ObsEva SA (OBSV)

[FLY HIGH NOW]

https://www.yahoo.com/finance/news/pfizer-pfe-gets-approval-eczema-155403362.html

Obsv will Soon to Be Approved in EU

[Pan_O_War]

ObsEva Appoints Will Brown as Chief Financial Officer

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https://www.obseva.com/pressrelease-detail/?pr=4750

[Pan_O_War]

ObsEva Hosts Symposium and Presents Clinical Data on Oral GnRH Antagonist Linzagolix at SEUD Congress 2021

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https://www.obseva.com/pressrelease-detail/?pr=4744&doing_wp_cron=1639135873.3893389701843261718750

[FLY HIGH NOW]

https://finance.yahoo.com/news/obseva-shares-jump-linzagolix-application-115549570.html

[Pan_O_War]

ObsEva Announces Symposium and Presentation of Clinical Data on Oral GnRH Antagonist Linzagolix at SEUD Congress 2021: Dec 10th

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https://www.obseva.com/pressrelease-detail/?pr=4739

[Frankestin]

It takes something strong to project it out!
I think that if from October 2021 the balls are tied, they will have done it with good reason ... but maybe I'm wrong

[Frankestin]

In October 2021, we entered into a convertible note financing agreement, or the Note Agreement, with certain funds and accounts managed by JGB Management, Inc., or JGB, which is structured to provide up to $135 million in borrowing capacity, available in nine tranches. The last four tranches may be drawn at the Company’s option. The availability of each of the nine tranches will be subject to the Company meeting certain conditions, including, among others, that the Company’s volume-weighted average price is not below $3.00 per share for five or more trading days during the 30 days prior to a tranche funding date. The second tranche will be funded 135 days following the initial closing and each subsequent tranche will be funded 90 days after the preceding tranche. The Company’s overall leverage and certain covenants and obligations contained in the related documentation could adversely affect its financial health and business and future operations by, among other things:

•making it more difficult to satisfy its obligations, including under the terms of the Note Agreement;

•limiting its ability to refinance its debt on terms acceptable to the Company or at all;
•limiting its flexibility to plan for and adjust to changing business and market conditions and increasing its vulnerability to general adverse economic and industry conditions;
•limiting its ability to use our available cash flow to fund future acquisitions and to make dividend payments; and
•limiting its ability to obtain additional financing for working capital, to fund growth or for general corporate purposes, even when necessary to maintain adequate liquidity.

In addition, the Note Agreement is secured by an account control agreement in favor of JGB, and the Company is obligated to maintain a minimum cash amount of $25 million in such deposit account, subject to additional incremental increases totaling $27.0 million in aggregate depending on the amount of debt outstanding under the Note Agreement. The Company’s obligations under the Notes are guaranteed by all of the Company’s subsidiaries pursuant to a corporate guaranty agreement entered into in connection with the Note Agreement. Upon the occurrence and during the continuance of an event of default, JGB may declare all outstanding principal and accrued and unpaid interest under the notes immediately due and payable and exercise the other rights and remedies provided for under the notes, the Note Agreement and related loan documents.

We have not generated any revenues, have a history of losses and expect to incur substantial future losses. Our recurring losses, negative cash flows and significant accumulated deficit have raised substantial doubt regarding our ability to continue as a going concern. If we are unable to obtain additional capital, we may not be able to continue our operations on the scope or scale as currently conducted, and that could have a material adverse effect on our business, results of operations and financial condition.

Since inception, we have experienced recurring operating losses and negative cash flows from operating activities, and have significant accumulated deficit. We expect to continue to generate operating losses for the foreseeable future. As of September 30, 2021, we had cash and cash equivalents of $62.9 million and subsequent to September 30, 2021, we received additional proceeds as part of the convertible note financing agreement (the “Note Agreement”) we entered into with certain funds and accounts managed by JGB Management, Inc. The Note Agreement is structured to provide $135 million in borrowing capacity, available in nine tranches, with the first tranche being funded at the initial closing in October 2021. The subsequent tranches under the Note Agreement will be available subject to us meeting certain conditions, including, among others, that our volume-weighted average price is not below $3.00

[Frankestin]

Let 's hope that the opinion is negative otherwise we go to zero!

