Category: Health

PDS Biotechnology (PDSB) – FY2023 Results Included Changes In Development Strategy

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, March 28, 2024

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

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.

FY2023 Financial Results Included Updated Clinical Trial Strategy. PDS Reported a FY2023 loss of $44.3 million or $(1.43) per share, with cash on December 31, 2023, of $42.9 million. Importantly, the company changed its clinical development plan for PDS1010 and PDS01ADC. The Phase 3 VERSAMUNE-003 will not begin as we expected in 1H24. A Phase 3 trial testing the Triple-Therapy combination will be conducted instead. 

Decision Was Driven By Data From Two Trials. PDS has completed two Phase 2 trials, its VERSATILE-002 trial and the Triple Combination Study conducted by the National Cancer Institute (NCI). VERSATILE-002 trial tested the combination of PDS0101 with Keytruda (pembrolizumab, a PD-1 checkpoint inhibitor), while the Triple Therapy Trial tested PDS0101, a checkpoint inhibitor, and PDS01ADC, a proprietary IL-12-derived molecule.

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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. 

Boundless Bio $100M IPO to Advance Novel Cancer Therapies

Posted on by slightbourne@noblecapitalmarkets.com

Boundless Bio, a biotech company pioneering a new approach to treating cancer, made its public debut on the Nasdaq stock exchange today in a $100 million initial public offering. The Cambridge, Massachusetts company is the latest biotech firm to go public in 2024 after last year’s IPO drought, pricing its shares at $16 each under the ticker symbol “BOLD.”

The $100 million capital raise will provide a major boost to Boundless Bio’s pipeline of experimental cancer therapies that target extrachromosomal DNA (ecDNA), double-stranded DNA molecules that exist outside of chromosomes and can contain amplified oncogenes driving tumor growth.

“EcDNA represents an exciting new frontier in cancer biology and a promising opportunity for therapeutic intervention,” said Zachary Hartman, CEO of Boundless Bio. “With this successful IPO, we are now well-capitalized to advance our novel ecDNA-targeted candidates through clinical trials and hopefully translate this cutting-edge science into meaningful treatments for patients.”

Leading the way for Boundless is BBI-355, the company’s most advanced program that inhibits checkpoint kinase 1, an enzyme involved in ecDNA replication and transcription. BBI-355 is currently being evaluated in the Phase 1/2 POTENTIATE study, with initial data from up to 90 patients expected in the second half of this year.

Not far behind is BBI-825, an oral ribonucleotide reductase inhibitor that targets a different mechanism related to ecDNA biology. This second clinical candidate entered Phase 1/2 testing just last month in the STARMAP trial, with early results anticipated in late 2025.

In addition to developing therapeutics, a portion of the $100 million IPO proceeds will fund Boundless Bio’s efforts to create a diagnostic test called ECHO to detect ecDNA levels in cancer patients’ tumors. The company believes this could enable more precise treatment by identifying patients most likely to respond to ecDNA-targeted therapies.

The successful Nasdaq listing bucks the trend of a biotech IPO market that was essentially frozen in 2023 amid volatile market conditions. But investor sentiment appears to have rebounded in 2024, with Boundless Bio becoming the seventh biotech to go public so far this year.

“This is an incredibly promising time for Boundless Bio and for companies working on novel modalities that could reshape cancer treatment,” said Tricia Lorida, a biotech analyst at SVB Securities. “While ecDNA therapies are still at an early stage, there is certainly excitement around targeting these unique DNA drivers of tumor growth and genomic instability.”

Boundless Bio’s IPO was led by Goldman Sachs, Guggenheim Securities, Piper Sandler, and Leerink Partners as joint book-running managers. The company granted underwriters a 30-day option to purchase up to an additional 937,500 shares at the IPO price, which could raise the total deal proceeds to $115 million if exercised in full.

With the $100 million-plus capital infusion, Boundless Bio is well-positioned to advance its pioneering work in the emerging field of ecDNA biology as the company aims to unlock new therapeutic options for cancer patients. The successful IPO marks an ambitious first step, but much will ride on the clinical data readouts expected over the next couple of years.

The successful $100 million IPO by Boundless Bio could pave the way for more biotech companies to tap the public markets in 2024 as investor appetite appears to be returning. After a dismal 2023 that saw very few biotechs go public, the new year has brought a flurry of IPO activity, with Boundless Bio becoming the seventh biotech to debut on the Nasdaq. Other drug developers waiting in the wings may seize the opportunity to join the IPO queue if market conditions remain favorable. An opening of the IPO window would provide a crucial capital infusion for biotech firms to continue advancing their R&D programs amid a challenging funding environment. While clinical data will ultimately determine the fates of these newly public companies, a reinvigorated IPO market bodes well for biotech innovation lingering in the pipeline.

Release – Schwazze Announces Fourth Quarter And Full Year 2023 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SHWZ

March 27, 2024

PDF Version

 FY 2023 Revenue of $172.4 Million; Income from Operations of $3.3 Million; Adjusted EBITDA of $53.4 Million or 31% of Revenue

 Generated $12.2 Million of Operating Cash Flow in FY 2023

DENVER, March 27, 2024 /CNW/ – Medicine Man Technologies, Inc., operating as Schwazze, (OTCQX: SHWZ) (Cboe: SHWZ) (“Schwazze” or the “Company”), today announced financial and operational results for the fourth quarter and full year ended December 31, 2023.

