ObsEva SA (OBSV)

[Pan_O_War]

Let's go!

[Frankestin]

I think now they will make it go up!
Go to 3

[Frankestin]

Feb. 01, 2022 (GLOBE NEWSWIRE) -- ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies for women’s health, today announced the appointment of Katja Buhrer as Chief Strategy Officer and member of the company’s Executive Committee, effective February 1, 2022. Ms. Buhrer will oversee a range of operational areas including corporate strategy, investor relations and public relations, and will contribute in other areas such as business development and alliance management.

“We are thrilled to welcome Katja to ObsEva at this important time in the company’s growth,” said Brian O’Callaghan, Chief Executive Officer of ObsEva. “Katja is an accomplished corporate development executive whose track record managing strategic transactions, partnerships, and investor relations programs strengthens our leadership team as we prepare to transition to a commercial-stage company. We further look forward to her leadership as we explore new indications, partnerships, and other strategic opportunities that enhance ObsEva’s value.”

Ms. Buhrer commented, “I am delighted to join ObsEva and collaborate with the executive team to address large, underserved indications that compromise women’s reproductive health. ObsEva’s regulatory, clinical, and strategic advances in the past year, coupled with upcoming catalysts as the company pursues multiple approvals in 2022, make this a compelling opportunity. I look forward to working towards real change in women’s health while enhancing value for our shareholders.”

[Pan_O_War]

Obseva: In January, the Geneva-based biotech company saw three share purchases by one or more board members totaling almost half a million Swiss francs. The remarkable thing is that these are the first share purchases by company executives since December 2020. Last Friday, four days after the last of the three purchases, Obseva announced a capital increase, which sent the stock plunging as much as 16 percent at times on Monday.

Obseva shares have lost nearly 60 percent of their value over the past year and are currently trading at record lows. The company, whose market value is still just under 100 million francs, is being traded as a takeover candidate. A commitment is only suitable for extremely risk-capable investors.

source cash.ch

[Pan_O_War]

XBI ETF is a massive current and gives an additional layer of context on the story of OBSV's price - outside of any issues/merits of the company itself.

[Pan_O_War]

Insider Buying 1.24.2022 + 50,000 Shares

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https://www.ser-ag.com/de/resources/notifications-market-participants/management-transactions.html?issuedBy=OBSEVA#/

[Pan_O_War]

Not sure if my below post is accurate - but cannot delete!

[Pan_O_War]

Looks like on the CHMP agenda for decision this week (w/o 1.24)

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https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-agenda-24-27-january-2022-meeting_en.pdf

[Pan_O_War]

Amplifying Scientific Innovation®: JPM22 Health Equity, Dr. Elizabeth Garner, CMO, ObsEva


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[FLY HIGH NOW]

https://finance.yahoo.com/news/obseva-announces-positive-topline-results-120000442.html

[Frankestin]

I was expecting some news for this:
Ebopiprant for Treatment of Preterm Labor: Preparations are ongoing to initiate a Phase 2b clinical study in Q4:21. The Phase 2b dose ranging study will build on the recently announced PROLONG Phase 2a proof-of-concept study, which demonstrated early clinical efficacy and safety in pregnant women with spontaneous preterm labor. Given ebopiprant is currently the only known product in development for this indication and based on its innovative mechanism of action and positive topline data, the Company plans to discuss with European regulators a possible accelerated registration program based on a Phase 2b/3 adaptive design. In parallel with development of ebopiprant in Europe and Asia, the Company is also actively evaluating the regulatory strategy for ebopiprant development in the United States, where there are currently no FDA-approved tocolytic medications available for treatment of preterm labor.

likely something changed after this:
https://www.organon.com/news/organon-and-obseva-enter-global-license-agreement-to-develop-and-commercialize-ebopiprant-obe022-an-investigational-agent-being-evaluated-as-a-first-in-class-treatment-for-preterm-labor/

[Pan_O_War]

Insider buying? (not sure whom):

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https://www.ser-ag.com/de/resources/notifications-market-participants/management-transactions.html?issuedBy=OBSEVA#/

[Pan_O_War]

$21.00 Price Target

[FLY HIGH NOW]

https://www.tipranks.com/experts/analysts/liana-moussatos

[Pan_O_War]

Endometriosis Drug Shows Promise in Preliminary Phase 3 Trial Results


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https://www.sciencealert.com/drug-company-announces-topline-results-for-endometriosis-pain-research

[Pan_O_War]

Heavily shorted atm w/about 5 days to cover. Perhaps this is what is suppressing the price?

