss would be $39.3 million, or $2.75 per share.

Research and development expenses were $30.3 million for the year ended December 31, 2023, compared to $27.1 million for the year ended December 31, 2022, an increase of $3.2 million.

General and administrative expenses were $12.7 million for the year ended December 31, 2023, compared to $12.7 million for the year ended December 31, 2022.

The Company ended the year with approximately $51.1 million in cash and cash equivalents and short-term investments, compared to $56.4 million in cash and cash equivalents as of December 31, 2022.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target within the costimulatory CD40/CD40L cellular pathway. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). 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 the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, 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-Qs, 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.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

Release – Unicycive Therapeutics Announces Full Year 2023 Financial Results And Provides Business Update

Posted on by [email protected]

Research News and Market Data on UNCY

March 28, 2024 4:15pm EDT

– Oxylanthanum Carbonate (OLC) Topline Data Expected in Q2 2024 –

– UNI-494 Granted Orphan Drug Designation in Delayed Graft Function of Acute Kidney Injury –

– UNI-494 Phase 1 Single Ascending Dose Portion of Clinical Trial Complete –

LOS ALTOS, Calif., March 28, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the year ended December 31, 2023, and provided a business update.

“The last several months have been extremely productive for Unicycive as we advanced both of our clinical development programs and secured new funding from several leading healthcare institutional investors,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The completion of enrollment in our pivotal OLC clinical trial was a critical achievement as we believe the novel characteristics of oxylanthanum carbonate (OLC) will show its potential as a best-in-class product to treat hyperphosphatemia for patients with chronic kidney disease (CKD) on dialysis. Positive results from the trial will provide the basis to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), and we remain on track with topline data expected from the trial towards the latter part of the second quarter of this year and plan to file the NDA shortly thereafter.”

Dr. Gupta added, “We also made meaningful progress with our second clinical development program, UNI-494, targeting prevention of delayed graft function (DGF) and other conditions related to acute kidney injury. Earlier this month, UNI-494 was granted orphan drug designation by the FDA for the prevention of DGF after kidney transplantation, and we presented new data showing statistically significant results for UNI-494 in a preclinical model of DGF. We successfully completed the single ascending dose (SAD) portion of our Phase 1 clinical trial, and the multiple ascending dose (MAD) portion of the study is currently ongoing. We expect to complete the Phase 1 trial and report the full results in the second half of this year.”

“As we close out National Kidney Awareness Month, we remain inspired to continue our research and development efforts to provide improved therapies for individuals living with kidney disease,” concluded Dr. Gupta.

Key Highlights

  • Completed enrollment in the open-label, single-arm, multicenter, multidose pivotal clinical trial with OLC, a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed to treat hyperphosphatemia in patients with CKD on dialysis.
  • Completed a private placement with new and existing healthcare institutional investors that generated $50 million in gross proceeds to Unicycive.
  • Granted orphan drug designation (ODD) by the FDA to UNI-494 for the prevention of DGF in kidney transplant patients. ODD may provide certain tax credits for qualified clinical trials, exemption of user fees, and the potential for seven years of market exclusivity after approval. UNI-494 is a cytoprotective agent that elicits an ischemic preconditioning effect by activating KATP channels in mitochondria to restore mitochondrial function.
  • Presented new data demonstrating statistically significant results for UNI-494 in a preclinical model of DGF at the 29th International Conference on Advances in Critical Care Nephrology AKI and CRRT 2024. The data provides additional evidence that UNI-494 may be a valuable asset for prevention of DGF and other conditions related to acute kidney injury.
  • Successfully completed the single ascending dose (SAD) portion of the Company’s ongoing Phase 1 clinical trial in UNI-494. UNI-494 was well-tolerated up to 160 mg administered as a single dose and was chosen as the go-forward dose based on promising safety, tolerability, and pharmacokinetic data. In the multiple ascending dose (MAD) portion of the study, 80 mg is now being administered twice-a-day to trial participants.
  • Announced that two posters related to OLC will be presented at the National Kidney Foundation Spring Clinical Meeting taking place May 14-18, 2024, in Long Beach, California.
  • Announced that multiple presentations will be delivered on OLC and UNI-494 at the 61st European Renal Association (ERA) Congress taking place May 23-26, 2024, in Stockholm, Sweden.

Financial Results for the Year Ended December 31, 2023

Licensing Revenues: Licensing revenues for the year ended December 31, 2023 were $0.7 million compared to $1.0 million for the same period in 2022, due to an upfront payment for a licensing agreement entered into with Lotus International PTE Ltd in February 2023. We received an upfront payment of approximately $1.0 million associated with a licensing agreement entered into with Lee’s Pharmaceutical (HK) Limited in July 2022.

