ONCOTELIC PROVIDES YE 2021 FINANCIAL RESULTS COMPARED TO YE 2020, PRODUCT DEVELOPMET INITIATIVES AND CORPORATE UPDATE
Oncotelic Therapeutics, Inc. (OTCQB:OTLC) announced its financial results for FY 2021, revealing a net loss of approximately $10.5 million, compared to a $10 million loss in FY 2020. The company reported no service revenue in FY 2021, a decline from $1.7 million in FY 2020. Research and development expenses decreased to $3.7 million, while general and administrative costs increased to $5.5 million. The company formed a joint venture with Dragon Overseas, expected to reduce future expenses, and anticipates significant operational changes in FY 2022, focusing on new drug developments and potential uplisting to a national stock exchange.
- Joint venture with Dragon Overseas to reduce operational costs and enhance drug development.
- Anticipated significant reduction in cash requirements due to JV, allowing focus on AL-101 and OT-101 development.
- AL-101 is positioned as a fast-to-market candidate for Parkinson's and erectile dysfunction, with previous clinical trials showing promise.
- Net loss increased by approximately $545,484 compared to FY 2020.
- No service revenue reported for FY 2021, a significant decline from $1.7 million in FY 2020.
- Working capital deficit increased from $10.6 million in FY 2020 to $14.8 million in FY 2021.
AGOURA HILLS, Calif., April 18, 2022 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (“Oncotelic”, “We” or the “Company”) (OTCQB:OTLC) today announced financial results for the full year ended December 31, 2021 (“FY 2021”) as compared to the full year ended December 31, 2020 (“FY 2020”), an update on its product and therapeutic development initiatives and other corporate updates. The financial results were based on the 2021 Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 15, 2022.
FY 2021 compared to FY 2020 Financial Results Overview
ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE YEAR ENDED DECEMBER 31
2021 | 2020 | Variance | ||||||||||
Revenue | - | |||||||||||
Service revenue | $ | - | $ | 1,740,855 | $ | (1,740,855 | ) | |||||
Total revenue | - | 1,740,855 | (1,740,855 | ) | ||||||||
Operating expense: | ||||||||||||
Research and development | $ | 3,658,617 | $ | 4,302,447 | $ | (643,830 | ) | |||||
General and administrative | 5,467,266 | 5,023,142 | 444,124 | |||||||||
Total operating expense | 9,125,883 | 9,325,589 | (199,706 | ) | ||||||||
Loss from operations | (9,125,883 | ) | (7,584,734 | ) | (1,541,149 | ) | ||||||
Interest expense, net | (2,002,813 | ) | (1,998,321 | ) | (4,492 | ) | ||||||
PPP loan forgiveness | 346,761 | - | 346,761 | |||||||||
Change in the value of derivatives | 292,149 | (45,051 | ) | 337,200 | ||||||||
Loss on debt conversion | (27,504 | ) | (343,700 | ) | 316,196 | |||||||
Net loss | $ | (10,517,290 | ) | $ | (9,971,806 | ) | $ | (545,484 | ) |
Net Loss
We recorded a net loss of approximately
Revenue
We recorded services revenue of
Research and Development Expense
Research and Development (“R&D”) expense decreased by approximately
General and Administrative Expense
General and administrative (“G&A”) expense increased by approximately
Change in value of derivatives
During FY 2021, we recorded a gain of
Interest Expense
We recorded interest expense, including amortization of debt costs, of
Liquidity, Financial Condition and Capital Resources ($s in ‘000’s)
December 31, 2021 | December 31, 2020 | |||||||
Cash, including restricted cash | $ | 588 | $ | 494 | ||||
Working capital | (14,828 | ) | (10,567 | ) | ||||
Stockholders’ Equity | 8,158 | 12,481 |
As the end of FY 2021, the Company had approximately
Cash Flows ($s in ‘000s)
Year ended December 31, | ||||||||
2021 | 2020 | |||||||
Net cash used in operating activities | $ | (4,288 | ) | $ | (2,812 | ) | ||
Net cash provided by financing activities | 4,383 | 3,224 | ||||||
Increase in cash | $ | 95 | $ | 412 |
Operating Activities
Net cash used in operating activities was approximately
