Oncotelic Provides Ye 2021 Financial Results Compared To Ye 2020, Product Developmet Initiatives And Corporate Update

AGOURA HILLS, Calif., April 18, 2022 (GLOBE NEWSWIRE) — Oncotelic Therapeutics, Inc. (“Oncotelic”, “We” or the “Firm”) (OTCQB:OTLC) at the moment introduced monetary outcomes for the total 12 months ended December 31, 2021 (“FY 2021”) as in comparison with the total 12 months ended December 31, 2020 (“FY 2020”), an replace on its product and therapeutic improvement initiatives and different company updates. The monetary outcomes had been based mostly on the 2021 Annual Report on Kind 10-Ok filed with the Securities and Change Fee on April 15, 2022.

FY 2021 in comparison with FY 2020 Monetary Outcomes Overview

ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE YEAR ENDED DECEMBER 31

Internet Loss

We recorded a internet lack of roughly $10.5 million for FY 2021, in comparison with a internet lack of roughly $10 million for FY 2020. The elevated loss from operations was on account of decreased revenues of roughly $1.7 million, generated throughout FY 2020 as towards no revenues throughout the FY 2021, offset by operational bills of roughly $0.2 million. As well as, a part of the working loss was offset by roughly $0.3 million for the PPP mortgage forgiveness, roughly $0.3 million of a decrease loss on conversion of debt and roughly $0.3 million for change in worth of derivatives recorded throughout FY 2021 as in contrast FY 2020.

Income

We recorded providers income of $0 for FY 2021 as in comparison with roughly $1.7 million throughout FY 2020. The providers income recorded in 2020 primarily comprised of $1.2 million from providers offered to Golden Mountain Companions (“GMP”) in reference to the event of OT-101 for COVID-19. We additionally recorded $0.5 million of revenues from Autotelic Bio upon the profitable completion of the in-vivo efficacy research based mostly on the settlement between Oncotelic and Autotelic Bio.

Analysis and Improvement Expense

Analysis and Improvement (“R&D”) expense decreased by roughly $0.6 million, from roughly $4.3 million for FY 2020 as in comparison with roughly $3.7 million for FY 2021. The lower of roughly $0.6 million within the R&D actions was primarily on account of decreased medical trial prices of $0.3 million for the trials for OT-101 and Artemisinin, and $0.4 million for decrease operational prices.

Common and Administrative Expense

Common and administrative (“G&A”) expense elevated by roughly $0.4 million, from roughly $5.4 million for FY 2021 as in comparison with $5.0 for FY 2020. The rise in G&A bills was primarily on account of roughly $1 million of upper non-cash equity-based bills, partially offset by decrease compensation prices of roughly $0.3 million, decrease authorized {and professional} prices of roughly $0.2 million and decrease different operational prices of roughly $0.1 million.

Change in worth of derivatives

Throughout FY 2021, we recorded a acquire of $0.3 million as a result of change in worth of derivatives on sure notes. Correspondingly, throughout FY 2020, we recorded a nominal loss as a result of change in worth of derivatives of $45 thousand on sure notes.

Curiosity Expense

We recorded curiosity expense, together with amortization of debt prices, of $2.0 million for FY 2021 in reference to debt raised from the varied convertible notes and a non-public placement memorandum as in comparison with $2.0 million on convertible notes and a portion of the non-public placement memorandum for FY 2020.

Liquidity, Monetary Situation and Capital Sources ($s in ‘000’s)

As the tip of FY 2021, the Firm had roughly $0.6 million in money and present liabilities of roughly $15.5 million. Because the Firm efficiently established the three way partnership with Dragon Abroad, the Firm is predicted to cut back its bills considerably.

Money Flows ($s in ‘000s)

Working Actions

Internet money utilized in working actions was roughly $4.3 million for FY 2021. This was as a result of internet lack of roughly $10.5 million, which was partially offset by a $1.5 million of R&D price paid by way of debt from GMP, non-cash amortization of debt reductions and deferred financing prices of $1.4 million, non-cash stock-based compensation of $0.8 million, amortization and depreciation of intangibles and improvement gear of $0.1 million, non-cash acquire on conversion of debt and alter in truthful worth of derivatives of $0.3 million, forgiveness of the PPP Mortgage of $0.3 million and adjustments in working property and liabilities of roughly $0.2 million.

