ACER (MKap $29 M) 2x Phase 3 Assets +Covid 19 Daten im Q4 (Seite 2)

[Ineos]

Second Quarter 2023 Financial Results and Provides Corporate Update

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Acer Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update

OLPRUVA™ (sodium phenylbutyrate) kits now available in all dosage strengths and ready to ship to patients

NEWTON, MA – August 14, 2023 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious, rare and life-threatening diseases with significant unmet medical needs, today reported financial results for the second quarter ended June 30, 2023 and provided a corporate update.

“The second quarter of 2023 marked continued progress for Acer as we execute on our OLPRUVA™ launch strategy,” said Chris Schelling, CEO and Founder of Acer. “We are pleased to offer OLPRUVA™ in the U.S. to certain UCD patients as a novel alternative option to current treatments that was specifically designed for palatability and convenience.1,2 With OLPRUVA™ kits now available in all dosage strengths, we are committed to supporting patients from initial prescription to support throughout the treatment process and look forward to making OLPRUVA™ available to patients in need.”

Program and Corporate Highlights

OLPRUVA™ (sodium phenylbutyrate) for oral suspension
OLPRUVA™ kits are now available in all dosage strengths and ready to ship to patients
A dedicated OLPRUVA™ Navigator Team at CVS Specialty is now available to provide prescription fulfillment support throughout the treatment process; healthcare provider and patient resources are also now available at www.OLPRUVAHCP.com and www.OLPRUVA.com
Acer Therapeutics is in discussions with both commercial and government payers and is actively engaged with the major pharmacy benefits managers (PBM) and group purchasing organizations (GPO) representing a substantial majority of covered lives
Corporate
Ended Q2 2023 with $1.6 million in cash and cash equivalents. Acer believes its cash and cash equivalents available as of June 30, 2023 will be sufficient to fund its anticipated operating and capital requirements through mid-Q3 2023

Anticipated Milestones (Subject to Available Capital)

Q3 2023: Acer expects to begin attaining OLPRUVA™ commercial insurance coverage in Q3 2023
Q3 2023: Acer expects to begin attaining insurance coverage for OLPRUVA™ Medicaid patients starting in Q3 2023
H1 2024: Acer anticipates enrollment completion in H1 2024 of its pivotal Phase 3 DiSCOVER trial of EDSIVO™ in patients with COL3A1-positive vEDS
Acer also intends to pursue additional opportunities for potential OLPRUVA™ label expansion, including the potential for additional dosage strengths to address patients with lower weights/body surface areas, and potential administration using a gastrostomy tube (G-tube)

Q2 2023 Financial Results

Cash Position. Cash and cash equivalents were $1.6 million as of June 30, 2023, compared to $2.3 million as of December 31, 2022. Acer believes its cash and cash equivalents at June 30, 2023 will be sufficient to fund its anticipated operating and capital requirements through the middle of the third quarter of 2023.

Research and Development Expenses. Research and development expenses were $1.4 million, net of collaboration funding of $0.6 million, for the three months ended June 30, 2023, as compared to $3.4 million, net of collaboration funding of $1.6 million, for the three months ended June 30, 2022. This decrease of $2.0 million was primarily due to decreases in expenses for clinical studies, employee-related expenses, expenses for consulting and professional services, and contract manufacturing expenses. Research and development expenses related to ACER-001 decreased in the three months ended June 30, 2023, resulting in a decrease in the recognition of the collaboration funding from the Collaboration Agreement with Relief. Research and development expenses for the three months ended June 30, 2023 were comprised of $1.0 million related to EDSIVOTM; $0.6 million related to ACER-001, offset by $0.6 million of collaboration funding; $0.2 million related to ACER-801; and $0.2 million related to other development activities.

General and Administrative Expenses. General and administrative expenses were $2.9 million, net of collaboration funding of $1.4 million, for the three months ended June 30, 2023, as compared to $3.6 million, net of collaboration funding of $3.3 million, for the three months ended June 30, 2022. This decrease of $0.7 million was primarily due to decreases in marketing expenses, expenses for consulting and professional services, and employee-related expenses. General and administrative expenses related to ACER-001 decreased in the three months ended June 30, 2023, resulting in a decrease in the recognition of the collaboration funding from the Collaboration Agreement with Relief.