Financing Activities
For FY 2021, net cash provided by financing activities was approximately
Highlights for Q4 2021 and thereafter:
In October 2021, the Company entered into an unsecured convertible note purchase agreement with GMP, pursuant to which the Company issued a convertible promissory note in the aggregate principal amount of
In September 2021, the Company entered into an exclusive License Agreement (the “Agreement”) with Autotelic, Inc. (“Autotelic”), pursuant to which Autotelic granted the Company the exclusive right and license to certain Autotelic Patents and Know-How and a right of first refusal to acquire at least a majority of the outstanding capital stock of Autotelic prior to Autotelic entering into any transaction as defined in the agreement. In exchange for the rights granted to Oncotelic, Autotelic will be entitled to earn the milestone payments of up to
In November and December 2021, the Company entered into securities purchase agreement with five institutional investors, whereby the Company issued five convertible notes in the aggregate principal amount of
“FY 2021 was a challenging, but an exciting year for all of us at Oncotelic,” said Amit Shah, CFO of Oncotelic. “We expect FY 2022 to be more exciting, with the completion and the evolution of our JV so that the OT-101 asset can be developed rapidly. At the same time, we shall be leveraging on our previous successes along the 505(b)2 strategy for the development of AL-101 as our lead fast to market drug candidate for the Company. Going forward, with the cash requirement of the Company significantly reduced due to unburdening the development and commercialization cost of OT-101, we anticipate our operational expenses will reduce significantly. We are also contemplating and evaluating uplisting the Company to a national stock exchange to complete the corporate turnaround."
Additional information is included in the Company’s Form 10-K for the year ended December 31, 2021, filed on April 15, 2022, a copy of which is available free of charge at http://investor.Oncotelic.com/sec-filings.
Recent Corporate Update
On March 31, 2022, we completed the formation of a JV, with Dragon Overseas, called GMP Bio. Dragon Overseas and GMP Bio are affiliated with GMP. “As previously announced, we are excited to begin this new and exciting partnership with Dragon Overseas, with whom we have formed a JV for the discovery, development and commercialization of TGF-β therapeutics against all pharmaceutical indications for OT-101,” said Dr. Vuong Trieu, CEO and Chairman of Oncotelic. “Now that we have achieved our first objective for out-licensing OT-101, we will be looking to repositioning CA4P and Oxi4503 and maximizing their values to shareholders. Steve King – our BOD- and myself were part of the team under the late Dr. Phil Thorpe who founded Vascular Disruption Agent (“VDA”) in 1997 – and we look forward to revitalize the field as originally envisioned by Dr. Thorpe.”
Additional information as to corporate strategy and additional information on the JV can be found at:
https://www.youtube.com/watch?v=sr3qbea_mCM&t=35s
https://www.youtube.com/watch?v=Ys4V5qZt4sA&t=19s
Analyst comment on the JV can be found at: https://www.oncotelic.com/wp-content/uploads/2022/03/OTLC-JV-update.pdf
Other highlights of the transaction include:
- Oncotelic to receive up to
$50 million on sale of the RPD voucher following marketing approval of OT-101 for diffuse intrinsic pontine glioma, or DIPG. - Dragon Overseas has agreed to invest cash and other assets with a value of approximately
$27.6 million for55% ownership of the JV. - Oncotelic has licensed OT-101 to the JV for a
45% ownership in the JV. - The JV to be headquartered in Hong Kong.
- Initial focus on the further development and commercialization of OT-101, including for DIPG as well as pancreatic cancers and glioblastoma.
- The JV is planned to be taken into an IPO at a future point in time.