“This past year, the Schwazze team delivered solid top-line growth in two highly competitive markets with 31% adjusted EBITDA margins and improved operating cash flow,” said Forrest Hoffmaster, Interim CEO of Schwazze. “We continued to sharpen our retail strategy while expanding our store footprint by more than 50% to 63 dispensaries across our two markets. Although the Colorado and New Mexico markets were pressured in 2023, we have built a solid foundation with best-in-class service for our patients and customers. Internally, we are also relentlessly focused on maximizing the operating efficiencies of our manufacturing and cultivation facilities to drive higher yields, improved flower quality, and greater output.”

“With strong demand and over 680 recreational retail stores at year-end, the competitive landscape in Colorado is fierce, underscoring the importance of our investments in and attention to elevating the customer experience. We significantly outpaced the market in Q4 on a sequential and year-over-year basis and expect to bolster our growth through improvements in customer acquisition, retention, and loyalty, as well as in the overall retail experience. Additionally, we are beginning to see wholesale pricing stabilize, which we anticipate will continue based on plant counts and ongoing retail pricing pressure.”

“In New Mexico, the proliferation of new licenses has led to increased competition and aggressive pricing strategies from certain players. Cannabis sales in the state were up 18% across a store base that was over 50% higher year-over-year in Q4, leading to lower average revenue per store. While we are beginning to see a slow-down in net new store openings, we anticipate a challenging market ahead. We remain focused on cost optimization and asset utilization while implementing a balanced pricing and promotional strategy to drive traffic into our stores, where we believe we excel in delivering an elevated retail experience. We are committed to fulfilling our promise of being the retailer of choice in New Mexico.”

“Looking ahead, we are optimistic about the regulatory momentum in the industry at large. In the meantime, we will continue to elevate the customer experience, improve our loyalty program, increase our cost efficiencies, and enhance our retail assets. Our team has a demonstrated track record of executing in competitive markets like Colorado and New Mexico where we remain one of the largest operators. We look forward to driving growth and profitability across each of our markets in 2024.”

Fourth Quarter 2023 Financial Summary

$ in Thousands USDQ4 2023Q3 2023Q4 2022
Total Revenue$43,325$46,747$40,147
Gross Profit$7,034$21,438$21,719
Adjusted Gross Profit[1]$20,180$21,438$21,719
Operating Expenses$23,276$12,514$24,224
Income (Loss) from Operations$(16,242)$8,924$(2,505)
Adjusted EBITDA[2]$10,953$14,119$13,285
Operating Cash Flow$3,452$6,946$6,260

Full Year 2023 Financial Summary

$ in Thousands USDFY 2023FY 2022
Total Revenue$172,448$159,379
Gross Profit$76,024$80,289
Adjusted Gross Profit1$89,170$86,830
Operating Expenses$72,735$67,434
Income from Operations$3,289$12,855
Adjusted EBITDA2$53,412$52,010
Operating Cash Flow$12,201$6,694
___________________________
1  Adjusted Gross Profit is a non-GAAP measure as defined by the SEC and represents gross profit excluding non-cash inventory adjustments. The Company uses Adjusted Gross Profit as it believes it better explains the results of its core business. See “ADJUSTED GROSS PROFIT RECONCILIATION (NON-GAAP)” section herein for an explanation and reconciliations of non-GAAP measure used throughout this release.
2  Adjusted EBITDA is a non-GAAP measure as defined by the SEC, and represents earnings before interest, taxes, depreciation, and amortization, adjusted for other income, non-cash share-based compensation, one-time transaction related expenses, or other non-operating costs. The Company uses Adjusted EBITDA as it believes it better explains the results of its core business. See “ADJUSTED EBITDA RECONCILIATION (NON-GAAP)” section herein for an explanation and reconciliations of non-GAAP measure used throughout this release.

Full Year 2023 Operational Highlights

  • Expanded the Company’s retail footprint by more than 50% in New Mexico and Colorado to 63 dispensaries.
  • Completed the acquisition of Everest Apothecary, adding 14 dispensaries, one cultivation facility, and one manufacturing plant to the Company’s New Mexico operations.
  • Acquired Standing Akimbo, the largest medical cannabis dispensary in Colorado, and opened the Company’s first medical dispensary in Colorado Springs under the Standing Akimbo banner.
  • Acquired two Colorado retail dispensaries in Fort Collins and Garden City from Smokey’s.
  • Unveiled an enhanced, custom ecommerce platform in New Mexico under the R. Greenleaf banner.
  • Increased wholesale penetration in Colorado and New Mexico by over 3x year-over-year to more than 27% total door penetration in both states.
  • Grew Lowell Farms pre-roll sales by over 250% in Colorado where it is now the #1 pre-roll in the state. In addition, Lowell is in six of the largest Colorado accounts and will be available for wholesale in New Mexico starting April 1st, 2024.
  • Grew sales with Wana, our fan-favorite gummies brand, by 48% in New Mexico where it is now in 130 doors with eight of the top ten accounts in the state.

Fourth Quarter 2023 Financial Results

Total revenue in the fourth quarter of 2023 increased 8% to $43.3 million compared to $40.1 million for the same quarter last year. The increase was primarily due to growth from new stores compared to the prior year period and increased wholesale revenue, partially offset by pricing pressure from the proliferation of new licenses in New Mexico.

Gross profit for the fourth quarter of 2023 was $7.0 million or 16.2% of total revenue, compared to $21.7 million or 54.1% of total revenue for the same quarter last year. The decrease in gross margin was primarily driven by one-time, non-cash inventory adjustments of approximately $13.1 million comprised of $3.1 million of product consolidation, obsolescence, and shrinkage expenses, $4.3 million of net realizable value adjustments, and $5.8 million of fair value adjustments on acquired inventory in New Mexico in 2023. Adjusted gross profit, which excludes non-cash inventory adjustments, for the fourth quarter of 2023 was $20.2 million or 46.6% of revenue.

