Altamira Therapeutics Provides Business Update, Reports FY 2022 Financial Results
- Management will host an investor conference call today,
May 16th , at8 a.m. Eastern - Company is advancing OligoPhore™ / SemaPhore™ platform for extrahepatic RNA delivery and efficient endosomal release; expects first research collaborations with biopharmaceutical companies in 2023
- Filed IND submission with FDA for AM-125 in acute vestibular syndrome
- ‘Showcase' RNA development programs AM-401 and AM-411 progressing in KRAS-driven cancers and rheumatoid arthritis, targeting INDs in 2024
- Divestiture or partnering of legacy assets remains a key strategic focus
- Top-line data from full NASAR trial with Bentrio in seasonal allergic rhinitis expected in the second quarter
"We continue to make good progress on our journey to become a leading provider of innovative RNA delivery technology," stated
"At the same time, we are fast approaching important clinical and regulatory milestones with our legacy programs in OTC consumer health and in inner ear therapeutics,"
"These milestones will be important elements in our strategy to divest or partner the legacy programs as the second step in our transformation to become a leading pure-play technology platform company in RNA delivery technology. Through this process, we expect to unlock the intrinsic value of our legacy businesses. While it has taken longer than initially expected, we look forward to major progress and its conclusion this year."
RNA Delivery Technology Update
Altamira has been making good progress with its strategic pivot to RNA delivery technology around its OligoPhore / SemaPhore platforms. The technology is based on a patented peptide for delivery of RNA in nanoparticles to extrahepatic tissues and efficient endosomal release inside target cells. It has been successfully tested in numerous animal disease models with both siRNA (short interfering RNA) and mRNA (messenger RNA). Recently, additional promising data were reported:
- At the 2023
Osteoarthritis Research Society International (OARSI) World Congress held in March inDenver , aWashington University research group presented data from a mouse model of meniscal injury. Systemic delivery of DNA-methyltransferase 3 beta (DNMT3B) mRNA with SemaPhore nanoparticles significantly reduced bone sclerosis, cartilage degeneration, and synovitis (inflammation of the connective tissue lining the inside of a joint capsule) compared to controls. In addition, functional studies showed significantly decreased pain sensitivity and improved weight bearing. - In a
March 2023 article preprint, anotherWashington University research group presented data from a mouse model of sarcoma and metastatic breast cancer. Systemic delivery of ZBTB46 (zinc finger and BTB domain containing 46) mRNA with SemaPhore nanoparticles promoted anti-tumor components in the tumor microenvironment and resulted in the restriction of tumor growth. When the nanoparticle treatment was combined with an anti-PD1 immune checkpoint inhibitor, significant synergistic effects in the control of tumor growth were observed, generating long-term complete remission of tumor mass in many of the treated animals.
Since 2022, Altamira has stepped up its efforts to present and promote its OligoPhore / SemaPhore platforms at international conferences and its business development activities targeted at potential partners in the biopharmaceutical industry. In general, consistent with its capital efficient RNA business model, the Company plans to focus on providing its nanoparticle technology to licensees rather than develop and commercialize its own drug products.
Concurrently, the Company continued the development work on its two ‘showcase' development programs with the OligoPhore platform for siRNA delivery - AM-401 for the treatment of KRAS-driven tumors and AM-411 for the treatment of rheumatoid arthritis (NF-kB). In
Bentrio® Nasal Spray
The clinical development program for Bentrio, the Company's novel drug-free nasal spray for protection against harmful airborne particles such as allergens, is nearly complete. In
The data read-out from the NASAR trial in
In contrast, the outcomes from the COVAMID trial with Bentrio in 160 patients suffering from acute COVID-19 which were reported in
As part of its strategic pivot to a pure-play RNA delivery technology company, Altamira initiated discussions last year with several well-established OTC consumer health companies for partnering on Bentrio for
Inner Ear Therapeutics
In
Based on the positive outcomes from TRAVERS, the Company filed an IND application this past week with the FDA. The IND, if granted, would allow conducting clinical trials with AM-125 in the US as well. The submission includes the protocol for a Phase 2 trial in the treatment of posterior canal benign paroxysmal positional vertigo (BPPV), which is the most common type of vertigo and characterized by repeated episodes of vertigo produced by changes in the head position relative to gravity. A recently published meta-analysis shows statistically significant improvement in dizziness handicap for BPPV patients when treated with oral betahistine over the standard of care procedure alone. By avoiding the fast metabolism after oral intake, intranasal delivery of AM-125 achieves higher bioavailability of betahistine (5-to-29 times higher).