Financing Actions

For FY 2021, internet money offered by financing actions was roughly $4.4 million. Internet money offered was on account of roughly $1.6 million raised from the JH Darbie Financing, $0.1 million acquired below the Payroll Safety Plan, $0.4 million raised from sale of widespread inventory below the fairness buy settlement with Peak One, roughly $2.8 million raised by way of issuance of convertible debt, together with roughly $1.25 million from 5 institutional traders, $0.7 million from the CEO, the CFO and a couple of bridge traders, $0.5 million of convertible debt offered by GMP, and $0.4 million of different quick time period loans offset by compensation of $0.4 million of convertible debt on account of Geneva and compensation of $0.2 million of different notes.

Highlights for Q4 2021 and thereafter:

In October 2021, the Firm entered into an unsecured convertible notice buy settlement with GMP, pursuant to which the Firm issued a convertible promissory notice within the combination principal quantity of $0.5 million, which notice is convertible into shares of the Firm’s Widespread Inventory. In January 2022, the Firm entered into an unsecured convertible notice buy settlement with GMP, pursuant to which the Firm issued a convertible promissory notice within the combination principal quantity of $0.5 million, which notice is convertible into shares of the Firm’s Widespread Inventory. The Firm entered right into a three way partnership (“JV”) with Dragon Abroad Capital Restricted (“Dragon Abroad”) and GMP Biotechnology Restricted (“GMP Bio”), each associates of GMP, on March 31, 2022. GMP Bio might be owned by Dragon Abroad and the Firm in a 55% to 45% ratio, respectively. Dragon Abroad will contribute about $28 million in money and property into GMP Bio and the Firm will enter the licenses for OT-101 for US and Ex-US rights into GMP Bio. GMP Bio will develop OT-101 for a number of oncology pharmaceutical indications.

In September 2021, the Firm entered into an unique License Settlement (the “Settlement”) with Autotelic, Inc. (“Autotelic”), pursuant to which Autotelic granted the Firm the unique proper and license to sure Autotelic Patents and Know-How and a proper of first refusal to accumulate a minimum of a majority of the excellent capital inventory of Autotelic previous to Autotelic getting into into any transaction as outlined within the settlement. In alternate for the rights granted to Oncotelic, Autotelic might be entitled to earn the milestone funds of as much as $50 million upon achievement of sure monetary, improvement and regulatory milestones and royalties equal to fifteen% of the web gross sales of any merchandise that incorporate the Autotelic Patents or Autotelic Know-How. With the outlicensing of OT-101 to the JV, AL-101 would be the Firm’s major product for improvement towards Parkinson’s Illness, erectile dysfunction and feminine sexual dysfunction.

In November and December 2021, the Firm entered into securities buy settlement with 5 institutional traders, whereby the Firm issued 5 convertible notes within the combination principal quantity of $1,250,000 convertible into shares of widespread inventory of the Firm. The convertible notes carry a twelve (12%) p.c coupon and a default coupon of 16% and mature on the earliest of 1 12 months from issuance or upon occasion of default. Traders have the proper at any time following issuance date to transform all or any a part of the excellent and unpaid quantity of the notice into the Firm’s widespread inventory at a conversion value established at a set fee of $0.07. The Firm granted a complete variety of 9,615,385 warrants convertible into an equal variety of the Firm widespread shares at a strike value of $0.13 as much as 5 years after issuance. The Placement agent was additionally granted a complete quantity of 961,540 as a part of a finder’s charge settlement. Additional, on March 29, 2022, the Firm entered right into a securities buy settlement, notice and issued warrants to buy 1.250,000 shares of the Widespread Inventory with one of many 5 institutional traders for an extra $250,000 of gross proceeds. The phrases of the securities purchases agreements and notes are the identical as these contained within the November/December 2021 agreements and notes, besides with references to the conversion value of the notes growing to $0.10 from $0.07 and the warrant train value to $0.20 from $0.13.