[Pan_O_War]

Obseva Announces Appointment of Stephanie Brown to its Board of Directors, "Ms. Brown brings valuable commercial expertise and industry insight to the Company."

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https://www.obseva.com/pressrelease-detail/?pr=4721

[Pan_O_War]

"...with an approval recommendation from the Committee for Medicinal Products for Human Use (CHMP) expected in Q4 2021."

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https://www.obseva.com/pressrelease-detail/?pr=4718

[Pan_O_War]

Thank you.

[Pan_O_War]

Obseva Announces U.S. FDA Acceptance of New Drug Application for Linzagolix

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https://www.obseva.com/pressrelease-detail/?pr=4718

[Frankestin]

December 13, 14, 15, 16
https://www.ema.europa.eu/en/documents/other/chmp-meeting-dates-2021-2022-2023-2024_en.pdf

[Frankestin]

OBSEVA ANNOUNCES U.S. FDA ACCEPTANCE OF NEW DRUG APPLICATION FOR LINZAGOLIX
FDA SET A TARGET ACTION DATE OF SEPTEMBER 13, 2022 FOR THIS NDA UNDER PRESCRIPTION DRUG USER FEE ACT (PDUFA)
LINZAGOLIX MARKETING AUTHORIZATION APPLICATION WAS VALIDATED BY EMA FOR HUMAN USE (CHMP) EXPECTED IN Q4 2021

[Pan_O_War]

ObsEva Announces Third Quarter 2021 Financial Results and Business Update

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https://www.obseva.com/pressrelease-detail/?pr=4708

[Frankestin]

https://www.fertstert.org/article/S0015-0282(21)01480-1/pdf
https://www.fertstert.org/article/S0015-0282(21)01452-7/pdf

[GolfFishSurf]

Exactly.

[Theo]

"Repost [Pivot to Valuation] Many here are wondering why the stock price has not appreciated significantly yet. The Company does not generate revenue yet, and its lead product, pipeline have yet to be approved anywhere in the world. The real valuation will come in phases (IMO) - Linzagolix approval in MAA, approval in US (FDA) - followed by first revenue-generating contract(s) on the product. Subsequent approval on Linzagolix (Endometriosis) and/or Ebopiprant will generate sizeable, incremental value here. Major catalysts are coming here in Q4, which setup a strong 2022 potentially for OBSV (IMO).
© 2021 InvestorsHub.com, Inc. "

Precisely and is why I sold out 2-3 months ago- #msg-165137134 & especially this post #msg-165145133

I still believe there is money to be made here...just not now. {Major catalysts are coming here in Q4, which setup a strong 2022 potentially for OBSV}- My hope was that approval/revenue would start earlier than later. My biggest fear was, and has ALWAYS been, that if they didn't start producing revenue "soon", they would need to raise more cash- something I see happening shortly. I would rather wait to see when and how much they dilute before taking back a position.

I still keep my eye on this

[Pan_O_War]

Repost [Pivot to Valuation] Many here are wondering why the stock price has not appreciated significantly yet. The Company does not generate revenue yet, and its lead product, pipeline have yet to be approved anywhere in the world. The real valuation will come in phases (IMO) - Linzagolix approval in MAA, approval in US (FDA) - followed by first revenue-generating contract(s) on the product. Subsequent approval on Linzagolix (Endometriosis) and/or Ebopiprant will generate sizeable, incremental value here. Major catalysts are coming here in Q4, which setup a strong 2022 potentially for OBSV (IMO).