Recent Product Development Highlights
AL-101 CNS Program
AL-101 (intranasal apomorphine), is our lead fast-to-market 505(b)2 regulatory pathway drug candidate for Parkinson Disease (“PD”) and Erectile Dysfunction (“ED”), especially phosphodiesterase 5 (“PDE5”) non-responders. Oncotelic also plans to develop AL-101 as a new class of drug against Female Sexual Dysfunction (“FSD”), including Hypoactive Sexual Desire Disorder (“HSDD”). Through targeting the dopamine receptors in the brain AL-101 has multiple central nervous system effects that will be leveraged in its development - mirroring the successes we have had previously with Abraxane™ and Cynviloq™ via the 505(b)2 pathway. AL-101 has shown a favorable safety and efficacy profile and is phase 3 ready with six clinical trials completed and over 200 patients (2,200 doses) treated.
With over 60,000 new patients annually being diagnosed with PD in the United States. Currently there are over 1 million patients in the US and expected to increase to over 1.2 million by 2030. In addition, approximately 10 million suffer from this disease globally. https://www.parkinson.org/Understanding-Parkinsons/Statistics. As reported by Pharmaceutical Technology by GlobalData Healthcare on May 26, 2020, KYNMOBI™ (apomorphine HCI) sublingual film was approved through the 505(b)2 pathway for acute, intermittent treatment of OFF episodes in patients with PD. KYNMOBI™ dissolves under the tongue. Per GlobalData Healthcare, KYNMOBI™ is expected to generate
ED is the most prevalent male sexual disorder globally. The percentages of men affected by ED are as follows: 14.3
FSD is a prevalent problem, afflicting approximately
OT-101/PD-1 Oncology Program
The OT-101/PD-1 program is designed to assess the impact of OT-101 across multiple cancer indications, where local tumoral secretion of transforming growth factor-beta (“TGF-β”) suppressed the clinical activity of checkpoint inhibitors, CAR-T, and vaccines. Multiple phase 2 trials combination of OT-101, with a PD-1 inhibitor, in collaboration with large pharmaceutical company, and leading KOLs around the world, are being planned and developed. These trials span mesothelioma, glioblastoma, lung, and colorectal cancers where AI driven transcriptome analyses will be used to derive the predictive and prognostic biomarker for TGF-β therapeutics, including OT-101.
TGF- β promotes immune evasion. The different components surrounding a tumor are collectively known as the tumor microenvironment (TME). The TGF-β signaling pathway is activated in the TME and the tumor, leading to alteration in the composition of the TME that favors tumor growth and aggressiveness. A major component of the TME, called Cancer-Associated Fibroblasts. help the tumor grow and escape destruction by the host immune system. As such even if an immune cell is sitting next to the tumor cells, it would not do anything because the tumor is making so much TGF, essentially cloaking the tumors. OT-101 inhibits the making TGF- β protein.
A PD-1 inhibitor, such as pembroluzimab, is not chemotherapy or radiation therapy — it is an immunotherapy and it works with our immune system to help fight cancer. Immunotherapy is spectacularly effective. These agents mobilize the immune system to attack the tumor and achieve cure (not just slowing down of the tumor/remission). However, it will work in only about
OT-101/IL-2 Oncology Program
Our OT-101/IL-2 combination trial (the “Trial”), has now successfully completed the safety evaluation of its safety cohort, allowing for further expansion of its clinical program into phase 2 and higher doses.
The Trial - A Multi-center, Open label, Phase Ib clinical study to evaluate the safety, tolerance, and efficacy of TASO-001 (“OT-101”), a TGF-β targeting anti-sense oligonucleotide, in combination with recombinant interleukin-2 (Aldesleukin, “IL-2”), in patients with advanced or metastatic solid tumor cancer. ClinicalTrials.gov Identifier: NCT04862767. The Trial is being conducted by Autotelic BIO, a partner of Oncotelic on the OT-101/IL-2 combination.
In the safety cohort treated during the Trial, the standard dosage of 140mg/m2 of OT-101was well tolerated in combination with IL-2, which has allowed for ongoing dose escalation to 190 mg/m2. The 140 mg/m2 dose was shown to be the optimal dose for OT-101 in a prior trial targeting pancreatic cancer, melanoma, and colorectal cancer (“P001”). In the P001 trial, the maximum tolerated dose was not reached even at 330 mg/m2. Therefore, the Company believes that increasing the dose above 140 mg/m2 should further enhance the clinical activity of OT-101.