Net Loss. Net loss for the three months ended June 30, 2023 was $8.1 million, or $0.33 net loss per share (basic and diluted), compared to a net loss of $2.7 million, or $0.17 net loss per share (basic and diluted), for the three months ended June 30, 2022.
For additional information, please see Acer’s Quarterly Report on Form 10-Q filed today with the Securities and Exchange Commission (SEC).

About Acer Therapeutics
Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. In the U.S., OLPRUVA™ (sodium phenylbutyrate) is approved for the treatment of UCDs involving deficiencies of CPS, OTC, or AS. Acer is also advancing a pipeline of investigational product candidates for rare and life-threatening diseases, including: OLPRUVA™ (sodium phenylbutyrate) for treatment of various disorders, including Maple Syrup Urine Disease (MSUD); and EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation. For more information, visit www.acertx.com.

References

OLPRUVA™ (sodium phenylbutyrate) for oral suspension. Prescribing information. Newton, MA: Acer Therapeutics Inc.
Appel LE, Shockey JR, Schelling DC, inventors; Acer Therapeutics Inc, assignee. Palatable compositions including sodium phenylbutyrate and uses thereof. US patent 11,154,521 (B2). October 26, 2021.


Acer Forward-Looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. Examples of such statements include, but are not limited to, statements about plans and strategy for the commercialization of OLPRUVA™ for oral suspension in the U.S. for the treatment of certain patients with certain UCDs, including progress with respect to discussions with commercial and government insurance providers, physicians outreach and awareness, and patient support and fulfillment, statements with respect to our EDSIVO clinical trial for patients with vEDS, including enrollment and timing milestones related thereto, statements about our anticipated 2023 milestones, statements about our investment of OLPRUVA revenue, and statements about our capital requirements and sufficiency and duration of our current cash and cash equivalents. Our efforts to commercialize OLPRUVA™ for oral suspension in the U.S. for the treatment of certain patients with UCDs involving deficiencies of CPS, OTC, or AS are at an early stage, we currently do not have fully developed marketing, sales or distribution capabilities, and there is no guarantee that we will be successful in our commercialization efforts. Our pipeline products (including OLPRUVA™ for indications other than UCDs as well as EDSIVO™ and ACER-801) are under investigation and their safety and efficacy have not been established and there is no guarantee that any of our investigational products in development will receive health authority approval or become commercially available for the uses being investigated. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the availability of financing to fund our commercialization efforts, our pipeline product development programs and our general corporate operations as well as risks related to drug development and the regulatory approval process, including the timing and requirements of regulatory actions. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. You may access these documents for no charge at http://www.sec.gov.





Corporate and IR Contacts
Jim DeNike
Acer Therapeutics Inc.
[e-mail]
[phone]

Nick Colangelo
Gilmartin Group
[e-mail]
[phone]
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Copyright © Acer Therapeutics, Inc., 2023, All rights reserved.

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[Freudivestor]

Antwort auf Beitrag Nr.: 74.271.507 von Trendbewerter am 07.08.23 09:47:07

Relief ist eine glaubwürdige Quelle (zu dem Thema würde ich mal das Relief Forum genauer anschauen)? Und Relief ist besser informiert als Acer selbst?
Oder sollte der kommerzielle Launch von Olpruva Acer etwa nicht eine Nachricht wert sein? Würde dem Kurs ja wohl nur gut tun und daher im eigenen Interesse liegen.
Auf der HP von Acer findet man jedenfalls nichts dazu. Der Launch wird in der Präsentation von Acer immer unter Vorbehalt der Verfügbarkeit zusätzlicher finanzieller Mittel beschrieben - die 1 Mio vom CEO zählt explizit nicht dazu. Sonst gibt es keinen veröffentlichten Hinweis auf zusätzlich erhaltene Finanzierungen.
Ich würd mir sehr wünschen dass Olpruva tatsächlich schon gelauncht wurde und kommerziell verfügbar ist, ich bin auch in Acer investiert, aber bis jetzt seh ich keine harten Fakten dass Olpruva tatsächlich am Markt erhältlich ist.