In the context of its strategic pivot to RNA delivery technology, Altamira intends to divest or partner the AM-125 program for further development and commercialization that includes the implementation of a Phase 2 clinical study. To this end, the Company has initiated discussions with a number of potential partners and expects to intensify such efforts following now that the IND has been submitted.
Full Year 2022 Financial Results
- Revenues for the full year of 2022 were
CHF 0.3 million compared toCHF 0.1 million for the full year of 2021. The 2022 revenues exclude a non-refundable upfront license fee ofCHF 0.9 million from Nuance Pharma related to the marketing and distribution of Bentrio in Mainland China,Hong Kong ,Macau andSouth Korea which was deferred for revenue recognition.[1] - Total operating loss for the full year of 2022 was
CHF 26.1 million , orCHF 13.7 million before a one-time non-cash write-off (impairment) of capitalized development expenditures for the AM-125 project based on impairment testing under IFRS, compared withCHF 16.8 million for the full year of 2021. - Research and development expenses for the full year of 2022 were
CHF 19.7 million , orCHF 7.3 million before the aforementioned one-time non-cash write-off (impairment) of capitalized development expenditures for the AM-125 project, compared withCHF 8.4 million for the full year of 2021. - General and administrative expenses for the full year of 2022 were
CHF 3.6 million compared withCHF 4.9 million for the full year of 2021. - Net loss for the full year of 2022 was
CHF 26.5 million , orCHF 14.1 million before the aforementioned one-time non-cash write-off (impairment) of capitalized development expenditures for the AM-125 project, compared withCHF 17.1 million for the full year of 2021. - Cash and cash equivalents on
December 31, 2022 totaledCHF 15 thousand compared withCHF 1.0 million atDecember 31, 2021 .
[1]Revenue recognition for the upfront payment is deferred until transfer of production to Nuance, which will occur 4 years after Nuance obtaining the first national registration of Bentrio® in the territory or upon Nuance's cumulative orders for Bentrio® reaching a contractually defined minimum quantity of Bentrio® from the Company, whichever comes later. The upfront payment was incorrectly recorded as revenue in the Unaudited Condensed Consolidated Interim Financial Statements of the Company as of
In
During the first four months of 2023, Altamira raised
FY2022 Investor Teleconference Details
Altamira management will hold an investor call today,
- Date:
Tuesday, May 16, 2023 - Time:
8:00 a.m. Eastern Time (5:00 a.m. Pacific Time ) - Webcast URL: https://www.webcaster4.com/Webcast/Page/2797/48448
- Toll-free dial-in number: 888-506-0062
- International dial-in number: 973-528-0011
- Participant Access Code: 250106
Conference Call Replay
A replay of the call will be available after the live event and archived for two weeks until
- Toll-free dial-in number: 877-481-4010
- International dial-in number: 919-882-2331
- Replay Passcode: 48448
Consolidated Statement of Profit or Loss and Other Comprehensive Income/(Loss)
For the Years Ended
(in CHF)
|
2022 | 20211) | ||||||
Revenue
|
305,616 | 63,882 | ||||||
Cost of Sales
|
(1,443,855 | ) | (2,240,554 | ) | ||||
Gross profit
|
(1,138,239 | ) | (2,176,672 | ) | ||||
Other operating income
|
709,449 | 214,217 | ||||||
Research and development
|
(19,677,756 | ) | (8,360,821 | ) | ||||
Sales and marketing
|
(2,381,384 | ) | (1,498,218 | ) | ||||
