-
Introduced Thorough Analysis of a Vary of Potential Strategic Opportunities
-
Continued GBM Examine Begin-up Actions
-
Ended Quarter with $25.9 million in Money, Money Equivalents and Marketable Securities
CHARLOTTESVILLE, Va., Nov. 14, 2022 (GLOBE NEWSWIRE) — Diffusion Prescription drugs Inc. (NASDAQ: DFFN) (“Diffusion” or the “Firm”), a biopharmaceutical firm growing novel therapies that will improve the physique’s skill to ship oxygen to areas the place it’s wanted most, at the moment introduced monetary outcomes for the quarter ended September 30, 2022, and supplied a enterprise replace.
“As beforehand introduced, we formalized our efforts to determine and consider strategic alternatives through the third quarter, and with our present property, together with trans sodium crocetinate (“TSC”) and our robust steadiness sheet, we imagine these actions will successfully place us to satisfy the challenges of this dynamic market,” commented Robert Cobuzzi, Jr., Ph.D., President and Chief Govt Officer of Diffusion.
Dr. Cobuzzi continued, “Whereas our course of to judge strategic alternatives is ongoing, the Diffusion group stays targeted on executing our technique to create worth for our shareholders. We proceed to prioritize progress in direction of the initiation of Examine 200-208 and additional exploration of potential accelerated pathways for regulatory approval of TSC, whereas taking steps to protect capital with out sacrificing significant progress alternatives.”
Enterprise & Growth Updates
Commenced Course of to Consider Potential Strategic Opportunities: In October 2022, Diffusion introduced that its Board of Administrators licensed an intensive evaluate and analysis of a variety of potential strategic alternatives within the curiosity of enhancing stockholder worth together with transactional alternatives to raised leverage the potential of TSC and the Firm’s different property. The Firm retained Canaccord Genuity LLC as its monetary advisor and Dechert LLP as its authorized counsel to help with the evaluate course of.
Introduced Plans for a Section 2 Glioblastoma Trial: In July 2022, Diffusion introduced alignment with the USA Meals and Drug Administration (“FDA”) on the design of Diffusion’s Section 2 scientific trial entitled “Open-Label, Dose-Escalation, Section 2 Security and Efficacy Examine of TSC in Newly Recognized Glioblastoma (“GBM”) Sufferers when Administered with Normal of Care.” The examine will embrace as much as 9 sufferers in a dose-escalation section, enrolling sufferers in a 3+3+3 design, to judge the protection, tolerability, pharmacokinetics, and pharmacodynamics of TSC at doses of 1.5 mg/kg, 2.0 mg/kg and a pair of.5 mg/kg administered together with concomitant normal of care radiotherapy plus temozolomide. An extra 17 topics can be handled on the highest tolerable dose recognized within the dose escalation section. The first goal of the examine is to judge the general survival of sufferers with newly recognized GBM when handled with TSC administered with normal of care. Secondary goals of the examine are to judge progression-free survival at six months and 7 months by magnetic resonance imaging, evaluation utilizing Response Evaluation in Neuro-Oncology standards. The trial will incorporate an revolutionary use of Positron Emission Tomography (“PET”) imaging to acquire an early learn on TSC’s results by straight evaluating the consequences of TSC on tumor hypoxia, with preliminary knowledge readouts from the dose-escalation section of the examine anticipated to be accessible inside one yr of the primary affected person being dosed.
Monetary Updates
Analysis and improvement bills within the third quarter of 2022 had been $0.8 million, in comparison with $2.1 million within the prior yr interval. This lower was attributable to the timing of scientific trials and drug manufacturing, in addition to a vendor-related refund.
Normal and administrative bills had been $2.1 million through the third quarter of 2022 versus $1.9 million within the comparable quarter final yr. The rise primarily displays an increase in exterior companies associated to the continued enterprise improvement actions.
As of September 30, 2022, Diffusion had $25.9 million in money, money equivalents, and marketable securities, which the Firm at present expects will allow it to fund its working bills and capital expenditure necessities into the primary quarter of 2024, with out giving impact to the end result and timing of the Firm’s ongoing strategic evaluate course of.
