
Wednesday, July 02, 2025 9:18:01 PM
If this may console you, I did sent a letter/email yesterday evening to UNCY. inquiring specifically on 2 separate matters: 1- the streamlining of all R& D and G& A overhead expenses over the year.
2- I also inquired about the manufacturer’s CMC issues & whether they are contemplating expanding to the list of the 3 manufacturer's disclosed ion their statement in order to avoid having to pay premium cost to the selected final manufacturers which would affect their COG & their gross profit margin.
I just did receive a quick response as of this afternoon via email with the following verbatum response:
" Kevin Gardner <kgardner@lifesciadvisors.com>
1:06?PM (5 hours ago)
to me, IR
Dear Mr. Kuziora,
Thank you for your thoughtful outreach.
I have relayed your message to Unicycive management, and they appreciate your inquiry.
I’m somewhat constrained on details that may not yet be public.
However, I can tell you that the management team is highly confident that a resolution with the FDA will be resolved in an expeditious manner, while bringing the cash burn down to a minimal level.
They made a commitment to be prudent about adding commercial hires until they have an approval in hand.
The company will report more details on cash level and burn on the 2Q’25 earnings release, which will be coming this summer.
They will also communicate more details on the anticipated Type A meeting with the FDA when appropriate in the coming days.
Thank you again, and please be assured this team remains incredibly excited about the market opportunity for OLC.
Best regards,
Kevin"
So apparently they are planning on reducing the bleeding of the cash burn & I also requested that they communicate my letter to the CEO & CFO of the company.
Here is the detail of my letter regarding the second issue:
2. With reference to the manufacturer’s CMC issues, you have disclosed the presence of a second manufacturer which has already successfully produced OLC drug as well as a backup third party. Are you actively eyeing for another possible manufacturer to avoid a possible situation where the designated manufacturer demands premium prices to produce the drug, thereby affecting your COG and margin profit
and avoid further delays in bringing the drug to market?
Recent UNCY News
- Form 8-K - Current report • Edgar (US Regulatory) • 06/30/2025 01:25:36 PM
- Unicycive Shares Sink After FDA Issues Response Letter on Kidney Drug Filing • IH Market News • 06/30/2025 12:56:54 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/20/2025 08:10:47 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 06/13/2025 08:21:51 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/10/2025 01:29:20 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 06/09/2025 02:40:44 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/09/2025 02:38:59 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/14/2025 12:01:50 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/14/2025 11:05:54 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/07/2025 08:21:05 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 04/30/2025 08:12:03 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 04/30/2025 08:06:41 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 04/18/2025 06:49:55 PM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 04/14/2025 08:30:35 PM
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