General and administrative
|
(3,644,549 | ) | (4,946,576 | ) | ||||
Operating loss
|
(26,132,479 | ) | (16,768,070 | ) | ||||
Interest income
|
969 | 3,219 | ||||||
Interest expense
|
(911,869 | ) | (189,695 | ) | ||||
Foreign currency exchange gain/(loss), net
|
54,645 | 328,641 | ||||||
Revaluation gain/(loss) from derivative financial instruments
|
451,131 | (410,918 | ) | |||||
Transaction costs
|
(1,137 | ) | - | |||||
Loss before tax
|
(26,538,740 | ) | (17,036,823 | ) | ||||
Income tax gain/(loss)
|
10,329 | (21,620 | ) | |||||
Net loss attributable to owners of the Company
|
(26,528,411 | ) | (17,058,443 | ) | ||||
Other comprehensive income/(loss):
|
||||||||
Items that will never be reclassified to profit or loss
|
||||||||
Remeasurements of defined benefit liability, net of taxes of
|
441,277 | 264,984 | ||||||
Items that are or may be reclassified to profit or loss
|
||||||||
Foreign currency translation differences, net of taxes of
|
61,046 | 772 | ||||||
Other comprehensive income/(loss), net of taxes of
|
502,323 | 265,756 | ||||||
Total comprehensive loss attributable to owners of the Company
|
(26,026,088 | ) | (16,792,687 | ) | ||||
Basic and diluted loss per share
|
(29.13 | ) | (25.76 | ) |
1) Revised 2) Weighted average number of shares outstanding: 2022: 910,723; 2021: 662,314.
Consolidated Statement of Financial Position
As of
(in CHF)
|
2022 |
20211) |
||||||
ASSETS
|
||||||||
Non-current assets
|
||||||||
Property and equipment
|
1 | 1 | ||||||
Right-of-use assets
|
445,827 | 564,714 | ||||||
Intangible assets
|
3,893,681 | 14,314,877 | ||||||
Other non-current financial assets
|
194,263 | 199,105 | ||||||
Total non-current assets
|
4,533,772 | 15,078,697 | ||||||
Current assets
|
||||||||
Inventories
|
11,644 | 839,221 | ||||||
Trade receivables
|
6,525 | 21,746 | ||||||
Other receivables
|
755,987 | 917,833 | ||||||
Prepayments
|
709,266 | 996,910 | ||||||
Derivative financial instruments
|
270,176 | 0 | ||||||
Cash and cash equivalents
|
15,395 | 984,191 | ||||||
Total current assets
|
1,768,993 | 3,759,901 | ||||||
Total assets
|
6,302,765 | 18,838,598 | ||||||
EQUITY AND LIABILITIES
|
||||||||
Equity
|
||||||||
Share capital
|
236,011 | 149,643 | ||||||
Share premium
|
192,622,406 | 188,511,476 | ||||||
Foreign currency translation reserve
|
258,044 | 62,069 | ||||||
Accumulated deficit
|
(201,431,272 | ) | (175,686,937 | ) | ||||
Total shareholders' (deficit)/equity attributable to owners of the Company
|
(8,314,811 | ) | 12,704,528 | |||||
Non-current liabilities
|
||||||||
Derivative financial instruments
|
0 | 1,233 | ||||||
Non-current lease liabilities
|
343,629 | 461,485 | ||||||
Employee benefit liability
|
336,206 | 668,319 | ||||||
Deferred income
|
932,200 | 0 | ||||||
Deferred tax liabilities
|
125,870 | 142,484 | ||||||
Total non-current liabilities
|
1,737,905 | 1,273,521 | ||||||
Current liabilities
|
||||||||
Loan
|
5,869,797 | 0 | ||||||
Current lease liabilities
|
117,856 | 114,251 | ||||||
Trade and other payables
|
4,914,404 | 3,697,723 | ||||||
Accrued expenses
|
1,977,614 | 1,048,575 | ||||||
Total current liabilities
|
12,879,671 | 4,860,549 | ||||||
Total liabilities
|
14,617,576 | 6,134,070 | ||||||
Total equity and liabilities
|
6,302,765 | 18,838,598 |
1) Revised
About
Forward-Looking Statements
This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or
CONTACT:
Hear@altamiratherapeutics.com
800-460-0183
SOURCE:
accesswire.com
https://www.accesswire.com/755179/Altamira-Therapeutics-Provides-Business-Update-Reports-FY-2022-Financial-Results