Research and Development (R&D) Expenses: R&D expenses for the full year were $12.9 million, compared to $12.4 million for the same period in 2022. The increase was primarily due to a $0.7 million increase in labor costs. Non-cash stock compensation increased $0.5 million. The increases were partially offset by a decrease in drug development costs of $0.7 million.

General and Administrative (G&A) Expenses: G&A expenses were $8.5 million, compared to $6.6 million for the same period in 2022. This increase was primarily due to an increase of $1.4 million in professional services costs. Labor costs increased $0.5 million, and other administrative costs increased $0.3 million. Non-cash stock compensation costs increased $0.3 million. The increases were partially offset by a decrease in insurance expense of $0.5 million.

Other Income (Expenses): Other income (expenses) increased $9.8 million due primarily to a $10.3 million change in fair value of our warrant liability. The Company earned interest income of $0.6 million on its cash balance during the year that was partially offset by a $0.1 million increase in interest expense.

Net Loss: Net loss attributable to common stockholders for the year ended December 31, 2023 was $31.4 million, or $1.28 per share of common stock, compared to a net loss of $18.1 million, or $1.20 per share of common stock, for the same period in 2022. This increase was attributable primarily to the $10.3 million change in fair value of our warrant liability.

Cash Position: As of December 31, 2023, cash and cash equivalents totaled $9.7 million. Subsequent to year end, in March 2024, Unicycive completed a private placement of preferred stock which generated $50 million in gross proceeds. The Company believes that with the inclusion of the net proceeds from this offering, it will have sufficient resources to fund planned operations into 2026.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn and YouTube.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

[email protected]
(650) 900-5470

SOURCE: Unicycive Therapeutics, Inc.

–Tables to Follow–

 
 
Unicycive Therapeutics, Inc.
       
Balance Sheets
(in thousands, except for share and per share amounts)
  As of As of
  December 31, December 31,
  2022 2023
      
Assets      
Current assets:      
Cash $455  $9,701 
Prepaid expenses and other current assets  2,189   3,698 
Total current assets  2,644   13,399 
Right of use asset, net  152   766 
Property, plant and equipment, net  22   26 
Total assets $2,818  $14,191 
       
Liabilities and stockholders’ deficit      
Current liabilities:      
Accounts payable $892  $839 
Accrued liabilities  2,237   3,234 
Warrant liability  –   13,134 
Operating lease liability – current  155   327 
Total current liabilities  3,284   17,534 
Operating lease liability – long term  –   466 
Total liabilities  3,284   18,000 
Commitments and contingencies      
Stockholders’ deficit:      
Series A-2 preferred stock, $0.001 par value per share – zero and 43,649 shares authorized at December 31, 2022 and December 31, 2023, respectively; zero and 43,649 shares outstanding at December 31, 2022 and December 31, 2023, respectively  –   – 
Preferred stock, $0.001 par value per share – 10,000,000 and 9,926,161 shares authorized at December 31, 2022 and December 31, 2023, respectively; no shares issued and outstanding at December 31, 2022 and 2023  –   – 
Common stock, $0.001 par value per share – 200,000,000 shares authorized at December 31, 2022 and 2023; 15,231,655 shares issued and outstanding at December 31, 2022, and 34,756,049 shares issued and outstanding at December 31, 2023  15   35 
Additional paid-in capital  33,516   60,697 
Accumulated deficit  (33,997)  (64,541)
Total stockholders’ deficit  (466)  (3,809)
Total liabilities and stockholders’ deficit $2,818  $14,191 
 
Unicycive Therapeutics, Inc.
       
Statements of Operations
(in thousands, except for share and per share amounts)
 
  Year Ended Year Ended
  December 31, December 31,
2022 2023
     
Licensing revenues: $951  $675 
Operating expenses:      
Research and development  12,436   12,902 
General and administrative  6,567   8,547 
Total operating expenses  19,003   21,449 
Loss from operations  (18,052)  (20,774)
Other income (expenses):      
Interest income  –   615 
Interest expense  (6)  (82)
Change in fair value of warrant liability  –   (10,303)
Total other income (expenses)  (6)  (9,770)
Net loss  (18,058)  (30,544)
Deemed dividend to Series A-1 preferred stockholders  –   (867)
Net loss attributable to common stockholders $(18,058) $(31,411)
Net loss per share attributable to common stockholders, basic and diluted $(1.20) $(1.28)
Weighted-average shares outstanding used in computing net loss per share, basic and diluted  15,057,049   24,539,309 

Source: Unicycive Therapeutics, Inc.

Released March 28, 2024

Release – GeoVax to Present Data on GEO-CM04S1, a Next Generation Covid-19 Vaccine, at the World Vaccine Congress

Posted on by [email protected]

Research News and Market Data on GOVX

 

Atlanta, GA, March 28, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that its Chief Scientific Officer, Mark Newman, PhD, will present data on GEO-CM04S1, the Company’s next-generation Covid-19 vaccine candidate, during the upcoming 24th Annual World Vaccine Congress taking place in Washington, DC on April 1-4, 2024.