[Pan_O_War]

NEW 2022 Corporate Presentation here:


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https://www.obseva.com/wp-content/uploads/2021/02/ObsEva_Corporate-Deck_Latest.pdf?doing_wp_cron=1641543229.7086830139160156250000

[Pan_O_War]

ObsEva Announces Positive Topline Results for Linzagolix 200 mg with Add-Back Therapy in the Phase 3 EDELWEISS 3 Trial in Patients with Moderate-to-Severe Endometriosis-Associated Pain

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https://www.obseva.com/pressrelease-detail/?pr=4786

[Frankestin]

https://www.obseva.com/pressrelease-detail/?pr=4786

Once daily linzagolix 200 mg with ABT met both co-primary efficacy objectives, demonstrating reductions in dysmenorrhea and non-menstrual pelvic pain versus placebo at 3 months; showed statistically significant and clinically meaningful improvements versus placebo in ranked secondary endpoints of dysmenorrhea, non-menstrual pelvic pain, dyschezia, overall pelvic pain, and ability to perform daily activities at 6 months-

Ongoing for up to an additional 6 months
https://clinicaltrials.gov/ct2/show/NCT04335591

Where will they decide to take it?

[Pan_O_War]

ObsEva to Present at the H.C. Wainwright BioConnect 2022 Conference

[url]https://www.globenewswire.com/news-release/2022/01/03/2359807/0/en/ObsEva-to-Present-at-the-H-C-Wainwright-BioConnect-2022-Conference.html
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https://www.globenewswire.com/news-release/2022/01/03/2359807/0/en/ObsEva-to-Present-at-the-H-C-Wainwright-BioConnect-2022-Conference.html

[Frankestin]

https://www.globenewswire.com/news-release/2022/01/03/2359807/0/en/ObsEva-to-Present-at-the-H-C-Wainwright-BioConnect-2022-Conference.html
Oh good!
They want appropriate showcase to comment on the data!
IMO

[Pan_O_War]

7 of the Best Penny Stocks Under $3 for 2022 to Buy Now (OBSV #1):

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https://investorplace.com/2021/12/7-of-the-best-penny-stocks-under-3-for-2022-to-buy-now/

[Pan_O_War]

Yeah - that's the last piece for this year!

[Frankestin]

Good!
waiting for
https://www.biospace.com/article/releases/obseva-announces-enrollment-completion-of-linzagolix-phase-3-edelweiss-3-trial-for-patients-with-moderate-to-severe-endometriosis-associated-pain-/
https://www.clinicaltrialsarena.com/comment/obseva-yselty-edelweiss-endpoint-data/
https://seekingalpha.com/news/3781226-obseva-on-track-for-european-approval-of-uterine-fibroids-therapy

[Pan_O_War]

ObsEva Added to the NASDAQ Biotechnology Index ObsEva SA

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https://www.stonkmoon.com/news/OBSV/02af91d89eee259cc5db807cb18e918d

[Pan_O_War]

Wedbush Reaffirms Their Buy Rating on ObsEva SA (OBSV) $21.00
[url]
https://www.analystratings.com/articles/wedbush-reaffirms-their-buy-rating-on-obseva-sa-obsv/[/url][tag]insert-text-here[/tag]

https://www.analystratings.com/articles/wedbush-reaffirms-their-buy-rating-on-obseva-sa-obsv/

[Pan_O_War]

[FLY HIGH NOW]

https://finance.yahoo.com/news/obseva-announces-positive-chmp-opinion-120000531.html


Very positive news for FDA approval and EU accepted

[Pan_O_War]

Looking good!

[Frankestin]

it's not over
Next in Q4:
Phase 3 Endometriosis results.

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.

[Frankestin]

the strong results on the full suppression dose (200 mg) with ABT showed that linzagolix could potentially offer best-in-class efficacy.”
A final marketing authorization decision from the EC is anticipated within two months. The CHMP’s positive opinion follows the recent FDA acceptance for review of the uterine fibroids New Drug Application (NDA) (PDUFA date of September 13, 2022).

[Frankestin]

ObsEva Announces Positive CHMP Opinion for Linzagolix, an Oral GnRH Antagonist, for the Treatment of Uterine Fibroids

-European Commission Decision Anticipated in Q1 2022-

-CHMP recommendation follows the recent acceptance of the linzagolix uterine fibroids NDA by the U.S. Food and Drug Administration-

[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