Seres Therapeutics Inc (MCRB)

[TheFinalCD]

NOW THATS A PROPER REGISTERED SHELF OFFERING

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173589378

[subslover]

Yeah,just like many others

[TheFinalCD]

RED ALERT))))) DILUTION TURD

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173589378&txt2find=mcrb

SOMETIMES DD MATTERS

:/

[subslover]

NEWS
Seres Therapeutics Announces VOWST™ Commercial Launch Update and US FDA Fast Track Designation for SER-155
VOWST preliminary net sales of approximately $10.4 million (unaudited) for the fourth quarter of 2023

Significant adoption of VOWST since commercial launch in June 2023 through year-end 2023 with 2,833 patient enrollment forms received and 2,015 new patient starts

SER-155 Phase 1b placebo-controlled Cohort 2 data readout anticipated in third quarter of 2024

Seres to Present at 42nd Annual J.P. Morgan Healthcare Conference on January 10, 2024

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced preliminary key VOWST (fecal microbiota spores, live-brpk) launch metrics and receipt of US FDA Fast Track Designation for SER-155 ahead of its presentation at the 42nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 10th. VOWST, the first FDA approved orally administered microbiome therapeutic, received FDA approval in April of 2023 and is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). VOWST is being commercialized by Nestlé Health Science in collaboration with Seres. SER-155 builds upon the clinical success of VOWST and is an investigational oral, cultivated microbiome therapeutic designed to prevent GI-associated bacterial infections, including blood stream infections, and to reduce the incidence of severe acute graft-versus-host disease (GvHD) in immunocompromised patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

“In 2023, VOWST received FDA approval with a broad indication, which includes use in first recurrence patients. We are thrilled, along with our collaborators at Nestlé Health Science, to help patients exit the vicious cycle of recurrence that happens far too often with CDI,” said Eric Shaff, President and Chief Executive Officer at Seres. “The strong adoption of VOWST since launch is indicative of the high unmet need in this category, the highly compelling clinical profile of VOWST, and the early success we have demonstrated in educating healthcare providers, payers and patients about this new treatment option.”

“Seres is looking forward to 2024 as we continue to build on our initial VOWST commercial success. The SER-155 Cohort-2 readout is expected in the third quarter, and we are excited to announce receipt of Fast Track Designation for SER-155 to reduce the risk of infection and GvHD in allo-HSCT patients. Fast Track Designation is awarded to expedite both drug development and FDA review of drugs to treat serious conditions and fulfill an unmet medical need.”

“I’m pleased with the significant progress made on our launch priorities since the commercial availability of VOWST in June,” said Terri Young, Ph.D., Chief Commercial and Strategy Officer at Seres. “Healthcare provider education efforts have scaled creating a positive customer experience with faster and higher conversion of enrollments to new patient starts. We look forward to continuing our efforts in 2024 with Nestlé Health Science and expect to make significant progress increasing the adoption of VOWST and achieving additional payer coverage.”

Seres will present at the 42nd annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2024, at 12:45 pm ET / 9:45 am PT. The live presentation and archived webcast will be accessible from the company’s website at www.serestherapeutics.com.

VOWST Commercial Performance

Broad demand for VOWST has been observed across rCDI patients and healthcare providers since product launch in June 2023:

Fourth quarter net sales were approximately $10.4 million (unaudited) and reflected a gross-to-net reduction of 11%. Total 2023 net sales since launch in June were approximately $19.6 million (unaudited) and reflected a gross-to-net reduction of 13%.
Fourth quarter completed prescription enrollment forms received for VOWST were 1,322; of those 1,082 resulted in new patient starts by year-end 2023.
Total 2023 completed prescription enrollment forms received for VOWST since launch were 2,833; of those 2,015 resulted in new patient starts by year-end 2023.
In 2023, prescription enrollment forms were submitted by approximately 1,330 unique healthcare providers (HCPs) since launch; approximately 340 HCPs have prescribed VOWST to more than one patient.
Seres 2023 Highlights