Presentation Details:

Presenter:                  Mark Newman, PhD, Chief Scientific Officer

Date/Time:                Thursday, April 4, 2024, 12:00 pm ET

Location:                    Walter E. Washington Convention Center, Washington, DC

Presentation Title:    Vaccine Induction of Broadly-Specific Antibody and T Cell Responses to Combat SARS-CoV-2 Variation

Dr. Newman’s presentation will focus on results delineating the unique immune system driven mechanisms that contribute to the broad efficacy of GeoVax’s next-generation Covid-19 vaccine, GEO-CM04S1.

About GEO-CM04S1

GEO-CM04S1 is based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of Covid-19. Vaccines of this format should not require frequent and repeated modification or updating.

GEO-CM04S1 is currently being evaluated in three ongoing Phase 2 clinical trials:

  • As a primary vaccine in immunocompromised patients (with hematologic cancers receiving cell transplants or CAR-T therapy). ClinicalTrials.gov Identifier: NCT04977024. A recent presentation of unpublished data from the open-label portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses.
  • As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.
  • As a booster vaccine for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. This trial was fully enrolled in September 2023 and final results are expected in Fourth Quarter 2024, reflecting a 12-month tracking of study patients. gov Identifier: NCT04639466.

About GeoVax

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. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:                     Investor Relations Contact: Media Contact:
[email protected] [email protected]                     [email protected] 
678-384-7220 212-698-8699 202-779-0929

Release – PDS Biotech Announces Clinical Strategy Update and Reports Full Year 2023 Financial Results

Posted on by [email protected]

Research News and Market Data on PDSB

Unique mechanism of action of the combination of PDS01ADC and Versamune® results in 3-year survival of 75% and 75% overall response rate in advanced head and neck cancer trial

As a result, Company to focus late-stage clinical strategy on triple combination of PDS01ADC, PDS0101 (Versamune® HPV) and KEYTRUDA® in advanced head and neck cancer

Strong safety profile of IL-12 fused antibody drug conjugate (PDS01ADC) demonstrated to date with data generated in >300 cancer patients; Versamune® HPV tested in >110 HNSCC patients

Successful recent meeting with FDA provided clear guidance on trial design and regulatory pathway for pivotal randomized trial of triple combination in recurrent metastatic HPV-positive HNSCC

Company to host conference call and webcast today at 8:00 AM ET

PRINCETON, N.J., March 27, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced an update to its clinical development strategy and reported its financial results for the year ended December 31, 2023.

“We have obtained compelling data from several Phase 2 trials in the fourth quarter of 2023, including long-term survival data from the National Cancer Institute (NCI)-led triple combination trial of PDS01ADC in combination with Versamune® HPV (PDS0101) and an investigational immune checkpoint inhibitor (ICI), as well as our VERSATILE-002 study,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We now have a better understanding of how our drug platform technology works in advanced cancer, and we have therefore made the strategic, data-driven decision to add our novel, investigational IL-12 fused antibody drug conjugate, PDS01ADC, to the promising combination of Versamune® HPV and KEYTRUDA® to advance the triple combination as our top clinical development priority.”

“By initially addressing the rapidly growing unmet medical need in recurrent metastatic HPV+ head and neck squamous cell cancer (HNSCC), we strongly believe this approach may rapidly establish our proprietary combination of PDS01ADC and Versamune® HPV as a transformative oncology treatment. The data suggest that the triple combination may result in a significant improvement in overall survival rates for patients who currently lack an effective treatment option. It may also significantly increase the rates of durable tumor shrinkage or overall responses,” said Dr. Bedu-Addo. “We are grateful to the patients and physicians who participated in the clinical trials which have helped inform our understanding of how the drug therapies may be used most effectively to safely address advanced cancer, and our decision to prioritize the triple combination.”

With the recent long-term survival Phase 2 data from the NCI-led triple combination trial, together with favorable safety and extended survival results seen in both ICI naïve and resistant patients in our VERSATILE-002 trial, PDS Biotech has decided to prioritize the triple combination in place of the VERSATILE-003 trial. This decision enables PDS Biotech to focus its resources on the drug regimen it believes has the highest potential to benefit patients with HNSCC and to drive shareholder value.

“We have had several discussions with key opinion leaders in HNSCC regarding the use of the triple combination in HNSCC. A clear unmet need is seen in HPV+ HNSCC with few agents being studied in this population due to the difficulty in treating advanced HNSCC,” said Kirk V. Shepard, M.D., Chief Medical Officer of PDS Biotech. “These discussions with expert HNSCC oncologists have guided our decision to prioritize the triple combination in our efforts to address the growing incidence of advanced HPV+ HNSCC.”