“FY 2021 was a difficult, however an thrilling 12 months for all of us at Oncotelic,” mentioned Amit Shah, CFO of Oncotelic. “We anticipate FY 2022 to be extra thrilling, with the completion and the evolution of our JV in order that the OT-101 asset will be developed quickly. On the similar time, we will be leveraging on our earlier successes alongside the 505(b)2 technique for the event of AL-101 as our lead quick to market drug candidate for the Firm. Going ahead, with the money requirement of the Firm considerably decreased on account of unburdening the event and commercialization price of OT-101, we anticipate our operational bills will scale back considerably. We’re additionally considering and evaluating uplisting the Firm to a nationwide inventory alternate to finish the company turnaround.”

Further info is included within the Firm’s Kind 10-Ok for the 12 months ended December 31, 2021, filed on April 15, 2022, a replica of which is obtainable freed from cost at http://investor.Oncotelic.com/sec-filings.

Latest Company Replace

On March 31, 2022, we accomplished the formation of a JV, with Dragon Abroad, referred to as GMP Bio. Dragon Abroad and GMP Bio are affiliated with GMP. “As beforehand introduced, we’re excited to start this new and thrilling partnership with Dragon Abroad, with whom now we have fashioned a JV for the invention, improvement and commercialization of TGF-β therapeutics towards all pharmaceutical indications for OT-101,” mentioned Dr. Vuong Trieu, CEO and Chairman of Oncotelic. “Now that now we have achieved our first goal for out-licensing OT-101, we might be seeking to repositioning CA4P and Oxi4503 and maximizing their values to shareholders. Steve King – our BOD- and myself had been a part of the group below the late Dr. Phil Thorpe who based Vascular Disruption Agent (“VDA”) in 1997 – and we stay up for revitalize the sector as initially envisioned by Dr. Thorpe.”

Further info as to company technique and extra info on the JV will be discovered at:

https://www.youtube.com/watch?v=sr3qbea_mCM&t=35s

https://www.youtube.com/watch?v=Ys4V5qZt4sA&t=19s

Analyst touch upon the JV will be discovered at: https://www.oncotelic.com/wp-content/uploads/2022/03/OTLC-JV-update.pdf

Different highlights of the transaction embody:

• Oncotelic to obtain as much as $50 million on sale of the RPD voucher following advertising and marketing approval of OT-101 for diffuse intrinsic pontine glioma, or DIPG.
• Dragon Abroad has agreed to speculate money and different property with a worth of roughly $27.6 million for 55% possession of the JV.
• Oncotelic has licensed OT-101 to the JV for a forty five% possession within the JV.
• The JV to be headquartered in Hong Kong.
• Preliminary concentrate on the additional improvement and commercialization of OT-101, together with for DIPG in addition to pancreatic cancers and glioblastoma.
• The JV is deliberate to be taken into an IPO at a future cut-off date.

Latest Product ImprovementHighlights

AL-101 CNS Program

AL-101 (intranasal apomorphine), is our lead fast-to-market 505(b)2 regulatory pathway drug candidate for Parkinson Illness (“PD”) and Erectile Dysfunction (“ED”), particularly phosphodiesterase 5 (“PDE5”) non-responders. Oncotelic additionally plans to develop AL-101 as a brand new class of drug towards Feminine Sexual Dysfunction (“FSD”), together with Hypoactive Sexual Need Dysfunction (“HSDD”). By means of concentrating on the dopamine receptors within the mind AL-101 has a number of central nervous system results that might be leveraged in its improvement – mirroring the successes now we have had beforehand with Abraxane^™ and Cynviloq^™ by way of the 505(b)2 pathway. AL-101 has proven a good security and efficacy profile and is section 3 prepared with six medical trials accomplished and over 200 sufferers (2,200 doses) handled.