Operating expenses for the fourth quarter of 2023 were $23.3 million compared to $24.2 million for the same quarter last year. The decrease was primarily due to a lower impairment charge in the fourth quarter of 2023. This was partially offset by an increase in four-wall SG&A expenses associated with the 22 additional stores in Colorado and New Mexico that are still ramping, as well as greater salaries and stock-based compensation.

Loss from operations for the fourth quarter of 2023 was $16.2 million compared to $2.5 million in the same quarter last year. The decrease was driven by the aforementioned lower gross profit, primarily related to the non-cash inventory adjustment. Net loss was $33.9 million for the fourth quarter of 2023 compared to $27.3 million for the same quarter last year.

Adjusted EBITDA for the fourth quarter of 2023 was $11.0 million or 25.3% of revenue, compared to $13.3 million or 33.1% of revenue for the same quarter last year. The decrease in Adjusted EBITDA margin was primarily driven by higher operating expenses associated with the 22 additional stores that are still ramping.

As of December 31, 2023, cash and cash equivalents were $19.2 million compared to $38.9 million on December 31, 2022. Total debt as of December 31, 2023, was $156.8 million compared to $127.8 million on December 31, 2022.

Conference Call

The Company will conduct a conference call today, March 27, 2024, at 5:00 p.m. Eastern time to discuss its results for the fourth quarter and full year ended December 31, 2023.

Schwazze management will host the conference call, followed by a question-and-answer period. Interested parties may submit questions to the Company prior to the call by emailing ir@schwazze.com.

Date: Wednesday, March 27, 2024
Time: 5:00 p.m. Eastern time
Toll-free dial-in: (888) 664-6383
International dial-in: (416) 764-8650
Conference ID: 38840334
Webcast: SHWZ Q4 & FY 2023 Earnings Call

The conference call will also be broadcast live and available for replay on the investor relations section of the Company’s website at https://ir.schwazze.com.

Toll-free replay number: (888) 390-0541
International replay number: (416) 764-8677
Replay ID: 840334

If you have any difficulty registering or connecting with the conference call, please contact Elevate IR at (720) 330-2829.

About Schwazze

Schwazze (OTCQX: SHWZ) (Cboe: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to explore taking its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale.

Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth. To learn more about Schwazze, visit https://schwazze.com/.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include financial outlooks; any projections of net sales, earnings, or other financial items; any statements of the strategies, plans and objectives of our management team for future operations; expectations in connection with the Company’s previously announced business plans; any statements regarding future economic conditions or performance; and statements regarding the intent, belief or current expectations of our management team. Such statements may be preceded by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intends,” “plans,” “strategy,” “prospects,” “anticipate,” “believe,” “approximately,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” or the negative of these terms or other words of similar meaning in connection with a discussion of future events or future operating or financial performance, although the absence of these words does not necessarily mean that a statement is not forward-looking. We have based our forward-looking statements on management’s current expectations and assumptions about future events and trends affecting our business and industry. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. Therefore, forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) regulatory limitations on our products and services and the uncertainty in the application of federal, state, and local laws to our business, and any changes in such laws; (ii) our ability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (iii) our ability to identify, consummate, and integrate anticipated acquisitions; (iv) general industry and economic conditions; (v) our ability to access adequate capital upon terms and conditions that are acceptable to us; (vi) our ability to pay interest and principal on outstanding debt when due; (vii) volatility in credit and market conditions; (viii) the loss of one or more key executives or other key employees; and (ix) other risks and uncertainties related to the cannabis market and our business strategy. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

Investor Relations Contact
Sean Mansouri, CFA or Aaron D’Souza
Elevate IR
(720) 330-2829
ir@schwazze.com

MEDICINE MAN TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME AND (LOSS)
For the Periods Ended December 31, 2023 and 2022
Expressed in U.S. Dollars

For the Three Months EndedFor the Twelve Months Ended
December 31,December 31,
2023202220232022
(Unaudited)(Unaudited)(Audited)(Audited)
Operating Revenues
Retail$39,592,779$36,868,429$155,463,816$141,254,893
Wholesale3,730,7493,158,67016,765,42517,819,938
Other1,287120,188218,545304,388
Total Revenue43,324,81540,147,287172,447,786159,379,219
Total Cost of Goods & Services36,291,05918,428,52896,424,15079,090,461
Gross Profit7,033,75621,718,75976,023,63680,288,758
Operating Expenses
Selling, General and Administrative Expenses10,848,0298,922,62739,916,51829,036,962
Professional Services1,115,4571,112,9753,558,5016,722,554
Loss on Impairment1,810,8908,011,4051,801,7408,011,405
Salaries6,561,8005,292,99623,883,35420,990,290
Stock Based Compensation2,952,669883,8903,574,8312,672,713
Total Operating Expenses23,288,84524,223,89372,734,94467,433,924
Income from Operations(16,255,089)(2,505,134)3,288,69212,854,834
Other Income (Expense)
Interest Expense, net(8,112,391)(6,827,557)(32,069,082)(30,139,645)
Unrealized Gain (Loss) on Derivative Liabilities1,384,228(9,690,200)15,870,23318,414,760
Other Loss68,4003,73668,40024,136
Loss on Business Disposition(1,968,807)(4,684,366)(1,968,807)(4,684,366)
Unrealized Gain (Loss) on Investments–3,0831,816(39,270)
Total Other Income (Expense)(8,628,570)(21,195,304)(18,097,441)(16,424,385)
Pre-Tax Net Income (Loss)(24,883,659)(23,700,438)(14,808,749)(3,569,551)
Provision for Income Taxes4,494,0493,638,69519,740,59514,898,064
Net Income (Loss)$(29,377,708)$(27,339,133)$(34,549,344)$(18,467,615)
Less: Accumulated Preferred Stock Dividends for the Period(1,541,341)(2,508,677)(8,154,993)(7,802,809)
Net Income (Loss) Attributable to Common Stockholders$(30,919,049)$(29,847,810)$(42,704,337)$(26,270,424)
Earnings (Loss) per Share Attributable to Common Stockholders
Basic Earnings (Loss) per Share$(0.43)$(0.57)$(0.66)$(0.49)
Diluted Earnings (Loss) per Share$(0.43)$(0.57)$(0.66)$(0.49)
Weighted Average Number of Shares Outstanding – Basic71,680,20053,637,00364,535,24553,637,003
Weighted Average Number of Shares Outstanding – Diluted71,680,20053,637,00364,535,24553,637,003
Comprehensive Income (Loss)$(29,377,708)$(27,339,133)$(34,549,344)$(18,467,615)