VOWST received FDA approval in April as the first and only FDA approved orally administered microbiome therapeutic to prevent recurrence of CDI in patients with rCDI, after treatment with standard of care antibacterials.
Strong adoption of VOWST since commercial launch in June 2023 with broad utilization, continued quarter over quarter growth, and significant progress achieving patient access.
Production of VOWST commercial supply enabled a strong commercial launch within weeks of approval; progress in expansion of VOWST manufacturing capacity.
SER-155 Phase 1b Cohort 1 clinical data showed favorable tolerability, successful drug bacteria engraftment, and a substantial reduction in pathogen domination in the gastrointestinal microbiome supporting progression to the placebo-controlled Cohort 2.
SER-155 received US FDA Fast Track Designation.
Completed strategic restructuring of Company to focus resources and investment on continued VOWST growth, completion of SER-155 Phase 1b study and supporting longer-term business sustainability.
Named to “TIME 100 Most Influential Companies” list of 100 companies making an extraordinary impact around the world.
Anticipated 2024 Milestones

Expect continued progress in 2024 towards commercial priorities including: Expansion of the number of HCPs prescribing VOWST as a result of new efforts scaled in Q4 2023 such as strengthened promotional campaigns and expanded reach of HCP and patient digital promotion. Growth of VOWST utilization earlier in the treatment paradigm including in patients experiencing their first recurrence. Maintenance of strong patient access and expansion of payer coverage for VOWST across Commercial and Medicare Part D plans. Increasing penetration of the hospital outflow patient segment.
SER-155 Phase 1b placebo-controlled Cohort 2 data readout anticipated in third quarter of 2024.
Seres ended 2023 with preliminary cash, cash equivalents and investments of approximately $128 million (unaudited). Seres anticipates that this year-end cash balance, in conjunction with the anticipated savings from the restructuring announced in November 2023 and the expected receipt of the $45 million Tranche B under its existing senior secured debt facility (the Term Loan Facility) with Oaktree Capital Management, L.P. (Oaktree), will support its operations into the fourth quarter of 2024.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR VOWST

INDICATION

VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI.

Limitation of Use: VOWST is not indicated for treatment of CDI.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Transmissible infectious agents: Because VOWST is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. Report any infection that is suspected to have been transmitted by VOWST to Aimmune Therapeutics, Inc. at 1-833-246-2566.

Potential presence of food allergens: VOWST may contain food allergens. The potential to cause adverse reactions due to food allergens is unknown.

ADVERSE REACTIONS

The most common adverse reactions (reported in ≥5% of participants) were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%), and diarrhea (10.0%).

To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics at 1-833-AIM-2KNO (1-833-246-2566), or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch.

DRUG INTERACTIONS

Do not administer antibacterials concurrently with VOWST.

Please see Full Prescribing Information and Patient Information

About Seres Therapeutics

Seres Therapeutics, Inc. (Nasdaq: MCRB) is a commercial-stage company developing novel microbiome therapeutics for serious diseases. Seres’ lead program, VOWST™, obtained U.S. FDA approval in April 2023 as the first orally administered microbiome therapeutic to prevent recurrence of C. difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI and is being commercialized in collaboration with Nestlé Health Science. Seres is evaluating SER-155 in a Phase 1b study in patients receiving allogeneic hematopoietic stem cell transplantation. For more information, please visit www.serestherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including the commercial success and continued growth of VOWST, the timing and results of our clinical studies, access to additional debt tranches, the sufficiency of cash to fund operations, and other statements which are not historical fact.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; our novel approach to therapeutic intervention; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product or product candidates and develop and commercialize our product or product candidates, if approved; the unknown degree and competing factors of market acceptance for VOWST; the competition we will face; our ability to protect our intellectual property; and our ability to retain key personnel and to manage our growth. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC), on November 2, 2023, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our

[TheFinalCD]

August 2023 Shelf
EDGAR
Registered

Current Raisable Amount
$300,000,000
https://dilutiontracker.com/app/search/MCRB

[REAGAN]

My pov of buying ($30/70k) is different than yours. I bought Thursday, Friday and today and will buy if it pops.

[REAGAN]

100% over 90 day volume as of 12:54

Something is up

[MiamiGent]

Pheww.. you're right!

I'll have to look and see what happened. That I wrote it then means I believed it then. But the charts don't lie.

[Extremist223]

You will miss all opportunity outside these dates???

My buying occurs between 12/15/23-1/10/24

[REAGAN]

Tax loss selling has not even started. My buying occurs between 12/15/23-1/10/24. The dumping is legendary. 88% institutional. On my radar.