About Diffusion Prescription drugs Inc.
Diffusion Prescription drugs Inc. is a biopharmaceutical firm growing novel therapies to boost the physique’s skill to ship oxygen to areas the place it’s wanted most. Diffusion’s lead product candidate, TSC, is being investigated to boost the diffusion of oxygen to tissues with low oxygen ranges, often known as hypoxia, a critical complication of many of drugs’s most intractable and difficult-to-treat situations, together with hypoxic strong tumors like GBM. For extra info, please go to us at www.diffusionpharma.com.
Ahead-Wanting Statements
This press launch contains specific and implied forward-looking statements throughout the which means of the Non-public Securities Litigation Reform Act of 1995, as amended, together with: the timing and potential end result of the Firm’s ongoing strategic various evaluate course of; the potential therapeutic worth of TSC in most cancers and non-cancer indications; anticipated timelines for the initiation, completion, and announcement of information from Examine 200-208; the Firm’s ongoing and deliberate scientific trials; the Firm’s near-term strategic priorities with respect to the event of TSC and in any other case; and the Firm’s anticipated money runway. The Firm might, in some instances, use phrases corresponding to “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “might,” “might,” “may,” “will,” “ought to,” “roughly,” or different phrases that convey uncertainty of future occasions or outcomes to determine these forward-looking statements. Though the Firm believes that it has an affordable foundation for every forward-looking assertion contained herein, forward-looking statements by their nature contain dangers and uncertainties, recognized and unknown, lots of that are past the Firm’s management and, because of this, the Firm’s precise outcomes might differ materially from these expressed or implied in any forward-looking assertion. Explicit dangers and uncertainties embrace, amongst different issues, these associated to: the Firm’s ongoing strategic various evaluate course of and the Firm’s skill to determine, consider and execute potential enterprise improvement transactional alternatives, if any; the novelty of the Firm’s Examine 200-208 design, the relevance of traits noticed in any PET scan knowledge readouts the Firm might get hold of, and the therapeutic worth of TSC; the optimum doses and dosing regimens of TSC in reference to the potential therapy of any specific illness or indication; the Firm’s skill to design, provoke, enroll, execute, and full its ongoing and deliberate research evaluating TSC, together with Examine 200-208; the probability and timing of regulatory approval of TSC, if any, for the therapy of strong tumors sophisticated by hypoxia or every other indication, or the character of any suggestions the Firm might obtain from the FDA or different regulatory our bodies; the influence of world provide chain disruptions on the Firm’s drug product manufacturing capabilities, scientific improvement program, and related timelines;; the Firm’s skill to guard and develop its mental property portfolio; the provision of money sources; normal financial, political, enterprise, trade, and market situations, together with the continued COVID-19 pandemic, inflationary pressures, and geopolitical conflicts; and the opposite elements mentioned below the heading “Threat Components” within the Firm’s filings most up-to-date Annual Report on Kind 10-Ok, subsequent Quarterly Experiences on Kind 10-Q, and different filings with the U.S. Securities and Alternate Fee. Any forward-looking statements on this press launch converse solely as of the date hereof (or such earlier date as could also be recognized) and, besides as required by relevant regulation, rule, or regulation, the Firm undertakes no obligation to replace any such statements after the date hereof.
Contacts
Traders:
Tiberend Strategic Advisors, Inc.