“Despite good outcomes in many patients with HPV-related HNSCC, approximately 20% of patients will develop recurrent, incurable disease, often in young individuals in the prime of their lives. HPV-related HNSCC that progresses after standard first-line chemotherapy is a devastating, hard-to-treat cancer with no HPV-related treatment currently approved. The NCI clinical trial data show significant promise in the use of PDS01ADC in combination with Versamune® HPV,” said Katharine A. Price, M.D., Associate Professor of Oncology, Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center and Principal Investigator of PDS Biotech’s upcoming triple combination trial. “A controlled randomized clinical trial that builds upon the current data is warranted, and I am intrigued by the potential of this unique combination to treat HNSCC.”

Clinical Strategy Update

Triple Combination Clinical Trial (PDS01ADC, Versamune® HPV and KEYTRUDA®)

  • Company in discussions with the U.S. Food and Drug Administration (FDA) on the design of potentially pivotal clinical trial to treat HPV+ HNSCC, with the trial expected to start in 2024.
  • Previously announced data from Phase 2 NCI-led triple combination clinical trial for the treatment of recurrent/metastatic ICI naïve and ICI resistant HPV16-positive cancers including head and neck, anal, cervical, vaginal and vulvar cancers support rationale:
    • ICI naïve group: 75% of patients remain alive at 36 months. The median overall survival (OS) was not reached. Published results show a 36-month survival rate of approximately 20% with ICIs. An overall response rate (ORR) of 75% and complete response of 38% were seen in patients treated with the triple combination. Published ORR of <40% seen with immunotherapeutic agents.
    • ICI resistant group: 12-month OS rate of 72%, and 63% ORR in patients with optimal dose of PDS01ADC. Median OS approximately 20 months; published 12-month OS rate in HPV-positive ICI-resistant cancer is ~30%; published median OS in HPV-positive ICI-resistant cancer is 3.4 months.
    • Responses were seen in all HPV-positive tumor types.

Leadership Appointments

  • In January 2024, announced the appointment of Dr. Shepard as Chief Medical Officer.
  • In November 2023, announced the appointment of Lars Boesgaard as Chief Financial Officer.

Full Year 2023 Financial Results

Net loss for the year ended December 31, 2023, was approximately $42.9 million, or $1.39 per basic and diluted share, compared to a net loss of $40.9 million, or $1.43 per basic share and diluted share, for the year ended December 31, 2022. The higher net loss was primarily the result of increased operating loss and increased net interest expense.

Research and development expenses for the year ended December 31, 2023, decreased to $27.8 million, compared to $29.4 million for the year ended December 31, 2022. The decrease of $1.7 million was primarily attributable to the $10 million purchase of the rights to PDS01ADC in 2022, partially offset by an increase in clinical costs of $6.1 million and an increase in personnel costs of $2.1 million.

General and administrative expenses for the year ended December 31, 2023, increased to $15.3 million compared to $12.2 million for the year ended December 31, 2022. The $3.1 million increase was primarily attributable to an increase in personnel costs of $1.5 million and an increase in professional fees of $1.6 million.

Total operating expenses for the year ended December 31, 2023, were $43.0 million, an increase of approximately 3.3% compared to $41.7 million total operating expenses for the year ended December 31, 2022.

Net interest expense increased to $1.3 million for the year ended December 31, 2023, compared to $0.4 million for the year ended December 31, 2022. The change was due to higher interest expense related to the Company’s notes payable, partially offset by higher interest income on bank deposits.

During the fourth quarter of 2023, the Company raised approximately $10.5 million in net proceeds from its “at-the-market” sales agreement.

The Company’s cash balance as of December 31, 2023, was $56.6 million.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM ET today, March 27, 2024. Participants should dial 877-704-4453 (United States) or 201-389-0920 (International) and reference conference ID 13745320. To access the webcast, please use the following link. The event will be archived on the Investor Relations section of PDS Biotech’s website for six months.

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced head and neck squamous cell cancers (HNSCC). PDS Biotech’s lead program is a proprietary dual-acting combination of antibody drug conjugate (ADC) PDS01ADC and T-cell activator Versamune® HPV in regimen with a standard-of-care immune checkpoint inhibitor. Proof-of-concept long-term data have shown positive survival results and tumor shrinkage with this combination and indicate favorable tolerability.

With a novel investigational “inside-out” mechanism, the dual immunotherapy has shown compelling results with potential to successfully disrupt a tumor’s inside defenses, while also generating potent, targeted killer T-cells to attack the tumor from the outside. Robust data from more than 350 patients, as well as ongoing clinical trials across multiple tumor types and standard treatment regimens, have validated the platforms and point to potential broad utility.

Our Infectimune® based vaccines have 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. For more information, please visit www.pdsbiotech.com.

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 PDS01ADC, 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 PDS01ADC, 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; the Company’s ability to continue as a going concern; 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.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: [email protected]

Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: [email protected]

View full release here.