MEDICINE MAN TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Periods Ended December 31, 2023 and 2022
Expressed in U.S. Dollars

For the Twelve Months Ended
December 31,
20232022
(Audited)(Audited)
Cash Flows from Operating Activities:
Net Income (Loss) for the Period$(34,549,344)$(18,467,615)
Adjustments to Reconcile Net Income (Loss) to Cash for Operating Activities
Depreciation & Amortization20,933,54110,660,172
Non-Cash Interest Expense4,024,6044,118,391
Impairment of Goodwill1,801,7408,011,405
Non-Cash Lease Expense7,648,5313,910,679
Deferred Taxes(2,090,967)502,070
Loss on Disposition of Business Units1,968,8074,684,369
Change in Derivative Liabilities(15,870,233)(18,414,760)
Amortization of Debt Issuance Costs1,686,0491,686,048
Amortization of Debt Discount8,523,4937,484,613
(Gain) Loss on Investments, net(1,816)39,270
Stock Based Compensation3,590,473812,073
Changes in Operating Assets & Liabilities (net of Acquired Amounts):
Accounts Receivable927,259(105,185)
Inventory4,571,069789,399
Prepaid Expenses & Other Current Assets1,579,349(2,770,179)
Other Assets263,419(248,682)
Change in Operating Lease Liabilities(7,498,128)(13,113,041)
Accounts Payable & Other Liabilities(3,241,850)11,845,245
Income Taxes Payable17,934,9675,270,074
Net Cash Provided by (Used in) Operating Activities12,200,9636,694,346
Cash Flows from Investing Activities:
Collection of Notes Receivable11,944–
Cash Consideration for Acquisition of Business, net of Cash Acquired(15,834,378)(58,981,226)
Purchase of Fixed Assets(7,865,654)(14,007,892)
Purchase of Intangible Assets(2,750,000)–
Investment in Private Entity–(2,000,000)
Net Cash Provided by (Used in) Investing Activities(26,438,088)(74,989,118)
Cash Flows from Financing Activities:
Payment on Notes Payable(5,354,218)(134,498)
Proceeds from Issuance of Common Stock–978,308
Payment for Statutory Withholdings on RSU(108,978)–
Net Cash Provided by (Used in) Financing Activities(5,463,196)843,810
Net (Decrease) in Cash & Cash Equivalents(19,700,321)(67,450,962)
Cash & Cash Equivalents at Beginning of Period38,949,253106,400,216
Cash & Cash Equivalents at End of Period$19,248,932$38,949,253
Supplemental Disclosure of Cash Flow Information:
Cash Paid for Interest$17,896,954$15,243,990
Cash Paid for Income Taxes5,000,00012,340,000

MEDICINE MAN TECHNOLOGIES, INC.
ADJUSTED EBITDA RECONCILIATION (NON-GAAP)
For the Periods Ended December 31, 2023 and 2022
Expressed in U.S. Dollars

For the Three Months EndedFor the Twelve Months Ended
December 31,December 31,
2023202220232022
Net Income (Loss)$(29,364,680)$(27,339,133)$(34,549,344)$(18,467,615)
Interest Expense, net8,112,3916,827,55732,069,08230,139,645
Provision for Income Taxes4,494,0493,638,69519,740,59514,898,064
Other (Income) Expense, net of Interest Expense516,18014,367,747(13,971,641)(13,715,260)
Depreciation & Amortization3,162,4253,701,12818,970,96012,524,677
Earnings Before Interest, Taxes, Depreciation and
Amortization (EBITDA) (non-GAAP)$(13,079,635)$1,195,994$22,259,652$25,379,511
Non-Cash Stock Compensation1,597,157883,8902,219,3192,672,713
Deal Related Expenses2,196,7331,914,8205,528,0486,822,111
Capital Raise Related Expenses1,779(257,271)38,559533,958
Inventory Adjustment to Fair Market Value for
Purchase Accounting5,792,488–5,792,4886,541,651
One-Time Inventory Impairment7,353,972–7,353,972–
One-Time Goodwill Impairment1,801,7408,011,4051,801,7408,011,405
Severance111,752263,374537,584334,910
Retention Program Expenses––505,655–
Employee Relocation Expenses5,065(3,750)70,10715,360
Pre-Operating & Dark Carry Expenses2,663,8241,027,7382,663,8241,027,738
One-Time Legal Settlements1,204,058440,0001,204,058440,000
Other Non-Recurring Items1,304,501(191,674)3,436,773230,858
Adjusted EBITDA (non-GAAP)$10,953,434$13,284,526$53,411,779$52,010,215
Revenue43,324,81540,147,287172,447,786159,379,219
Adjusted EBITDA Percent25.3 %33.1 %31.0 %32.6 %

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SOURCE Schwazze

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

Posted on by aweinsoff@channelchek.com

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: mmoyer@lifesciadvisors.com

Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: gmangiaracina@6degreespr.com

View full release here.

