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Thursday, August 8, 2024

Altimmune Q2 update

 Recent presentations at major medical meetings provide further support for the differentiated profile of pemvidutide in obesity and metabolic dysfunction-associated steatohepatitis (MASH)

Enrollment progressing in Phase 2b IMPACT trial of pemvidutide in MASH with topline data expected in Q1 2025

Cash, cash equivalents and short-term investments of $164.9 million on June 30, 2024

Webcast to be held today, August 8, 2024, at 8:30 am ET

Conference Call Information:
   
Date: Thursday, August 8, 2024
Time:  8:30 am Eastern Time
Webcast: To listen, the conference call will be webcast live on Altimmune’s Investor Relations
website at https://ir.altimmune.com/investors.
Dial-in: To participate or dial-in, register here to receive the dial-in numbers and unique PIN to
access the call.
 

Following the conclusion of the call, the webcast will be available for replay on the Investor Relations (IR) page of the Company’s website at www.altimmune.com. The Company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

https://www.globenewswire.com/news-release/2024/08/08/2926756/0/en/Altimmune-Announces-Second-Quarter-2024-Financial-Results-and-Provides-a-Business-Update.html

Harris/Walz Rally Was Really Just Another Free Concert

 by Steve Watson via Modernity.news,

Kamala Harris’ campaign has once again used a free concert as a way of drawing people to their rally for the photo op.

A large number of people turned up at an outdoor stadium Eau Claire, Wisconsin on Wednesday, yet most appeared to be there to watch Grammy award-winning indie folk band Bon Iver.

The lead singer of the band, Justin Vernon, is from Eau Claire.

NPR reported that “Vice President Harris will draw from some hometown talent on Wednesday when Bon Iver performs at a rally in Eau Claire, Wis. — part of a barnstorm tour of swing states she is doing with her running mate this week.”

Observers note that there was a distinct lack of Harris/Walz signs, and a lot of middle aged beardy folk men in the crowd.

As we highlighted last week, this happened in Atlanta, where the large crowd turned up to watch rapper Megan Thee Stallion and some dancers shake their asses around, then started walking out when Harris took the stage.

The campaign is desperately attempting to use popular culture and influencers to gain traction.

For example, wildly popular Twitch streamer Kai Cenat, who has over 12 million followers told his viewers that he had been approached by Harris’ people about doing a livestream with her, but noted only Cenat has no interest in doing it.

Cenat declared “Kamala is getting rejected by everyone,” noting that the campaign reached out five times to try to get him on board but he doesn’t “give a fuck” about her.

In addition, State Senator Jake Hoffman of Arizona received information from an influencer showing that the Harris campaign has been paying social media influencers in an effort to boost popularity.

Hoffman charged that the campaign is engaged in astroturfing, and has “zero grassroots, so they’re trying to manufacture fake support using cash as the incentive.”

The letter from Alicia Howard of the Harris-Walz campaign reads “if you’re interested in creating content on Instagram, please let me know as soon as possible. We can discuss the details and compensation for your involvement.” The campaign then sent a follow-up note promising “paid partnership.”

It appears the campaign is also employing marketing groups to reach out to influencers with promises of cash for content.

Meanwhile, Donald Trump took part in a huge live stream with influencer Adin Ross Monday, attracting over 580,000 live viewers and reportedly over 100 million subsequent views.

Next week Trump is scheduled to take part in a conversation with Elon Musk.

*  *  *

https://www.zerohedge.com/political/harriswalz-rally-was-really-just-another-free-concert

For The First Time, F-16 Fighter Jets Spotted In Combat Over Ukraine

 A Russian official in Ukraine's Kherson region has reported that a US-supplied F-16 fighter jet has been seen flying over the southern Ukrainian territory which lies just north of Crimea. This marks a first sighting in Ukrainian skies, after this past weekend President Zelensky confirmed the arrival of the initial batch of the jet fighters from European partners.

Pavel Filipchuk, the head of the administration of the Kakhovka municipal district in the Kherson Region, posted to Telegram Thursday the following message: "F-16s have been flying over our district since yesterday." No verified video of the flights over the region have emerged just yet, however.

Illustrative: Ukrainian presidency's office

The Russian official followed by expressed confidence that "they will be shot down and destroyed soon,according to state-run Sputnik

"F-16s in Ukraine. We did it," President Zelensky said at a Sunday ceremony from an unnamed airbase, allowing reporters to view two of the parked aircraft. The Economist later indicated that ten have so far been delivered, out of a pledged total of 79.

Russia's reaction has been to vow that the jets will be destroyed just like the US and European-supplied tanks from earlier in the conflict:

Kremlin press secretary Dmitry Peskov previously vowed that Western-made F-16s flying for Ukraine would be "shot down".

"But of course, these deliveries will not have any significant impact on the development of events on the front," he added.