Daniel Kontoh-Boateng/Jonathan Nugent
[email protected]
[email protected]
Steadiness Sheet
|
|
September 30, 2022 |
|
December 31, 2021 |
||||
|
Property |
|
|
|
||||
|
Present property: |
|
|
|
||||
|
Money and money equivalents |
$ |
6,587,018 |
|
|
$ |
37,313,558 |
|
|
Marketable securities |
|
19,270,940 |
|
|
|
— |
|
|
Pay as you go bills, deposits and different present property |
|
464,884 |
|
|
|
510,015 |
|
|
Whole present property |
|
26,322,842 |
|
|
|
37,823,573 |
|
|
Different property |
|
— |
|
|
|
15,578 |
|
|
Whole property |
$ |
26,322,842 |
|
|
$ |
37,839,151 |
|
|
Liabilities and Stockholders’ Fairness |
|
|
|
||||
|
Present liabilities: |
|
|
|
||||
|
Accounts payable |
$ |
807,372 |
|
|
$ |
947,495 |
|
|
Accrued bills and different present liabilities |
|
1,463,280 |
|
|
|
1,980,189 |
|
|
Whole present liabilities |
|
2,270,652 |
|
|
|
2,927,684 |
|
|
Stockholders’ Fairness: |
|
|
|
||||
|
Widespread inventory, $0.001 par worth: 1,000,000,000 shares licensed: 2,038,592 and a pair of,038,185 shares issued and excellent at September 30, 2022 and December 31, 2021, respectively |
|
2,039 |
|
|
|
2,038 |
|
|
Further paid-in capital |
|
165,657,681 |
|
|
|
164,914,540 |
|
|
Gathered different complete loss |
|
(86,955 |
) |
|
|
— |
|
|
Gathered deficit |
|
(141,520,575 |
) |
|
|
(130,005,111 |
) |
|
Whole stockholders’ fairness |
|
24,052,190 |
|
|
|
34,911,467 |
|
|
Whole liabilities and stockholders’ fairness |
$ |
26,322,842 |
|
|
$ |
37,839,151 |
|
|
|
|
|
|
||||
Assertion of Operations
|
|
Three Months Ended September 30, |
|
9 Months Ended September 30, |
||||||||||||
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
Working bills: |
|
|
|
|
|
|
|
||||||||
|
Analysis and improvement |
$ |
798,247 |
|
|
$ |
2,105,815 |
|
|
$ |
5,332,698 |
|
|
$ |
6,994,866 |
|
|
Intangible asset impairment cost |
|
– |
|
|
|
8,639,000 |
|
|
|
— |
|
|
|
8,639,000 |
|
|
Normal and administrative |
|
2,124,785 |
|
|
|
1,930,082 |
|
|
|
6,390,663 |
|
|
|
5,510,365 |
|
|
Depreciation |
|
– |
|
|
|
19,100 |
|
|
|
— |
|
|
|
67,302 |
|
|
Loss from operations |
|
2,923,032 |
|
|
|
12,693,997 |
|
|
|
11,723,361 |
|
|
|
21,211,533 |
|
|
Curiosity earnings |
|
(124,710 |
) |
|
|
(50,710 |
) |
|
|
(207,897 |
) |
|
|
(146,354 |
) |
|
Loss from operations earlier than earnings tax profit |
|
(2,798,322 |
) |
|
|
(12,643,287 |
) |
|
$ |
(11,515,464 |
) |
|
$ |
(21,065,179 |
) |
|
Earnings tax profit |
|
– |
|
|
|
(443,893 |
) |
|
|
– |
|
|
|
(443,893 |
) |
|
Internet loss |
$ |
(2,798,322 |
) |
|
$ |
(12,199,394 |
) |
|
$ |
(11,515,464 |
) |
|
$ |
(20,621,286 |
) |
|
Per share info: |
|
|
|
|
|
|
|
||||||||
|
Internet loss per share of widespread inventory, primary and diluted |
$ |
(1.37 |
) |
|
$ |
(5.99 |
) |
|
$ |
(5.65 |
) |
|
$ |
(10.76 |
) |
|
Weighted common shares excellent, primary and diluted |
|
2,039,089 |
|
|
|
2,037,978 |
|
|
|
2,038,716 |
|
|
|
1,916,107 |
|
|
Complete loss: |
|
|
|
|
|
|
|
||||||||
|
Internet loss |
$ |
(2,798,322 |
) |
|
$ |
(12,199,394 |
) |
|
$ |
(11,515,464 |
) |
|
$ |
(20,621,286 |
) |
|
Unrealized loss on marketable securities |
|
(372 |
) |
|
|
– |
|
|
|
(86,955 |
) |
|
|
– |
|
|
Complete loss: |
$ |
(2,798,694 |
) |
|
$ |
(12,199,394 |
) |
|
$ |
(11,602,419 |
) |
|
$ |
(20,621,286 |
) |
|
|
|
|
|
|
|
|
|
||||||||