[Frankestin]

Linzagolix is the only GnRH antagonist to provide flexible dosing options to better address the individual needs of patients, and these results further underscore its differentiated profile and potential clinical utility.

the market is still cold

[Pan_O_War]

ObsEva Presents Clinical Data on Oral GnRH Antagonist Linzagolix for the Treatment of Uterine Fibroids at ASRM 2021 Scientific Congress & Expo

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https://www.obseva.com/pressrelease-detail/?pr=4684

[Pan_O_War]

ObsEva Announces Presentation of Clinical Data on Oral GnRH Antagonist Linzagolix at ASRM 2021 Scientific Congress & Expo (on 10.20.21)

[url]https://www.obseva.com/pressrelease-detail/?pr=4681&doing_wp_cron=1634637856.9923601150512695312500
[/url][tag]insert-text-here[/tag]

https://www.obseva.com/pressrelease-detail/?pr=4681&doing_wp_cron=1634637856.9923601150512695312500

[Frankestin]

https://www.globenewswire.com/news-release/2021/10/19/2316113/0/en/ObsEva-Announces-Presentation-of-Clinical-Data-on-Oral-GnRH-Antagonist-Linzagolix-at-ASRM-2021-Scientific-Congress-Expo.html

[Pan_O_War]

Repost: Look at the progression over the last quarter. The Company files for Linzagolix regulatory approval in the EU and US (Sept-2021) respectively following strong phase-III data including longitudinal performance, they hire/appoint a CTO in-part to shepherd Linzagolix (see URL below), should it receive regulatory approval. They then sign an agreement with Syneos Health to broadly commercialize their product, renegotiate the terms of Linzagolix with Kissei, secure additional capital through JGB with warrants convertible at $3.65 strike price. This is all being accomplished ahead of MAA (Q4-2021) and FDA (Q1-2022E) evaluation of the lead product, while the same drug is being studied concurrently (phase-III) to help those suffering from Endometriosis (Ph-III primary endpoint, Q4-2021) and an additional drug (Ebopiprant) is progressing through Phs-2 to address/mitigate pre-term labor.

[Pan_O_War]

Repost: From a financial perspective, the Company has a relatively good cash runway (Current Ratio: 4, Cash Ratio: 3) with limited debt obligations. That said-the Company burn rate is rather high with no revenue yet on its product lines. The hope/expectation here is that Linzagolix will receive approval both in EU and US, respectively (uterine fibroids) to lead a strong product pipeline through 2022. The Company was able to sign an agreement with Syneos Health to broadly commercialize their product, established a
$135MILS

borrowing agreement with JGB Management to retire current debt and fund future programs. Notes paid in stock at $3.20 price and Warrants with $3.65 strike. They also negotiated more favorable terms on sales milestones and royalty payments to Kissei on Linzagolix. The Company is positioning itself for US and/or EU approval upcoming, and the broad commercialization of their front-running product. Federal (US/EU) approval of Linzagolix will send this stock IMO.

[Pan_O_War]

Repost: This is a solid PR (IMO), as OBSV is positioning itself for broad commercialization of Linzagolix upon US and/or EU approval (both currently under review). The Company was able to sign an agreement with Syneos Health to broadly commercialize their product, established a
$135MILS
borrowing agreement with JGB Management to retire current debt and fund future programs. Notes paid in stock at $3.20 price and Warrants with $3.65 strike. They also negotiated more favorable terms on sales milestones and royalty payments to Kissei on Linzagolix. The Company is positioning itself for US and/or EU approval upcoming, and the broad commercialization of their front-running product. I added today and continue to do so in earnest at/under $2.85. Federal (US/EU) approval of Linzagolix will send this stock IMO.

