Based on:

   1. its cash position at June 30, 2022, 
 
   2. the current development plan of the Company including 1) the completion 
      of its ongoing Phase 2 NASH trial for PXL065 (DESTINY-1) but excluding 2) 
      the two identical Phase 2a clinical proof-of-concept (POC) biomarker 
      studies for PXL065 and PXL770 in adrenomyeloneuropathy $(AMN)$, 
 
   3. the cash forecast for the year 2022 approved by the Board of Directors of 
      the Company, that does not include, as a conservative approach, any net 
      royalties from Imeglimin in Japan, 
 
   4. a strict control of its operating expenses, and 
 
   5. the amendment to the IPF debt facility with the postponement of the Q3 
      2022 and Q4 2022 amortization payments until end of February 2023, as 
      well as a full drawdown of all tranches of the equity-linked financing 
      arrangement with IRIS for a total amount of EUR 6 million, before 
      December 31, 2022, 

the Company expects that its resources will be sufficient to fund its operations and capital expenditure requirements through at least February 2023.

The Company is actively pursuing additional financing options, prioritizing non-dilutive sources, including ongoing active partnership discussions related to its programs.

Second Quarter and First Half 2022 Revenue

Poxel reported revenues of EUR 83 thousand revenue for the six months ended June 30, 2022, as compared to EUR 13.3 million revenue during the corresponding period in 2021.

Revenue for the first half of 2022 reflects JPY 11 million (EUR 81 thousand) of royalty revenue from Sumitomo Pharma which represents 8% of TWYMEEG net sales in Japan. Based on the current forecast, Poxel expects to receive 8% royalties on TWYMEEG net sales in Japan through the Sumitomo Pharma fiscal year 2022 (April 2022 to March 2023). As part of the Merck Serono licensing agreement, Poxel will pay Merck Serono a fixed 8% royalty based on the net sales of Imeglimin, independent of the level of sales.

 
EUR (in             Q1      Q2      H1      Q1       Q2      H1 
thousands)         2022    2022    2022     2021    2021     2021 
                    3       3       6        3       3        6 
                  months  months  months  months   months  months 
---------------   ------  ------  ------  -------  ------  ------- 
Sumitomo Pharma 
 Agreement          32      51      83       -     13,274  13,274 
----------------  ------  ------  ------  -------  ------  ------- 
Other               -       -       -        - 
---------------   ------  ------  ------  -------  ------  ------- 
Total revenues      32      51      83       -     13,274  13,274 
----------------  ------  ------  ------  -------  ------  ------- 
Unaudited data 
 

Planned Presentations and Participation at the Following Upcoming Events

   -- Keystone Symposia, Whistler, British Columbia, Canada, August 7-11 
 
   -- Paris NASH Meeting, Paris, France, September 8-9 
 
   -- Eurotox, International Congress of Toxicology, Maastricht, Netherlands, 
      September 18-21 

Next Financial Press Release : First Half 2022 financial results on September 21, 2022

About Poxel SA

Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis $(NASH)$ and rare disorders. Poxel has clinical and earlier-stage programs from its adenosine monophosphate-activated protein kinase (AMPK) activator and deuterated thiazolidinedione $(TZD)$ platforms targeting chronic and rare metabolic diseases. For the treatment of NASH, PXL065 (deuterium-stabilized R-pioglitazone) is in a streamlined Phase 2 trial (DESTINY-1). PXL770, a first-in-class direct AMPK activator, has successfully completed a Phase 2a proof-of-concept trial for the treatment of NASH, which met its objectives. For the rare inherited metabolic disorder, adrenoleukodystrophy $(ALD.AU)$, the company intends to initiate Phase 2a proof of concept studies with PXL065 and PXL770 in patients with adrenomyeloneuropathy $(AMN.AU)$. TWYMEEG$(R)$ (Imeglimin), Poxel's first-in-class lead product that targets mitochondrial dysfunction, has been approved and launched for the treatment of type 2 diabetes in Japan. Poxel expects to receive royalties and sales-based payments from Sumitomo Pharma. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries. The Company intends to generate further growth through strategic partnerships and pipeline development. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.

For more information, please visit: www.poxelpharma.com

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, without limitation, any statements preceded by, followed by or including words such as "target," "believe," "expect," "aim," "intend, " "may," "anticipate," "estimate," "plan," "project," "will," "can have, " "likely," "should," "would," "could" and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. The Company does not endorse or is not otherwise responsible for the content of external hyperlinks referred to in this press release.

(1) For more information on Orphan Drug Designation, see: https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products

View source version on businesswire.com: https://www.businesswire.com/news/home/20220807005027/en/

 
    CONTACT: 

Contacts - Investor relations / Media

Aurélie Bozza

Investor Relations & Communication Senior Director

aurelie.bozza@poxelpharma.com

+33 6 99 81 08 36

Elizabeth Woo

Senior Vice President, Investor Relations & Communication

elizabeth.woo@poxelpharma.com

NewCap

Emmanuel Huynh or Arthur Rouillé

poxel@newcap.eu

+33 1 44 71 94 94

$(END)$ Dow Jones Newswires

August 08, 2022 01:00 ET (05:00 GMT)