With over 60,000 new sufferers yearly being identified with PD in the USA. At present there are over 1 million sufferers within the US and anticipated to extend to over 1.2 million by 2030. As well as, roughly 10 million endure from this illness globally. https://www.parkinson.org/Understanding-Parkinsons/Statistics. As reported by Pharmaceutical Expertise by GlobalData Healthcare on Could 26, 2020, KYNMOBI^™ (apomorphine HCI) sublingual movie was permitted by way of the 505(b)2 pathway for acute, intermittent remedy of OFF episodes in sufferers with PD. KYNMOBI^™ dissolves below the tongue. Per GlobalData Healthcare, KYNMOBI^™ is predicted to generate $219 million yearly. https://www.pharmaceutical-technology.com/comment/sunovion-pharmaceuticals-kynmobi-parkinsons/. We anticipate AL-101 to be a superior product based mostly on speedy and preferential accumulation within the mind.

ED is essentially the most prevalent male sexual dysfunction globally. The odds of males affected by ED are as follows: 14.3-70% of males aged ≥60 years, 6.7-48% of males aged ≥70 years, and 38% of males aged ≥80 years (Geerkens MJM et al. (2019). Eur Urol Focus. pii: S2405-4569(19)30079-3).

FSD is a prevalent drawback, afflicting roughly 40% of girls and there are few accessible remedy choices. In June 2019, the U.S. Meals and Drug Administration permitted Vyleesi (bremelanotide) to deal with acquired, generalized HSDD in premenopausal ladies. At present, that is the one accessible drug remedy. Vyleesi has primarily changed the one different drug for HSDD – nevertheless, it has an extended listing of drug-drug interactions, together with generally used antidepressants, comparable to fluoxetine and sertraline. As well as, it has a black field warning relating to its use with alcohol, a mix that has been related to hypotension and syncopal episodes. Due to this fact, there may be an pressing want for an efficient remedy towards FSD and HSDD.

OT-101/PD-1 Oncology Program

The OT-101/PD-1 program is designed to evaluate the affect of OT-101 throughout a number of most cancers indications, the place native tumoral secretion of remodeling progress factor-beta (“TGF-β”) suppressed the medical exercise of checkpoint inhibitors, CAR-T, and vaccines. A number of section 2 trials mixture of OT-101, with a PD-1 inhibitor, in collaboration with giant pharmaceutical firm, and main KOLs all over the world, are being deliberate and developed. These trials span mesothelioma, glioblastoma, lung, and colorectal cancers the place AI pushed transcriptome analyses might be used to derive the predictive and prognostic biomarker for TGF-β therapeutics, together with OT-101.

TGF- β promotes immune evasion. The totally different elements surrounding a tumor are collectively generally known as the tumor microenvironment (TME). The TGF-β signaling pathway is activated within the TME and the tumor, resulting in alteration within the composition of the TME that favors tumor progress and aggressiveness. A serious part of the TME, referred to as Most cancers-Related Fibroblasts. assist the tumor develop and escape destruction by the host immune system. As such even when an immune cell is sitting subsequent to the tumor cells, it might not do something as a result of the tumor is making a lot TGF, primarily cloaking the tumors. OT-101 inhibits the making TGF- β protein.

A PD-1 inhibitor, comparable to pembroluzimab, will not be chemotherapy or radiation remedy — it’s an immunotherapy and it really works with our immune system to assist combat most cancers. Immunotherapy is spectacularly efficient. These brokers mobilize the immune system to assault the tumor and obtain treatment (not simply slowing down of the tumor/remission). Nonetheless, it would work in solely about 10% of sufferers. The remainder have an excessive amount of TGF- β for PD-1 immunotherapy to be efficient. Flattening TGF with OT-101 ought to enhance the treatment fee above the ten%. We hope that treatment fee can attain 100% sooner or later.

OT-101/IL-2 Oncology Program

Our OT-101/IL-2 mixture trial (the “Trial”), has now efficiently accomplished the security analysis of its security cohort, permitting for additional growth of its medical program into section 2 and better doses.