[Pan_O_War]

(MUST READ from another Board): Today we got a 3 in one press release with all 3 news bits being major. Let's break them down one by one:

1. Agreement with Kissei. Background: the product Obseva is set to receive authorization for in the EU and US was essentially bought by Obseva from Kissei. Obseva needs to pay Kiseei royalties for sales plus set values when reaching certain milestones. It also needs to buy the raw materials so to speak, to produce the drug, from Kissei. In this amendment, some changes where made: apparently Obseva is receiving a longer period of time by which to measure certain milestones. This will enable Obseva to spread those payments and ease any financial obligations. That is a positive.
Another change: instead of paying royalties of over 20% for sales, which include (in that number) the buying of raw material from Kissei (which was a bit of a messed up agreement to begin with), Obseva now will only pay royalties in single digits (so under 10%, which is standard in the market) and separately, pay for product. Makes more sense and apparently at least, reduces costs for Obseva.

2. The 1st bit of news is totally related to this 2nd bit of news, because all these are related and therefore release as a single press release. To me, it seems evident Obseva re-negotiated a better agreement with Kissei because it entered a commercialization agreement with Syneos, which is by far the most important part of this press release. Syneos is huge and can place the product literally anywhere in the world. This is really big news and in a normal world, it should spike the stock price today. Obseva set itself up very nicely with this agreement and is ready to launch itself into being a commercial stage pharma.

3. Of course, it's easier to negotiate debt when you have a partner the size of Syneos backing your commercial launch, and can also show an improved agreement with Kissei. In that sense, the agreement with JGB is excellent. Of course, it's never great when the company is letting us know it borrowed money. But within that context, the deal is interesting and smart.
Obseva is essentially borrowing money from an investment fund and paying it with its own stock. It's a cheaper solution than conventional borrowing and also is a bet by funds that Obseva is a solid investment. It clears Obseva from some conventional debt it had, which helps.

All this is being released October 13th. Which gives me hope that, after all, I am right in calculating that tomorrow, October 14th, might be the approval date for the CHMP. It makes a lot of sense to release this news the day before the CHMP and here is hoping the positive opinion is delivered tomorrow.

One way or another, good work by Obseva setting themselves up to start selling and creating revenue.

[Pan_O_War]

ObsEva Announces Relationship with Syneos Health to Commercialize Linzagolix

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https://www.obseva.com/pressrelease-detail/?pr=4677

[Pan_O_War]

Q4-2021 should be strong for OBSV, as the Linzagolix (uterine fibroids) NDA is now under consideration in the US while the MAA recommendation on the same is expected this quarter. MAA approval would be strong for the EU and US, as the US would be more inclined (IMO) then to approve. The Edelweiss Phase-III primary endpoint is also scheduled for Q4-2021, not to mention the other products in the Company pipeline (shown here). All test results that I have seen to this point have been promising - the Linzagolix NDA includes 52-week treatment results from the Phase 3 PRIMROSE 1 (the U.S. only; n=574) and PRIMROSE 2 (Europe and U.S.; n=535) clinical studies as supportive results from the 76-week post-treatment follow-up study.
[url]
https://www.obseva.com/our-pipeline-overview/?doing_wp_cron=1634004122.4332900047302246093750[/url][tag]insert-text-here[/tag]

https://www.obseva.com/our-pipeline-overview/?doing_wp_cron=1634004122.4332900047302246093750

[Pan_O_War]

After an extended period of sideways movement, a breakout seems likely as the positive news flow continues.

https://marketwirenews.com/news-releases/7-hot-penny-stocks-to-buy-in-q4-for-10-bagger-potent-6247052402718799.html

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[Pan_O_War]

Thank you.

[Frankestin]

https://www.ema.europa.eu/en/documents/other/chmp-meeting-dates-2021-2022-2023-2024_en.pdf

[Pan_O_War]

Thank you.

[Frankestin]

Ebopiprant for treatment of preterm labor: Phase 2b dose ranging study initiation in EU/Asia (Q4:21)

Company plans to discuss with European regulators a possible accelerated registration program based on a Phase 2b/3 adaptive design.

[Pan_O_War]

Q4 starts today - which means this is the quarter where we get:
- FDA Accepts the NDA Submission (not the same as approval)
- the Yselty CHMP opinion (European)
- Phase 3 Endometriosis results.