[Extremist223]

BRO WHERE IS EVERYONE?!!?!!

[REAGAN]

Ooooofffff. This didn’t age well.

[REAGAN]

Nestle or similar.

[Extremist223]

No one got C. diff this year or what bahaha

[Extremist223]

wow you fell off a cliff and about to be non-compliant with nasdaq, like SINT, FAZE, and NEGG. hahaha

[Monksdream]

MCRB new 52 week low

[adamp]

This has to be the most incompetent pharma companies on the planet. actually worth less with a novel drug approved to market and selling. Goldman Sachs calling for a 'sell'. tipranks with the lowest score ever, a 1. this management is horrible. i hope to god there is a buyout in the works before seres leadership bankrupts this company

[adamp]

would love to hear any thoughts as to why this can't seem to get any positive attention even after FDA approval. They haven't filed the $125M from Nestle yet, I'm wondering if they're in discussions for buyout.

[adamp]

Ok, what's the word on the street here? Is Nestle going to buy Seres out or what? Either way, the PPS does not reflect the projected $750M/year of annual sales of this recently FDA approved drug. Some are saying the price is being held back for options to expire worthless on the 17th (this coming wednesday). Not sure what to make of all this except that it is following the same pattern as PRVB before buyout and the PRVB drug is not near as efficacious for DM as Seres' drug is for c diff.

[MiamiGent]

MCRB Perverse mkt action now. Candidate passed PDUFA and has great mkt potential. Rollout in June.
MCRB is partners with Nestle and many looking to an outright buyout.
Another candidate coming up in May.
I will hold and wait for eventual payday.

[MiamiGent]

ARNA did that in the past- an offering just before its big (successful) events.(ADCOM, PDUFA)

[Cosa]

Why would they use debt financing rather than do a share offering? They should have 8k a share offering months ago and then let it run and sell shares into the run. Approval was not guaranteed but at least position the company to take advantage of it.

[MiamiGent]

MCRB Another comment from another forum


killbilltrader
19m

$MCRB Buying all day with both hands. Derisked, partnership, royalties well positioned for growth.
Bullish

[MiamiGent]

.

[MiamiGent]

.

[MiamiGent]

MCRB Reprinted from another forum

CO145

$MCRB At the current price of $5.90/shr, this is trading at $565M market cap net of cash. pretty silly for a drug with a $1b US potential and $2B global potential plus a solid pipeline. The market cap will triple

[MiamiGent]

MCRB Good morning all.
Sold 20% @ high of AH session (7.00)
Just rebot more @ 6.04

[MiamiGent]

MCRB We are #2 Trending, after META.
Ours is a low price bio, catnip for the "boys" in the morning.
Hold on. We are going go higher tomorrow.

[MiamiGent]

$MCRB Seres Therapeutics Inc

Closed today @ $6.40 +$0.24 (3.90%)

After Hours snapshot (up another .47)

Bid ARCX 6.85 x 5 Ask ARCX 6.87 x 29
Volume 6,027,253

Seres Therapeutics, Inc. engages in the development of biological drugs through microbiome therapeutics platform. Its product pipeline includes SER-109, SER-287, SER-301, and SER-401. The company was founded by Geoffrey von Maltzahn, David A. Berry, and Noubar B. Afeyan on October 18, 2010 and is headquartered in Cambridge, MA.

[MiamiGent]

MCRB I think we'll see some lift tomorrow.
The likelihood of a buyout from Nestle is very good. Could come soon.
Not a bad stock to hang in with. Another in the pipeline coming up.

GL Cosa!

[MiamiGent]

US FDA approves Seres Therapeutics' pill for deadly C. difficile infections
REUTERS

https://stockcharts.com/h-sc/ui?s=MCRB

April 26 (Reuters) - The U.S. health regulator on Wednesday approved Seres Therapeutics Inc's (MCRB) pill for treating a type of bacterial infection, giving an easier and standardized option to patients who often have to rely on individual donors for fecal transplants. (Reporting by Raghav Mahobe and Aditya Samal in Bengaluru; Editing by Shinjini Ganguli)

[Cosa]

I though it would have a greater immediate impact on SP.

[MiamiGent]

MCRB Ok, news out. It passed!