The Trial – A Multi-center, Open label, Part Ib medical research to guage the security, tolerance, and efficacy of TASO-001 (“OT-101”), a TGF-β concentrating on anti-sense oligonucleotide, together with recombinant interleukin-2 (Aldesleukin, “IL-2”), in sufferers with superior or metastatic strong tumor most cancers. ClinicalTrials.gov Identifier: NCT04862767. The Trial is being performed by Autotelic BIO, a companion of Oncotelic on the OT-101/IL-2 mixture.

Within the security cohort handled throughout the Trial, the usual dosage of 140mg/m2 of OT-101was properly tolerated together with IL-2, which has allowed for ongoing dose escalation to 190 mg/m2. The 140 mg/m2 dose was proven to be the optimum dose for OT-101 in a previous trial concentrating on pancreatic most cancers, melanoma, and colorectal most cancers (“P001”). Within the P001 trial, the utmost tolerated dose was not reached even at 330 mg/m2. Due to this fact, the Firm believes that growing the dose above 140 mg/m2 ought to additional improve the medical exercise of OT-101.

OT-101COVID-19 program

On October 18, the info lock of the Research Information and Evaluation Information Fashions (SDTMs & ADaMS Databases) had been generated for the Firm’s C001 trial for COVID-19. The trial compares OT-101 plus normal of care (“SOC”) versus Placebo plus SOC, the SOC which incorporates dexamethasone (N= 32 pts at 2:1 randomization ratio). Dexamethasone is the one identified drug to enhance final result for extreme COVID-19. The highest line information as beforehand disclosedare:

Security endpoints met. OT-101 as a TGF-β inhibitor was secure to manage to COVID-19 sufferers together with extreme/vital COVID-19 sufferers.

Efficacy indicators had been obtained. Finish of treatment- Day 7-mortality for all the research inhabitants was 4.5% OT-101 versus 20% Placebo.

Incidence of >96% viral load knockdown on Finish of Remedy- Day 7- was 89% for OT-101 versus 67% for placebo.

Total survival improved considerably improved from 4 day for placebo to 14 day OT-101 amongst critically in poor health COVID-19 sufferers.

The info type the idea for us to additional develop this as a drug to deal with extreme respiratory viral infections together with flu and COVID. Each tumor cells and the SARS-CovCoV-2 viruses induce TGF-β as a part of their immune evasion mechanism. Consequently, inhibiting TGF-β by OT-101 is predicted to affect each most cancers and COVID. By concentrating on the host protein, OT-101 is predicted to work towards a number of respiratory viruses agnostic of the rising variants, not like conventional antiviral medication and vaccines.

ArtemisininCOVID-19 Program

We deployed Artemisinin as natural complement in India below the identify PulmoHeal^™ along with Chopra Basis and Coronary heart Care Basis of India (HCFI) and Parmarth Niketan Ashram to fight COVID throughout the lethal surge in COVID-19 in summer time of 2021 as a humanitarian effort. As we construct our patent portfolio round Artemisinin and its analogs for COVID-19 and different respiratory viral infections we’re positioning Artemisinin and its analog artesunate as pharmaceutics.

About Oncotelic

Oncotelic (f/ok/a Mateon Therapeutics, Inc.), was fashioned within the State of New York in 1988 as OXiGENE, Inc., was reincorporated within the State of Delaware in 1992, and altered its identify to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is searching for to leverage its deep experience in oncology drug improvement to enhance remedy outcomes and survival of most cancers sufferers with a particular emphasis on uncommon pediatric cancers. Oncotelic has uncommon pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi 4503). Oncotelic additionally acquired PointR Information Inc. in November 2019.