[Pan_O_War]

ObsEva Announces Appointment of Luigi Marro as Chief Transformation Officer.

Mr. Marro added, “I am excited to be joining ObsEva at this critical juncture and look forward to working with the outstanding team to drive successful transformation outcomes as we prepare linzagolix for market launch in uterine fibroids, if approved."

https://www.obseva.com/pressrelease-detail/?pr=4668

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[Pan_O_War]

The product portfolio here is solid with multiple catalysts in the next 6-12mos.

Linzagolix has the lead here under PRIMROSE (Uterine Fibroids). NDA just submitted (US) and MAA (EU) opinion upcoming in Q4-2021.

All of the data including longitudinal have been solid on this product/application, which improves the likelihood here of approval.

Linzagolix is also in Phs-3 for Endometriosis (Edelweiss), the first data point for which is also scheduled for Q4-2021.

Ebopiprant (pre-term labor) has been licensed globally to Organon (Phase-2B) and is proceeding well through studies.

[Pan_O_War]

Bull Flag Breakout:

[Pan_O_War]

End of Year Catalysts:

Q4 European Marketing Approval

Q4 Endometriosis Phase III Data readout

+60 days from 9.15 Submission: FDA accepts review of NDA Submission

[Pan_O_War]

ObsEva Announces Submission of New Drug Application to U.S. FDA for Linzagolix for the Treatment of Uterine Fibroids

https://www.obseva.com/pressrelease-detail/?pr=4561


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[Frankestin]

The NDA submission is a major milestone in making linzagolix available in the U.S., and an important step toward addressing the diverse medical needs that exist for women with uterine fibroids,” said Brian O’Callaghan, CEO of ObsEva. “Our positive Phase 3 PRIMROSE results underscore linzagolix’s clinical utility and well-known differentiated profile. If approved, linzagolix will be the first oral GnRH antagonist to offer treatment options for women who cannot or do not want to take hormones, as well as for women who are able to take additional hormone therapy. We look forward to overcoming existing challenges in the treatment of uterine fibroids -- with linzagolix’s unique low-dose option (100 mg without ABT) and high dose option (200 mg with ABT) -- and will work with the FDA through the regulatory process as we prepare for commercialization.”

Concurrently, ObsEva is also working closely with the European Medicine Agency’s (EMA) to achieve marketing approval. Linzagolix previously received validation of the marketing authorization application (MAA) with an approval recommendation from the Committee for Medicinal Products for Human Use (CHMP) expected in Q4 2021.

[Pan_O_War]

This morning at the H.C. Wainwright conference, Obseva team:
- confirmed the potential best in class profile of Linzagolix
- mentioned 50% of US women suffering from uterine fibroids may have a contraindication to hormonal ABT
- confirmed that the NDA submission for Linzagolix will occur this quarter (as planned)

[Frankestin]

https://journey.ct.events/view/32784fc4-edc6-47a1-b2d5-93cb101bd79f
wait and wait!
18 days maximum!

[Frankestin]

https://pipelinereview.com/index.php/2021011177126/Small-Molecules/European-Medicines-Agency-Validates-Yselty-MAA-for-Uterine-Fibroids-US-NDA-Planned-for-1H-2021.html
old but explains upcoming events

[Pan_O_War]

ObsEva to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

https://www.obseva.com/pressrelease-detail/?pr=4564

https://www.obseva.com/pressrelease-detail/?pr=4564

[Pan_O_War]

[Pan_O_War]

This should be THE month for the NDA Submission!

[Frankestin]

Come on! At most another 30 days!
OHMMMM

[Frankestin]

From second it became third!
Inspector Callaghan does not postpone again

[Pan_O_War]

New Investor Presentation:

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https://www.obseva.com/wp-content/uploads/2021/02/ObsEva_Corporate-Deck_Latest-1.pdf