Release – MAIA Biotechnology Announces $1.33 Million Private Placement

Posted on by aweinsoff@channelchek.com

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
ir@maiabiotech.com

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 cpereira@noblefcm.com


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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Nuvation Bio Acquires AnHeart Therapeutics, Gains Promising Oncology Assets

Posted on by slightbourne@noblecapitalmarkets.com

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 aweinsoff@channelchek.com

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
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

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

Posted on by slightbourne@noblecapitalmarkets.com

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.

Release – ZyVersa Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Mar 25, 2024

Key Highlights:

  • Cholesterol Efflux MediatorTM VAR 200 on target to begin Phase 2a clinical trial in patients with diabetic kidney disease H1-2024.
  • Inflammasome ASC Inhibitor IC 100 preclinical program nearing completion, with planned Investigational New Drug (IND) submission Q4-2024, and Phase 1 clinical trial initiation shortly thereafter.
  • Inflammasome ASC Inhibitor IC 100 preclinical research funded by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) nearing completion, with potential for a second MJFF grant for further research.
  • Scientific collaboration to assess Inflammasome ASC Inhibitor IC 100 as a potential treatment for atherosclerosis expected to conclude H1-2024.
  • Scientific collaboration to assess Inflammasome ASC Inhibitor IC 100 as a potential treatment for obesity and metabolic syndrome expected to begin Q2-2024.

WESTON, Fla., March 25, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, reports financial results for full year ending December 31, 2023, and provides business update.

“Throughout 2023 and early 2024, ZyVersa achieved considerable progress in advancing development of our two lead candidates. A Phase 2a clinical trial with Cholesterol Efflux MediatorTM VAR 200 is on target to be initiated in the first half of this year in patients with diabetic kidney disease; preclinical studies for indication expansion are underway for Parkinson’s disease, atherosclerosis, and obesity with Inflammasome ASC Inhibitor IC 100; and IND submission for IC 100 is expected by end of the year,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “We view 2024 as a potentially transformative year for the company based on the value-building milestones that we expect to achieve over the next 12 to 15 months. I look forward to working with my leadership team and fellow Board members to execute a business and clinical strategy that has potential to position ZyVersa as a leading, innovative company developing transformative drugs for underserved patients with renal and inflammasome-mediated inflammatory diseases.” 

BUSINESS Update

CHOLESTEROL EFFLUX MEDIATORTM VAR 200 FOR RENAL DISEASE

  • Phase 2a clinical trial in patients with diabetic kidney disease is on target to begin in the first half of 2024.
  • CRO, George Clinical was engaged in December 2023 to initiate and manage the trial.
  • An IND amendment to study diabetic kidney disease was filed on February 16, 2024.
  • A central Institutional Review Board (IRB) approved the clinical trial protocol for trial initiation.

INFLAMMASOME ASC INHIBITOR IC 100 FOR INFLAMMATORY DISEASES

  • Inflammasome ASC Inhibitor IC 100’s preclinical program is nearing completion, with a planned IND submission in Q4-2024, followed by initiation of a Phase 1 clinical trial shortly thereafter.
  • Preclinical research funded by MJFF and conducted by researchers at University of Miami Miller School of Medicine to determine the potential of Inflammasome ASC Inhibitor IC 100 to block the damaging neuroinflammation that induces neural degeneration in Parkinson’s disease is nearing completion.
  • Research update and key findings were provided to MJFF project team on March 8, 2024.
  • Based on the findings, the MJFF project team suggested that the team apply for a second grant to further the research in an established animal model.
  • A scientific collaboration was initiated with an undisclosed partner to assess the potential of Inflammasome ASC Inhibitor IC 100 as a treatment for atherosclerosis in a well-established animal model.
  • Study is expected to conclude in H1-2024.
  • A scientific collaboration with inflammasome and neurology experts at University of Miami Miller School of Medicine to assess the potential of Inflammasome ASC Inhibitor IC 100 as a treatment for obesity and metabolic syndrome is expected to begin in Q2-2024.

YEAR END 2023 FINANCIAL RESULTS

Net losses were $98.3 million for the year ended December 31, 2023 (the “2023 Period”), an increase of $84.2 million compared to a net loss of $14.1 million for the “2022 Period,” which is comprised of the financial results of the company containing our operations prior to our business combination from January 1, 2022 through December 12, 2022, and our financial results after the business combination, from December 13, 2022 through December 31, 2022. A deferred tax benefit of $9.5 million for the 2023 Period, compared to $0.7 million tax benefit during the 2022 Period, resulted from the impairment of the in-process research and development.

Pre-tax losses were $107.8 million for the 2023 Period, an increase of $92.9 million compared to a pre-tax loss of $14.9 million for the 2022 Period. The higher net loss reported for the 2023 Period is primarily due to the impairment of in-process research and development and impairment of goodwill of $81.4 million and $11.9 million, respectively, compared to none for the 2022 Period. The impairment is a result of the decline in stock value and the resulting market capitalization of ZyVersa during the 2023 Period.

Based on its current operating plan, ZyVersa expects its cash of $3.1 million as of December 31, 2023 will be sufficient to fund its operating expenses and capital expenditure requirements on a month-to-month basis. ZyVersa will need additional financing to support its continuing operations. ZyVersa will seek to fund its operations through public or private equity or debt financings or other sources, which may include government grants and collaborations with third parties. 