No action yet but here is my post on ST


MiamiGent
2m

$MCRB It will slowly and gradually rise here in AH.
Wait for tomorrow. News will be out. The "boys" will latch on to this low PPS issue with good news. Tomorrow.
Bullish

[MiamiGent]

MCRB Quote
AS OF 4/26/2023 3:09PM ET
$6.45 +$0.29 (+4.71%)
Volume
4,351,333

https://stockcharts.com/h-sc/ui?s=MCRB

Still waiting for FDA announcement. I was in one not so long ago that came at 11 PM. I'm too old to remember what that stock symbol was, lol

[MiamiGent]

MCRB PDUFA today

Decision announced any time during day- probably after hours. Even very late in the evening

Company Profile
SectorHealth CareOpens in a new window
IndustryBiotechnologyOpens in a new window
Company LocationCambridge, MA
Seres Therapeutics, Inc., a microbiome therapeutics company, develop microbiome therapeutics to treat the modulation of the colonic microbiome. It develops a novel class of biological drugs that are designed to treat by modulating the microbiome to restore health by repairing the function of a disrupted microbiome to a non-disease state. The company's lead product candidate is SER-109, an oral microbiome therapeutic that has completed Phase III clinical trial for the treatment of recurrent Clostridioides difficile infection. Its product pipeline also includes SER-155, an investigational oral fermented microbiome therapeutic which is in Phase 1b clinical trials for the treatment of gastrointestinal infections, bacteremia, and graft versus host disease in immunocompromised patients including patients receiving allogeneic hematopoietic stem cell transplantation. In addition, the company engages in the development of SER-287 which is in Phase 2b and SER-301 that is in Phase 1b to treat ulcerative colitis. Further, it has license Agreement with NHSc Rx License GmbH for the therapeutic products based on the microbiome technology, which includes SER-109 product candidate, which is developed for the treatment of CDI and recurrent CDI; collaboration license agreement with Societe des Produits Nestle S.A. (Nestle) for the development and commercialization of certain product candidates for the treatment and management of CDI and inflammatory bowel disease including UC and Crohn's disease; research collaboration and option agreement with AstraZeneca Inc. for research and develop of microbiome in certain cancers and cancer immunotherapies, including research program for SER-401 targeting various cancers. The company was formerly known as Seres Health, Inc. and changed its name to Seres Therapeutics, Inc. in May 2015. Seres Therapeutics, Inc. was incorporated in 2010 and is headquartered in Cambridge, Massachusetts.
www.serestherapeutics.com
0

[MiamiGent]

MCRB countdown to tomorrow's PDUFA. Have you loaded?

https://stockcharts.com/h-sc/ui?s=MCRB

MG

[MiamiGent]

MCRB Wednesday PDUFA

While we wait..

Weekend Music
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171755545

[MiamiGent]

MCRB In today for PDUFA next week.

Have a great weekend, all!

MG

[Extremist223]

=========================

[Extremist223]

No rebuttal? Is this market even worldwide? Or am I on some fake market for just my pc?

[Extremist223]

I don't know why pharma wouldn't short this POS, if they cure recurrent c. diff it's no longer recurrent and so you aren't selling anything. Doesn't seem like the business model works at all.

It's like sellin' food with vitamins still in it when your competitors did a manual extraction and started selling a separate line of vitamin pills.

It's recurrent for a reason!

[swingingRichard]

I'm not saying I would have played it, but using this chart, I'm not all that surprised by the huge move. It's all about the forced state transition bands.

[crudeoil24]

MCRB is a great $$$$$ opportunity.

[crudeoil24]

Current shelf placement closes Monday, and generates over $200M .
Plus we have a huge new life saving drug coming to marketplace.

[ClayTrader]

* * $MCRB Video Chart 08-13-2020 * *

Link to Video - click here to watch the technical chart video

[ClayTrader]

* * $MCRB Video Chart 08-10-2020 * *

Link to Video - click here to watch the technical chart video

[davidsson10]

MCRB Asset Accumulation

[rlangmaid]

This is HUGE... I am an NP so I know!!

[CyrusDaVirus]

Whats the price target here? Yes

[chuckgray]

73k CDI episodes of 2+ recurrences/year in US as studied in current study. Another 100k/year primary recurrence cases being studied in open label extension trial. Will SER-109 eventually be studied and used for the other 439k/year CDI patients in US to prevent any recurrences?