OT-101 COVID-19 program
On October 18, the data lock of the Study Data and Analysis Data Models (SDTMs & ADaMS Databases) were generated for the Company’s C001 trial for COVID-19. The trial compares OT-101 plus standard of care (“SOC”) versus Placebo plus SOC, the SOC which includes dexamethasone (N= 32 pts at 2:1 randomization ratio). Dexamethasone is the only known drug to improve outcome for severe COVID-19. The top line data as previously disclosedare:
Safety endpoints met. OT-101 as a TGF-β inhibitor was safe to administer to COVID-19 patients including severe/critical COVID-19 patients.
Efficacy signals were obtained. End of treatment- Day 7-mortality for the entire study population was
Incidence of >
Overall survival improved significantly improved from 4 day for placebo to 14 day OT-101 among critically ill COVID-19 patients.
The data form the basis for us to further develop this as a drug to treat severe respiratory viral infections including flu and COVID. Both tumor cells and the SARS-CovCoV-2 viruses induce TGF-β as part of their immune evasion mechanism. Consequently, inhibiting TGF-β by OT-101 is expected to impact both cancer and COVID. By targeting the host protein, OT-101 is expected to work against multiple respiratory viruses agnostic of the emerging variants, unlike traditional antiviral drugs and vaccines.
Artemisinin COVID-19 Program
We deployed Artemisinin as herbal supplement in India under the name PulmoHeal™ together with Chopra Foundation and Heart Care Foundation of India (HCFI) and Parmarth Niketan Ashram to combat COVID during the deadly surge in COVID-19 in summer of 2021 as a humanitarian effort. As we build our patent portfolio around Artemisinin and its analogs for COVID-19 and other respiratory viral infections we are positioning Artemisinin and its analog artesunate as pharmaceutics.
About Oncotelic
Oncotelic (f/k/a Mateon Therapeutics, Inc.), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi 4503). Oncotelic also acquired PointR Data Inc. in November 2019.
Additionally, Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of PD. Over 60,000 new patients are being diagnosed with PD in the United States. Currently there are over 1 million patients in the US and expected to increase to over 1.2 million by 2030. In addition, approximately 10 million suffer from this disease globally. https://www.parkinson.org/Understanding-Parkinsons/Statistics. AL-101 is also being developed for ED. ED is the most prevalent male sexual disorder globally. The percentages of men affected by ED are as follows: 14.3
For more information, please visit www.oncotelic.com
Oncotelic's Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as "may", "expect", "anticipate" "hope", "vision", "optimism", "design", "exciting", "promising", "will", "conviction", "estimate," "intend," "believe", "quest for a cure of cancer", "innovation-driven", "paradigm-shift", "high scientific merit", "impact potential" and similar expressions are intended to identify forward-looking statements. Forward¬ looking statements contained in this press release include, but are not limited to, statements about future plans related to the operations of the JV, taking the JV into an initial public offering or the success thereof, the progress, timing of clinical development, scope and success of future clinical trials of any of our products, the reporting of clinical data for the company's product candidates and the potential use of the company's product candidates to treat various cancer indications as well as obtaining required regulatory approval to conduct clinical trials and upon granting of approval by the regulatory agencies, the successful marketing of the products, the ability to raise any additional funds for the Company to develop our other products, the ability to get uplisted to a national stock exchange. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the Company's annual report on Form 10-K filed with the SEC on April 15, 2021 and in the company's other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information future events, or otherwise.
Contact Information:
For Oncotelic Therapeutics, Inc.:
Amit Shah
ashah@oncotelic.com
FAQ
What were Oncotelic's financial results for FY 2021?
Did Oncotelic generate any service revenue in FY 2021?
What is the significance of Oncotelic's joint venture with Dragon Overseas?
What impact did the formation of the joint venture have on Oncotelic's future outlook?