Research and development expenses for the 2023 Period were $3.2 million, a decrease of $2.6 million or 44.8% from $5.8 million for the 2022 Period. The decrease in research and development expenses was primarily due to spending for materials supplies for manufacturing in 2022 that were not required in 2023 as manufacturing was completed in 2022. 

General and administrative expenses for the 2023 Period were $11.2 million, an increase of $3.2 million or 39.7% from $8.0 million for the 2022 Period. The increase is primarily attributed to increased costs for legal and professional fees of $2.7 million, investor and public relations fees of $1.2 million, and increased director and officer insurance of $1.3 million, all due to increased costs associated with being a public company. These were offset by reduced business combination transaction costs of $2.2 million.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and peripheral inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, 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. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc. (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate, Media, IR Contact

Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

ZYVERSA THERAPEUTICS, INC. 
CONSOLIDATED BALANCE SHEETS 
  
    Successor 
    December 31, 
     2023   2022  
        
Assets       
        
Current Assets:     
 Cash $3,137,674  $5,902,199  
 Prepaid expenses and other current assets 215,459   225,347  
 Vendor deposits  –   235,000  
  Total Current Assets 3,353,133   6,362,546  
Equipment, net  6,933   17,333  
In-process research and development 18,647,903   100,086,329  
Goodwill  –   11,895,033  
Security deposit  98,476   46,659  
Operating lease right-of-use asset 7,839   98,371  
        
  Total Assets$22,114,284  $118,506,271  
        
Liabilities, Temporary Equity and Stockholders’ Equity    
        
Current Liabilities:     
 Accounts payable $8,431,583  $6,025,645  
 Accrued expenses and other current liabilities 1,754,533   2,053,559  
 Operating lease liability 8,656   108,756  
  Total Current Liabilities 10,194,772   8,187,960  
Deferred tax liability  844,914   10,323,983  
  Total Liabilities 11,039,686   18,511,943  
        
Commitments and contingencies    
        
 Redeemable common stock, subject to possible redemption,    
 0 and 1,880 shares outstanding as of December 31, 2023 and    
 2022, respectively –   331,331  
Stockholders’ Equity:     
 Preferred stock, $0.0001 par value, 1,000,000 shares authorized:    
 Series A preferred stock, 8,635 shares designated, 50 and 8,635 shares issued    
 and outstanding as of December 31, 2023 and 2022, respectively –   1  
 Series B preferred stock, 5,062 shares designated, 5,062 shares issued    
 and outstanding as of December 31, 2023 and 2022, respectively 1   1  
 Common stock, $0.0001 par value, 250,000,000 shares authorized;    
 4,052,119 and 257,604 shares issued at December 31, 2023 and 2022,    
 respectively, and 4,052,057 and 257,604 shares outstanding as of    
 December 31, 2023 and 2022, respectively 405   26  
 Additional paid-in-capital 114,300,484   104,584,147  
 Accumulated deficit (103,219,124)  (4,921,178) 
 Treasury stock, at cost, 62 and 0 shares at December 31, 2023    
 and 2022, respectively (7,168)  –  
  Total Stockholders’ Equity 11,074,598   99,662,997  
        
  Total Liabilities, Temporary Equity and Stockholders’ Equity$22,114,284  $118,506,271  
        
ZYVERSA THERAPEUTICS, INC. 
CONSOLIDATED STATEMENTS OF OPERATIONS 
  
          
   Successor  Predecessor 
   For the For the period  For the period 
   Year Ended December 13 through  January 1 through 
   December 31, December 31,  December 12, 
    2023   2022    2022  
          
          
          
Operating Expenses:       
 Research and development$3,207,573  $399,894   $5,407,859  
 General and administrative 11,213,201   420,174    7,605,205  
 Impairment of in-process research and development 81,438,426   –    –  
 Impairment of goodwill 11,895,033   –    –  
  Total Operating Expenses 107,754,233   820,068    13,013,064  
          
  Loss From Operations (107,754,233)  (820,068)   (13,013,064) 
          
Other (Income) Expense:       
 Interest (income) expense (457)  –    427,542  
 Change in fair value of derivative liabilities –   –    607,001  
          
  Pre-Tax Net Loss (107,753,776)  (820,068)   (14,047,607) 
  Income tax benefit 9,455,830   745,050    –  
  Net Loss (98,297,946)  (75,018)   (14,047,607) 
  Deemed dividend to preferred stockholders (7,948,209)  –    (10,015,837) 
  Net Loss Attributable to Common Stockholders$(106,246,155) $(75,018)  $(24,063,444) 
          
          
  Net Loss Per Share       
  – Basic and Diluted$(108.97) $(0.29)  $(0.99) 
          
  Weighted Average Number of       
  Common Shares Outstanding       
  – Basic and Diluted 975,035   257,604    24,194,270  

Release – Tonix Pharmaceuticals Receives Rare Pediatric Disease Designation from the FDA for TNX-2900 for the Treatment of Prader-Willi Syndrome

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

March 25, 2024 8:00am EDT

TNX-2900 is a proprietary magnesium-potentiated formulation of intranasal oxytocin, a naturally occurring hormone that reduces appetite and eating

Prader Willi syndrome is the most common genetic cause of life-threatening childhood obesity

CHATHAM, N.J., March 25, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to TNX-2900* (intranasal potentiated oxytocin), a proprietary magnesium (Mg2+)-potentiated formulation of intranasal oxytocin, to treat Prader-Willi syndrome (PWS) in children and adolescents. TNX-2900 was previously granted Orphan Drug designation by the FDA in 2022 for the treatment of PWS and the investigational new drug (IND) application was cleared by the FDA in 2023. The Company may be eligible to receive a transferable Priority Review Voucher if TNX-2900 for PWS is approved for marketing. Recently, vouchers have sold for approximately $100 million.