The consensus among even Western mainstream media is that the F-16s will not be a game-changer. Additionally, Zelensky is already pressing Washington and its allies for more.

Prior statements of US defense officials confirmed that the Pentagon is equipping the F-16s with advanced weaponry and modern missiles.

As the The Wall Street Journal previously indicated, this will include air-to-ground AGM-88 HARM missiles, bomb sights, diameter bombs, AMRAAM advanced air-to-air missiles, and AIM-9X short-range air-to-air missiles.

https://www.zerohedge.com/geopolitical/f-16-fighter-jets-spotted-over-southern-ukraine-first

Amicus ups revenue guidance

 Q2 2024 Total Revenue of $126.7M, a 34% Increase Year-over-Year

Galafold® Q2 Revenue of $110.8M, up 17% Year-over-Year

Pombiliti® + Opfolda® Q2 Revenue of $15.9M, up 44% from Q1 2024

Raising 2024 Total Revenue Growth Guidance to 26%-31% at CER and 2024 Galafold Growth Guidance to 14%-18% at CER

Narrowing non-GAAP Operating Expense Guidance to $345M to $360M

Non-GAAP Profitability Achieved in Q2 and H1 2024 with Acceleration Expected in H2

Conference Call and Webcast Today at 8:30 a.m. ET

Conference Call and Webcast

Amicus Therapeutics will host a conference call and audio webcast today, August 8, 2024, at 8:30 a.m. ET to discuss the second quarter 2024 financial results and corporate updates. Participants and investors interested in accessing the call by phone will need to register using the online registration form. After registering, all phone participants will receive a dial-in number along with a PIN number to access the event.

A live audio webcast and related presentation materials can also be accessed via the Investors section of the Amicus Therapeutics corporate website at ir.amicusrx.com. Web participants are encouraged to register on the website 15 minutes prior to the start of the call. An archived webcast and accompanying slides will be available on the Company's website shortly after the conclusion of the live event.

https://www.globenewswire.com/news-release/2024/08/08/2926804/15991/en/Amicus-Therapeutics-Announces-Second-Quarter-2024-Financial-Results-and-Corporate-Updates.html

Ironwood cuts guidance

 – LINZESS® (linaclotide) EUTRx prescription demand growth of 11% year-over-year –

– Plans to pursue apraglutide rolling NDA review; expects to complete submission in the first quarter of 2025 –

– On track to deliver CNP-104 topline results in the third quarter of 2024 –

– Revises FY 2024 financial guidance due to continued LINZESS pricing pressure associated with higher-than-expected Medicaid utilization trends –

https://www.businesswire.com/news/home/20240808744786/en/

Axogen ups guidance

 

  • Second quarter revenue was $47.9 million, a 25.6% increase compared to the second quarter of 2023.
  • In the second quarter of 2024, our gross margin decreased to 73.8%, down from 77.7% in the second quarter of 2023.
  • Net loss for the quarter was $1.9 million, or $0.04 per share, compared to net loss of $6.7 million, or $0.16 per share in the second quarter of 2023.
  • Adjusted net income for the quarter was $2.0 million, or $0.05 per share, compared to adjusted net loss of $1.3 million, or $0.03 per share in the second quarter of 2023.
  • Adjusted EBITDA was $5.6 million for the quarter, compared to an adjusted EBITDA loss of $0.2 million in the second quarter of 2023.
  • The balance of all cash, cash equivalents, and investments on June 30, 2024, was $27.1 million, as compared to a balance of $23.6 million on March 31, 2024.

2024 Financial Guidance

We are increasing our annual revenue guidance to the range of $182 million to $186 million. We are also adjusting our gross margin guidance for the full year to be in the range of 74% to 76%. Additionally, we reiterate that we expect to be net cash flow positive cumulatively for the period from April 1st through year end.

Conference Call

The Company will host a conference call and webcast for the investment community today at 8:00 a.m. ET. Investors interested in participating in the conference call by phone may do so by dialing toll free at (877) 407-0993 or use the direct dial-in number at (201) 689-8795. Those interested in listening to the conference call live via the Internet may do so by visiting the Investors page of the Company's website at www.axogeninc.com and clicking on the webcast link.

Following the conference call, a replay will be available in the Investors section of the Company's website at www.axogeninc.com under Investors.

https://www.globenewswire.com/news-release/2024/08/08/2926774/0/en/Axogen-Inc-Reports-Second-Quarter-2024-Financial-Results.html

Sobi, Apellis positive topline in phase 3 kidney disease trial

 

  • Met the primary endpoint, achieving statistically significant 68% (p<0.0001) reduction in proteinuria compared to placebo in a broad study population
  • Positive results consistent across all subgroups, including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneys
  • Demonstrated favourable safety, consistent with established profile
  • Companies plan to submit data for regulatory approval in the US and EU