Big Pharma Goes Bio-Prospecting: Why Major Drug Makers Are Buying Innovative Biotech Startups

Posted on by [email protected]

The biotech sector has seen a flurry of acquisition activity in recent months, with large pharmaceutical companies opening their checkbooks to snap up promising small and micro-cap players. This deal-making frenzy underscores the value that nimble startups can bring to big pharma through their cutting-edge research and drug development pipelines.

For the pharmaceutical giants, acquiring innovative biotechs provides a vital influx of new drug candidates and therapies to revitalize stagnant pipelines and drive future revenue growth. Many large drug makers have struggled to internally develop enough new blockbuster treatments to replace aging cash cows going off-patent. Rather than go it alone in risky early-stage R&D, they are turning to biotech upstarts working at the frontiers of medicine.

These small biotech firms are proving to be fertile ground for novel drug discoveries. Despite their tiny team and budget, biotech startups can move nimbly to translate university research into therapeutic candidates. Their laser focus on narrow areas like orphan diseases, gene therapies, or targeted oncology treatments allows them to rapidly innovate in ways that large pharma bureaucracies cannot.

By acquiring these startups, big pharma gains a fast-track to promising new drugs and therapies that would take years and billions to develop internally. They can get first-mover advantage on groundbreaking new treatment modalities. Just as importantly, they acquire the entrepreneurial scientific talent behind the discoveries.

This acquisition appetite from pharma giants shows no signs of slowing. Just this month, AbbieVie acquired small biotech Landos Biopharma for $212 million to gain its promising autoimmune pipeline. AstraZeneca paid $2.4 billion for Fusion Pharmaceuticals and its next-gen oncology radioconjugates. The list goes on.

The drivers behind this deal surge were presciently spotted by Channelchek back in December 2023. Channelchek’s biotech research analysis predicted that the beaten-down biotech sector was poised for a major rebound, writing:

“The fresh upswing in biotech M&A follows a wave of dip buying from some the world’s largest asset managers in shares of industry leaders like Vertex Pharmaceuticals and Regeneron Pharmaceuticals. Warren Buffett’s Berkshire Hathaway has been particularly aggressive stepping in to purchase stakes in key biopharma bluechips.”

Channelchek’s forecast proved accurate, as biotech stocks have rallied and M&A activity has heated up in recent months. Big pharma’s shopping spree for innovative biotechs continues to gain momentum.

As Nico Pronk, Chief Executive Officer at Noble Capital Markets, stated: “Our platform aims to help amplify the stories of these cutting-edge biotech innovators to the investors and strategic partners seeking out emerging growth opportunities.” There is a funding gulf that still exists for startups looking to take their discoveries to the next level.

For investors and emerging biotechs seeking to capitalize on this next wave of consolidation, Noble Capital Markets is hosting its Emerging Growth Virtual Healthcare Equity Conference on April 17-18, 2024. This online investor forum will allow public healthcare, biotech and medical devices firms to present their company stories directly to institutional funds, family offices, and retail investor audiences. To register for this event showcasing the future disruptors of healthcare, visit the conference registration page here.

The big pharma acquisition binge shines a light on the value that small, innovative biotech players can bring to the healthcare ecosystem through their scientific discoveries. With deep-pocketed buyers on the prowl, the stage is set for the next generation of medical breakthroughs to be commercialized at scale.

Release – MAIA Biotechnology Announces $1.33 Million Private Placement

Posted on by [email protected]

Research News and Market Data on MAIA

March 26, 2024 8:01am EDT

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 578,643 shares of common stock at a purchase price of $2.295 per share, in a private placement to accredited investors. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $2.55 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six months following issuance and have a term of five years from the initial exercise date. The private placement is expected to close on or about March 28, 2024, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $1.33 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund research and development activities, such as to fund the first third of the pivotal accelerated approval Part C of the THIO-101 trial in non-small cell lung cancer (NSCLC).

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240326325996/en/

Investor Relations Contact
+1 (872) 270-3518
[email protected]

Source: MAIA Biotechnology, Inc.

Released March 26, 2024

ZyVersa Therapeutics, Inc. (ZVSA) – FY23 Reported With Reiteration of Milestones For Kidney and Inflammasome Trials

Posted on by [email protected]


Tuesday, March 26, 2024

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.

ZyVersa Reported FY2023. ZyVersa Reported a FY2023 loss of $106.2 million or $(108.97) per share, including write-downs of In-process Research and Development of $81.4 million and Goodwill of $11.9 million that were recorded with the reverse merger in December 2022. Excluding these items, the operating loss would have been $14.4 million. Cash on hand was $3.1 million on December 31, and does not include $2.7 million from warrant exercise reported during February 2024.

ZyVersa Has Made Progress Toward Starting VAR 200 Clinical Trials. ZyVersa announced the selection of a CRO and approval by an Institutional Review Board (IRB). These are steps required to start the Phase 2a clinical trial for VAR 200, its lead molecule for modulating cholesterol and lipid accumulation in the kidney that starts damage and declining function pathways. VAR 200 is expected to begin treating patients with diabetic kidney disease in 1H24.