“The Rare Pediatric Disease Designation is an important regulatory milestone in the development of TNX-2900. With PWS being the most common genetic cause of life-threatening childhood obesity, we are excited that the FDA has recognized this significant unmet need in children and adolescents, particularly for PWS hyperphagia, which currently has no approved treatments1,2,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “As PWS is a genetic disorder associated with abnormalities of the oxytocin system, Tonix believes TNX-2900’s unique formulation has the potential to improve intranasal oxytocin’s therapeutic action by addressing limitations in efficacy observed at high-dose intranasal oxytocin that is not Mg2+-potentiated3,4.”

The FDA defines a rare pediatric disease as a serious or life-threating disease that primarily affects individuals aged from birth to 18 years and affects under 200,000 people in the United States.

About FDA’s Rare Pediatric Disease Priority Voucher Program

The FDA’s Rare Pediatric Disease Priority Voucher Program is intended to encourage the development of new drugs to treat certain rare pediatric diseases. Under the FDA’s Rare Pediatric Disease Designation and Voucher Program, if TNX-2900 is approved for marketing, Tonix may qualify for a priority review voucher that can be redeemed to receive priority review of a subsequent marketing application for a different product. Priority review vouchers may also be sold or transferred to another sponsor. The new sponsor can redeem the voucher to receive priority review for a different product, which reduces the review time of NDAs from 10 months to six months. There is no limit on the number of times a priority review voucher can be transferred. A 2020 U.S. Government Accounting Office analysis5 of the voucher program found that in the ten years since launch of the program in 2009, the price of buying priority review vouchers ranged from $67 million to $350 million. More recently, priority review vouchers were acquired by Novo Nordisk for $110 million in June of 2022, and by Novartis for $100 million from Marinus in July of 2022.6   Bluebird Bio sold vouchers for $102 million, $95 million and $103 million in November 2022, January 2023, and October 2023, respectively.7-9 In June of 2023, Novartis bought a priority review voucher from Pharming for $21 million, a price that had been negotiated as part of a purchase agreement when Pharming acquired the asset from Novartis.5

About Prader-Willi Syndrome (PWS)

PWS is recognized as the most common genetic cause of life-threatening childhood obesity and affects males and females with equal frequency and all races and ethnicities. PWS results from the absence of expression of a group of genes on the paternally acquired chromosome 15. The hallmarks of PWS are lack of suckling in newborns and, in children and adolescents, severe hyperphagia – an overriding physiological drive to eat, leading to severe obesity and other complications associated with significant mortality. A systematic review of the morbidity and mortality as a consequence of hyperphagia in PWS found that the average age of death in PWS was 22.1 years.10 There is no approved medication to treat poor feeding in newborns or hyperphagia in children and adolescents with PWS. Given the serious or life-threatening manifestations of these conditions, there is a critical need for effective treatments to decrease morbidity and mortality, improve quality of life, and increase life expectancy in people with PWS. Oxytocin has potent effects in correcting behavioral characteristics of the Magel2 knock-out mouse model for PWS and autism.11-13 Six clinical trials have investigated intranasal oxytocin as a treatment in pediatric patients with PWS. Four studies showed evidence for improvement in PWS-related behaviors/symptoms14-17; three clinical studies reported evidence for improvement in hyperphagia14,15,17; and one clinical study showed an improvement in sucking in infants16.

About TNX-2900 and Tonix’s Potentiated Oxytocin Platform

TNX-2900 is based on Tonix’s patented intranasal Mg2+-potentiated oxytocin formulation intended for use by children and adolescents. This formulation is believed to enhance the potency of oxytocin as well as increase specificity for oxytocin receptors relative to vasopressin receptors, potentially reducing unwanted side effects from activating vasopressin receptors. Tonix is also developing a different intranasal formulation, designated TNX-1900 for adolescent obesity, binge eating disorder, bone health in autism, and social anxiety disorder. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. Oxytocin is believed to be more than 600 million years old and is present in vertebrates including mammals, birds, reptiles, amphibians, and fish.18 It was initially approved by the U.S. Food and Drug Administration as Pitocin®**, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor and control postpartum bleeding or hemorrhage. An intranasal formulation of oxytocin is marketed in some European countries to assist in breast milk production as Syntocinon®*** (oxytocin nasal 40 units/ml).

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication. Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia.