[Trendbewerter]

Fundstelle ist die aktuelle Relief Th Corporate Präsentation aus August 2023

https://relieftherapeutics.com/images/pdf/Relief-Therapeutic…
Seite 3

[Trendbewerter]

Auf Stockwits veröffentlicht Nutzer BambooPanda Milestones - danach ist Olpruva im Markt

Hallo zusammen,

Einführung Olpruva soll als ein Milestone im 3. Quartal 2023 gewesen sein. Ist ja auch stimmig.

https://stocktwits.com/BambooPanda/message/539123010

[img[/img]

Leider zitiert dieser Nutzer nicht seine Fundstelle. Scheint aber eine Fundstelle bei Acer Th. zu sein.
Es wird jedenfalls immer konkreter - finde ich persönlich.

[Gentlebee]

!

Dieser Beitrag wurde von SelfMODus moderiert. Grund: Gegen Boardregel -- 9.3.7 Veröffentlichung von Identitäten, personenbezogenen oder vertraulichen Daten und Informationen sowie Boardmails ohne Zustimmung aller involvierten Parteien.

[Trendbewerter]

Ohio natürlich.

Sorry - nicht Ohia - dafür Ohio.

[Trendbewerter]

In immer mehr Fundstellen finde ich Olpruva als verfügbares Medikament

Hallo zusammen,
ausser mir scheint es ja kaum noch jemanden im Forum zu geben, der / die mal in Sachen Olpruva Recherchen durchführt.

Seis drum.

Neben Blink Health habe ich heute unter den nachfolgenden Links jeweils Olpruva in den verfügbaren Medikamentenlisten gefunden.

02.08.2023
State of Wisconsin Group Health Insurance Program Formulary - formulary.pdf (wisconsin.edu)

Healthalliance.org – Gesundheitsversicherung /-organisation / Pharmacie für Iowa, Ohia, Illinois , Indiana und Washington - HAMPEHB_(A5-CTR) (healthalliance.org) – Olpruva eingeben und auf der Medikamentenliste auf Seite 151 findest Du OLPRUVA
Einzel-, Medicare- und Gruppenkrankenversicherung (Fundstelle : https//www.healthalliance.org)

Wie gesagt - mein Eindruck ist, dass Olpruva bereits verfügbar ist.

Allerdings die IR von ACER Th. ist grottenschlecht.
Habe Jim DeNike von Acers IR am 28.07. und heute wieder angemailt. Bis heute null Rückmeldung.

[Trendbewerter]

Kann es sein das Olpruva verfügbar ist ?

Hallo zusammen,
ich bin gerade auf der Homepage von Blink Health ( Online Pharmacie in den USA ) und da kann man bei Rezepteinreichung angeblich Olpruva erwerben.
Tagesdosis 2982 US Dollar.
Ich kann es nicht prüfen, da ich keinen Zugang habe - hat jemand hier im Forum Kontakte in die USA oder eigene Möglichkeiten ?

Ich schicke mal den Link mit - schaut selbst und bitte ruhig Hinweis geben, wenn ich zu optimistisch denke in diesem Punkt.
https://www.blinkhealth.com/olpruva

Blink Health selbst schreibt :
Akzeptiert meine Apotheke Blink? ------- Blink wird landesweit in 35.000+ Apotheken akzeptiert, darunter Walmart, Albertsons, Kroger, Publix, Costco, Safeway, HEB, Brookshires und viele mehr. Die meisten unabhängigen Apotheken akzeptieren auch Blink. Finden Sie hier eine Apotheke in Ihrer Nähe.

wie immer - keine Kauf - Verkaufempfehlung.

[jfm]

Das Pferd kann auch Tod umfallen!
Wenn RLF dabei ist weiss man nie was rauskommt… Könnte auch eine Ente sein😊

[NEW_VALUE]

Welche Wette?

Auf welches Pferd setzt man unter der Annahme es wird in Kürze offiziell der Launch von Olpruva und die Sicherstellung einer Finanzierung verkündet?

ACER Therapeutics ?
RELIEFT Therapeutics ?
... ?