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*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. 

Nuvation Bio Acquires AnHeart Therapeutics, Gains Promising Oncology Assets

Posted on by [email protected]

In a strategic move to strengthen its oncology pipeline, Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company focused on developing novel cancer therapies, has announced its acquisition of AnHeart Therapeutics Ltd. in an all-stock transaction. This acquisition promises to transform Nuvation Bio into a late-stage global oncology company, positioning it as a potential commercial organization by the end of 2025.

The deal, which is subject to approval by AnHeart’s shareholders and other customary closing conditions, is expected to close in the second quarter of 2024. Upon completion, the former shareholders of AnHeart will own approximately 33% of Nuvation Bio on a fully diluted basis, while the current stockholders of Nuvation Bio will retain a 67% stake.

The primary asset driving this acquisition is taletrectinib, AnHeart’s lead investigational therapy and a next-generation ROS1 inhibitor for the treatment of ROS1-positive non-small cell lung cancer (NSCLC). Taletrectinib has already received Breakthrough Therapy Designations from both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA).

Notably, taletrectinib is currently completing two pivotal Phase 2 studies, TRUST-I in China and TRUST-II, a global pivotal study, potentially positioning it as a best-in-class treatment option for patients with ROS1-positive NSCLC. The NMPA has also granted Priority Review Designation to New Drug Applications for taletrectinib, further underscoring its potential.

In addition to taletrectinib, the acquisition also brings safusidenib, a potentially best-in-class mutant IDH1 inhibitor, into Nuvation Bio’s pipeline. Safusidenib is currently being evaluated in a global Phase 2 study for the treatment of patients with grades 2 and 3 IDH1-mutant glioma.

“This transaction represents a significant milestone for our company and reflects Nuvation Bio’s continued commitment to developing therapies for patients with the most difficult-to-treat cancers,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “AnHeart’s lead asset, taletrectinib, which will become our lead asset as it completes two pivotal studies, is a differentiated, next-generation ROS1 inhibitor with a potentially best-in-class profile that may overcome the significant limitations of existing therapies.”

For Nuvation Bio, this all-stock acquisition preserves the company’s robust cash balance, enabling the development of both the newly acquired assets and its existing pipeline without the immediate need to raise additional capital. This financial strength positions Nuvation Bio to execute its development strategy effectively and advance its combined portfolio of differentiated oncology therapeutic candidates.

The acquisition also brings together the talented teams from both companies, with Nuvation Bio’s current management team, including Dr. Hung, remaining at the helm. Additionally, Min Cui, Ph.D., Founder and Managing Director of Decheng Capital, an investor in AnHeart, and Junyuan Jerry Wang, Ph.D., Co-Founder and Chief Executive Officer of AnHeart, will join Nuvation Bio’s board of directors.

As the demand for innovative cancer therapies continues to grow, Nuvation Bio’s acquisition of AnHeart Therapeutics represents a strategic move to bolster its oncology pipeline and position itself as a potential commercial organization in the near future. With taletrectinib and safusidenib as promising additions to its portfolio, Nuvation Bio is poised to make significant strides in addressing the unmet needs of patients with challenging forms of cancer.

Release – Eledon Pharmaceuticals Announces 12th Participant Enrolled in Phase 2 BESTOW Trial Evaluating Tegoprubart for the Prevention of Organ Rejection

Posted on by [email protected]

Research News and Market Data on ELDN

March 25, 2024

PDF Version

IRVINE, Calif., March 25, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the enrollment of the 12th participant on March 23, 2024, in the Company’s ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.

“We are pleased with the strong pace of enrollment in our Phase 2 BESTOW trial and believe it speaks to the underlying demand for a new immunosuppressive regimen for the tens of thousands of patients each year who undergo kidney transplantation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer.

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. Rejection occurs due to allorecognition, wherein the recipient’s immune system identifies the transplanted organ as foreign tissue, triggering an immune response against the transplanted organ. To reduce the risk of rejection, patients are treated with immunosuppressive therapies for life. Calcineurin inhibitors (“CNIs”) are a critical component of most immunosuppressive regimens to prevent acute and long-term organ transplant rejection. However, chronic exposure to CNIs (tacrolimus is the drug most commonly used) is associated with nephrotoxicity, hypertension, new onset diabetes due to pancreatic beta cell toxicity, as well as central nervous system side effects like tremor. Regarding kidney transplantation, the toxicity associated with CNIs causes 30-50% of kidney transplants to fail with 10-15 years of transplantation. 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

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). 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 the demand for a new and better immunosuppressive regimen for patients who undergo kidney transplantation, or statements about 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-Qs, 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. 