**Pitocin® is a trademark of Par Pharmaceutical, Inc.

***Syntocinon® is a trademark of BGP Products Operations GmbH

Citations

  1. Meyerowitz JG, et al. Nat Struct Mol Biol. 2022. 29(3):274-281.
  2. Meziane H, et al. Biol Psychiatry. 2015. 78(2):85-94.
  3. Correa-da-Silva F, et al. J Neuroendocrinol. 2021. 33(7):e12994.
  4. Bharadwaj VN, et al. Pharmaceutics. 2022. 14(5):1105.
  5. U.S. Government Accounting Office, Jan 31, 2020. “Drug Development: FDA’s Priority Review Voucher Programs”. GAO-20-251. https://www.gao.gov/products/gao-20-251.
  6. Waldron, J. Fierce Biotech. June 1, 2023. “Novartis buys priority review voucher from Pharming for discount price of $21 M.” www.fiercebiotech.com/biotech/novartis-buys-priority-review-voucher-pharming-discount-price-21m
  7. BlueBird bio Press Release. Nov. 30, 2022 “bluebird bio Sells Priority Review Voucher for $102 Million”. https://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-sells-priority-review-voucher-102-million
  8. Kansteiner, F. Fierce Pharma. Jan 6, 2023 “Bluebird scores $95M nest egg after selling second FDA priority review voucher to BMS”. http://www.fiercepharma.com/pharma/bluebird-scores-another-nest-egg-after-selling-second-fda-review-voucher-bms-95m 
  9. Business Wire. October 30, 2023. “bluebird bio Enters into Advance Agreement to Sell Priority Review Voucher, if Granted, for $103 Million.” http://finance.yahoo.com/news/bluebird-bio-enters-advance-agreement-120000768.html
  10. Bellis SA, et al. Eur J Med Genet. 2022. 65(1):104379.
  11. Bertoni A, et al. Mol Psychiatry. 2021. 26(12):7582-7595.
  12. Schaller F, et al. Hum Mol Genet. 2010. 19:4895-4905.
  13. Meziane H, et al. Biol Psychiatry. 2015. 78: 85-94.
  14. Kuppens RJ, et al. Clin Endocrinol. 2016. 85:979-987.
  15. Miller JL et al. Am J Med Genet A. 2017. 173: 1243-1250.
  16. Tauber M, et al. Pediatrics. 2017. 139(2):e20162976.
  17. Damen L, et al. Clin Endocrinol. 2020. 94:774-785.
  18. Gruber CW. Exp Physiol. 2014. 99(1):55-61. doi: 10.1113/expphysiol.2013.072561.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

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 by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of 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, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
443-213-0495

Source: Tonix Pharmaceuticals Holding Corp.

Released March 25, 2024

Release – Unicycive Therapeutics to Be Featured In Multiple Presentations At The Upcoming European Renal Association Congress

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

March 25, 2024 7:03am EDT Download as PDF

LOS ALTOS, Calif., March 25, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced that multiple presentations will be delivered on the Company’s product candidates, oxylanthanum carbonate (OLC) and UNI-494, at the 61st European Renal Association (ERA) Congress taking place May 23-26, 2024, in Stockholm, Sweden.

Shalabh Gupta, MD, Chief Executive Officer of Unicycive, commented, “The ERA Congress is one of the most prominent nephrology meetings of the year, and we are excited to deliver presentations on both OLC and UNI-494. In addition to presenting preclinical data supporting both of our programs, we will also be reporting on our two clinical trials in progress. We look forward to participating in this important event.”

Oxylanthanum Carbonate (OLC)

Title:Enhanced Urinary Phosphorous Reduction: Comparative Study of Oxylanthanum Carbonate and Tenapanor in Rats
Lead Author:Satya Medicherla, Ph.D., Vice President, Preclinical Pharmacology, Unicycive
Type:Focused Oral Presentation
Dates/Times:May 25, 2024 from 12:10 p.m. – 12:15 p.m. CEST
  
Title:Oxylanthanum Carbonate for Hyperphosphatemia in End Stage Kidney Disease (ESKD): Tolerability Trial in Progress
Lead Author:Pablo E. Pergola, M.D., Ph.D., Renal Associates, P.A.
Type:ePoster
Date/Time:Available throughout the conference
  

UNI-494

Title:Oral Administration of UNI-494 Ameliorates Acute Kidney Injury in a Rat Model of Delayed Graft Function
Lead Author: Satya Medicherla, Ph.D., Vice President, Preclinical Pharmacology, Unicycive
Type:Focused Oral Presentation
Dates/Times:May 25, 2024 from 12:00 p.m. – 12:05 p.m. CEST
  
Title:UNI-494 Phase I Tolerability and Pharmacokinetics: Trial in Progress
Lead Author:Guru Reddy, Ph.D., Vice President of Preclinical R&D, Unicycive
Type:Focused Oral Presentation
Dates/Times:May 25, 2024 from 12:45 p.m. – 12:50 p.m. CEST
  

About Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.5 billion in 2023, with the United States accounting for more than $1 billion of that total. Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. As part of the clinical development program, two clinical studies were conducted in over 100 healthy volunteers. The first study was a dose-ranging Phase I study to determine safety and tolerability. The second study was a randomized, open-label, two-way crossover bioequivalence study to establish pharmacodynamic bioequivalence between OLC and Fosrenol. Based on the topline results of the bioequivalence study, pharmacodynamic (PD) bioequivalence of OLC to Fosrenol was established.

Fosrenol® is a registered trademark of Shire International Licensing BV.
1Reason Research, LLC 2022 survey. Results here.

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.

Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

About UNI-494

UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. Unicycive is currently conducting a Phase 1 dose-ranging safety study in healthy volunteers in the United Kingdom that is expected to complete in 2H of 2024. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide. UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.

About Delayed Graft Function

Delayed Graft Function (DGF) refers to the acute kidney injury (AKI) that occurs in the first week after kidney transplantation, which necessitates dialysis intervention. As the name indicates, DGF can result in sub-optimal or impaired graft function and is one of the most common and serious complications of kidney transplantation. Poor kidney function in the first week of graft life is detrimental to the longevity of the allograft. DGF is also associated with higher rates of tissue rejection and decreased patient survival. Currently, there are no FDA approved drugs for the treatment of DGF.

Ischemia/reperfusion injury (IRI) is known to be a major causative factor for the AKI that results in DGF during kidney transplantation. Ischemic preconditioning, that works by activating KATP channels in mitochondria, is a natural endogenous mechanism which protects cells from IRI in the heart, kidney, liver, and other organs. UNI-494 is a pharmacological approach that emulates and enhances this natural phenomenon of ischemic preconditioning.

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 late preclinical development for the treatment of 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, 2022, 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:

ir@unicycive.com 
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc

Released March 25, 2024

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

Posted on by cpereira@noblefcm.com


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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