Moreover, Oncotelic acquired AL-101, throughout the 4th quarter of 2021, for the intranasal supply of apomorphine. We intend to develop AL-101 for the remedy of PD. Over 60,000 new sufferers are being identified with PD in the USA. At present there are over 1 million sufferers within the US and anticipated to extend to over 1.2 million by 2030. As well as, roughly 10 million endure from this illness globally. https://www.parkinson.org/Understanding-Parkinsons/Statistics. AL-101 can be being developed for ED. ED is essentially the most prevalent male sexual dysfunction globally. The odds of males affected by ED are as follows: 14.3-70% of males aged ≥60 years, 6.7-48% of males aged ≥70 years, and 38% of males aged ≥80 years (Geerkens MJM et al. (2019). Eur Urol Focus. pii: S2405-4569(19)30079-3). Nonetheless, with the growing administration of PDE5 inhibitors in medical apply, it was discovered that roughly 30-35% of ED sufferers are remedy failures (McMahon CN et al. (2006). BMJ, 332: 589-92). AL-101 is designed to focus on remedy failure ED sufferers who don’t reply to PDE5 inhibitors. By means of comparable mechanism of motion, AL-101 is being developed for FSD. Feminine sexual dysfunction is a prevalent drawback, afflicting roughly 40% of girls and there are few remedy choices. FSD is extra typical as ladies age and is a progressive and widespread situation. (Allahdadi, KJ et al. (2009) Cardiovascular & hematological brokers in medicinal chemistry, 7(4), 260–269). There isn’t a accessible drug for the remedy of FSD. In June 2019, the U.S. Meals and Drug Administration permitted Vyleesi (bremelanotide) to deal with acquired, generalized HSDD in premenopausal ladies. That is the one accessible drug remedy. Vyleesi has primarily changed the one different drug for HSDD – nevertheless, it has an extended listing of drug-drug interactions, together with generally used antidepressants, comparable to fluoxetine and sertraline. As well as, it has a black field warning relating to its use with alcohol, a mix that has been related to hypotension and syncopal episodes. Due to this fact, there may be an pressing want for efficient remedy towards FSD and HSDD.

For extra info, please go to www.oncotelic.com

Oncotelic’s Cautionary Be aware on Ahead-Trying Statements

This press launch accommodates forward-looking statements throughout the that means of the Non-public Securities Litigation Reform Act of 1995. All statements, aside from statements of historic info, included on this communication relating to technique, future operations, future monetary place, prospects, plans and goals of administration are forward-looking statements. Phrases comparable to “might”, “anticipate”, “anticipate” “hope”, “imaginative and prescient”, “optimism”, “design”, “thrilling”, “promising”, “will”, “conviction”, “estimate,” “intend,” “imagine”, “quest for a treatment of most cancers”, “innovation-driven”, “paradigm-shift”, “excessive scientific advantage”, “affect potential” and comparable expressions are meant to establish forward-looking statements. Ahead¬ wanting statements contained on this press launch embody, however are usually not restricted to, statements about future plans associated to the operations of the JV, taking the JV into an preliminary public providing or the success thereof, the progress, timing of medical improvement, scope and success of future medical trials of any of our merchandise, the reporting of medical information for the corporate’s product candidates and the potential use of the corporate’s product candidates to deal with numerous most cancers indications in addition to acquiring required regulatory approval to conduct medical trials and upon granting of approval by the regulatory businesses, the profitable advertising and marketing of the merchandise, the flexibility to boost any further funds for the Firm to develop our different merchandise, the flexibility to get uplisted to a nationwide inventory alternate. Every of those forward-looking statements entails dangers and uncertainties, and precise outcomes might differ materially from these forward-looking statements. Many components might trigger variations between present expectations and precise outcomes, together with sudden security or efficacy information noticed throughout preclinical or medical research, medical trial web site activation or enrollment charges which might be decrease than anticipated, adjustments in anticipated or present competitors, adjustments within the regulatory atmosphere, failure of collaborators to help or advance collaborations or product candidates and sudden litigation or different disputes. These dangers are usually not exhaustive, the corporate faces identified and unknown dangers, together with the chance components described within the Firm’s annual report on Kind 10-Ok filed with the SEC on April 15, 2021 and within the firm’s different periodic filings. Ahead-looking statements are based mostly on expectations and assumptions as of the date of this press launch. Besides as required by legislation, the corporate doesn’t assume any obligation to replace forward-looking statements contained herein to replicate any change in expectations, whether or not on account of new info future occasions, or in any other case.

Contact Info:

For Oncotelic Therapeutics, Inc.:

Amit Shah

ashah@oncotelic.com