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

AbbVie’s Acquisition of Landos Biopharma Highlights Potential in Small-Cap Biotech

Posted on by [email protected]

In a strategic move that could have significant implications for the small-cap biotech sector, pharmaceutical giant AbbVie Inc. (NYSE: ABBV) announced its acquisition of Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company focused on developing novel oral therapeutics for autoimmune diseases. The deal, valued at approximately $212.5 million including contingent value rights, underscores the growing interest and potential in the small-cap biotech space, particularly in the field of inflammatory and autoimmune diseases.

Under the terms of the agreement, AbbVie will acquire Landos at $20.42 per share in cash upon closing, plus a contingent value right of up to $11.14 per share, subject to the achievement of a clinical development milestone. The acquisition is expected to close in the second quarter of 2024, subject to customary closing conditions, including approval by Landos’ stockholders.

The primary asset driving this deal is NX-13, Landos’ lead investigational asset and a first-in-class, oral NLRX1 agonist with a bimodal mechanism of action. NX-13 is currently in Phase 2 clinical trials for the treatment of ulcerative colitis (UC), a chronic inflammatory bowel disease affecting millions worldwide.

“With this acquisition, we aim to advance the clinical development of NX-13, a differentiated, first-in-class, oral asset with the potential to make a difference in the lives of people living with ulcerative colitis and Crohn’s disease,” said Roopal Thakkar, M.D., AbbVie’s senior vice president and chief medical officer, global therapeutics.

NX-13’s unique bimodal mechanism of action, which is both anti-inflammatory and facilitates epithelial repair, could provide a novel approach to treating UC and other inflammatory bowel diseases. If successful, it could address a significant unmet need in this therapeutic area.

The acquisition underscores AbbVie’s commitment to strengthening its portfolio in inflammatory and autoimmune diseases, which represent a substantial market opportunity. According to estimates, the global inflammatory bowel disease treatment market is projected to reach $8.6 billion by 2027, driven by factors such as increasing prevalence, rising healthcare expenditure, and a growing focus on developing targeted therapies.

For small-cap investors, this deal highlights the potential value and attractiveness of emerging biotech companies with promising pipeline candidates. As larger pharmaceutical companies seek to bolster their portfolios and drive innovation, strategic acquisitions of small-cap biotechs with compelling assets can provide attractive exit opportunities and significant returns for investors.

This acquisition also comes at an opportune time, as Noble Capital Markets’ upcoming virtual healthcare event on April 17-18 will showcase emerging growth companies in the healthcare, biotech, and medical device industries. Investors interested in exploring opportunities in the small-cap biotech space should mark their calendars for this event, which promises to provide valuable insights and potential investment prospects in this dynamic sector.

With the rising interest in novel therapies for inflammatory and autoimmune diseases, the AbbVie-Landos deal serves as a reminder of the potential value that can be unlocked in the small-cap biotech realm. As larger players seek to fortify their pipelines, the spotlight on promising small-cap innovators is likely to intensify, presenting exciting opportunities for investors in this space.

Eledon Pharmaceuticals (ELDN) – First Transplant Of A Pig Kidney Uses Tegoprubart To Prevent Immune Rejection

Posted on by [email protected]


Friday, March 22, 2024

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.

First Transplant Of A Genetically Modified Kidney To A Human. Eledon announced that tegoprubart, its drug in development to prevent organ transplant rejection, was used in the first transplant of an engineered pig kidney into a human patient. The kidney was genetically engineered by eGenesis, Inc, a company that has been collaborating with Eledon. Tegoprubart is currently in a Phase 2 clinical trial testing it against tacrolimus in prevention of kidney transplant rejection.

Eledon Has A Research Collaborated With eGenesis. The pig kidney was engineered by eGenesis, Inc, a company that formed a research collaboration with Eledon in January 2023. eGenesis has proprietary technology for engineering genetic changes to animal organs to make them compatible for transplantation into humans. As described in our Research Note on October 16, these genetic changes reduce the cross-species immunological barriers. The agreement allows eGenesis to use tegoprubart in its xenotransplantation research.


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Release – MAIA Biotechnology Welcomes Prominent Medical Oncology Scientist Dr. Saadettin Kilickap to Its Scientific Advisory Board

Posted on by [email protected]

Research News and Market Data on MAIA

March 21, 2024 3:00pm EDT

  • Acclaimed academic researcher has led 40+ multicenter phase 2 and phase 3 clinical studies

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced the appointment of Professor Saadettin Kilickap, M.D. to its Scientific Advisory Board (SAB).

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Professor Saadettin Kilickap, M.D., Scientific Advisor to MAIA Biotechnology (Photo: Business Wire)

Dr. Kilickap is a professor at the Istinye University Faculty of Medicine, Department of Medical Oncology, Liv Hospital in Turkey. His research focuses on medical oncology and cancer epidemiology, including solid tumors such as lung cancer, breast cancer, melanoma, and gastrointestinal system cancers, as well as targeted therapies and immunotherapy.

“Saadettin has served as principal or sub-investigator in more than 40 national and international multi-center phase 2 and phase 3 studies, many of which were related to lung cancer,” said Chief Executive Officer Vlad Vitoc, M.D. “He is a prominent voice on medical oncology and cancer epidemiology, with a special interest in quality of life for cancer patients. We are delighted to welcome him as Scientific Advisor as we begin to clear major clinical inflection points this year and progress with our groundbreaking cancer research.”

Prior to his current appointment, Dr. Kilickap was a professor at the Preventive Oncology Department of Hacettepe University Cancer Institute of Turkey. Earlier he worked in the Department of Hematology-Oncology at Regensburg University in Germany and was a faculty member at the Sivas Cumhuriyet University Faculty of Medicine, Department of Internal Medicine, in Turkey.

Dr. Kilickap graduated with honors from Gazi University Faculty of Medicine and went on to complete his internal medicine residency training at Hacettepe University Faculty of Medicine, both located in Ankara, Turkey. He completed his fellowship training at Hacettepe and became a medical oncology specialist in 2009. In the same year, he graduated from the Cancer Epidemiology Master’s Program at the Hacettepe University Oncology Institute, Department of Preventive Oncology.

Dr. Kilickap has authored more than 240 scientific articles published in international peer-reviewed journals, and delivered more than 50 poster presentations at international congresses.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

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Source: MAIA Biotechnology, Inc.

Released March 21, 2024

AstraZeneca Makes $2.4 Billion Bet on Next-Gen Cancer Radioconjugates

Posted on by [email protected]

In a bold move to fortify its oncology pipeline, pharmaceutical giant AstraZeneca (NASDAQ: AZN) has agreed to acquire clinical-stage biotech Fusion Pharmaceuticals (NASDAQ: FUSN) for up to $2.4 billion. The deal gives AstraZeneca full access to Fusion’s pioneering radioconjugate (RC) therapies and expertise as it aims to transform cancer treatment and unseat traditional chemotherapy and radiation regimens.

Fusion specializes in developing a promising new class of precision oncology drugs called RCs, which dispense powerful, targeted radiation directly to cancer cells via targeting molecules like antibodies. By delivering potent radioisotope payloads to tumors in this manner, RCs may improve upon external beam radiation’s limitations and indiscriminately toxic effects.

Under the agreed terms, AstraZeneca will pay $21 per share in cash upfront to acquire all outstanding Fusion shares, valuing the biotech at approximately $2 billion. This headline price represents a staggering 97% premium over Fusion’s closing price prior to deal announcement. AstraZeneca has also committed up to $3 per share in additional contingent value rights tied to a future regulatory milestone, which could push the total deal value to $2.4 billion if achieved.

For AstraZeneca, the acquisition paves the way for a major expansion into promising RC therapeutics, which could revolutionize how cancers are treated in the future. The crown jewel of the deal is FPI-2265, Fusion’s lead RC candidate that uses the alpha particle-emitting isotope actinium-225 to target PSMA proteins in metastatic castration-resistant prostate cancer. FPI-2265 is already in Phase 2 clinical trials with early data expected in 2024.

Beyond this advanced asset, AstraZeneca gains control of Fusion’s broader pipeline of RC programs and candidates across multiple solid tumor types. Just as importantly, the transaction provides AstraZeneca with Fusion’s specialized R&D capabilities, manufacturing infrastructure, and actinium-225 supply chain specifically tailored for developing these next-wave radiotherapeutics.

This strategic acquisition doubles down on AstraZeneca’s burgeoning radio-isotope therapy initiatives. The pharma giant already has a collaboration with Fusion exploring lung cancer applications using one of its RC molecules. By bringing Fusion’s RC therapy capabilities fully in-house, AstraZeneca can now swiftly integrate and scale up this cutting-edge treatment modality across its industry-leading oncology portfolio.

For Fusion investors, the buyout represents a lucrative exit at a substantial premium, especially compared to the company’s $300 million market cap prior to deal reports. While always bittersweet to see a promising biotech get absorbed, Fusion’s technology and team are now set to be fueled by abundant AstraZeneca resources in pursuing RC breakthroughs.

The transaction, expected to close in Q2 2024 pending customary approvals, foreshadows a future where RCs could potentially supplant chemotherapy and radiotherapy as more precise, less toxic foundational cancer regimens. While still an emerging field, AstraZeneca’s bold multi-billion dollar investment signals its confidence in harnessing RCs’ unique advantages over traditional oncology treatments.

As AstraZeneca executes an ambitious pivot toward next-generation RC therapies, biotech and pharma investors would be wise to monitor this rapidly evolving space. The acquisition of Fusion continues to position the pharma titan at the vanguard of replacing archaic cancer protocols with targeted radioconjugate precision medicines.