BPC April 22 update

2Q Earnings + near term catalysts; Biotech week in review

Weekly watchlist

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With the earnings season underway, we turn our focus to key companies reporting next week. The majority of biotech and pharmaceutical companies covered by BioPharmCatalyst are in the clinical trial phase of drug development and have little revenue, so one normally sees little share price impact from earnings reports. However, for large-cap companies that are fortunate to have drugs on the market, earnings season presents a major catalyst.

First, let’s review the week that was with notable price-moving events in the healthcare sector.

REGULATORY

Ampio Pharmaceuticals Inc (NYSE: AMPE) received a written response from the FDA pursuant to a Type C meeting request regarding the AP-013 Phase 3 trial results. The FDA did not agree that AP-013 could serve as a second pivotal trial based on the change in the analysis population and pain only instead of the original prespecified co-primary endpoints. Shares closed the week down 28% at $0.28.

Petros Pharmaceuticals, Inc. (NASDAQ: PTPI) released results from an over-the-counter label comprehension study for STENDRA (avanafil) to treat erectile dysfunction (ED). The study demonstrated that the language was appropriate and will be submitted to the FDA for approval. Shares closed the week up 14% at $1.36.

TG Therapeutics, Inc. (NASDAQ: TGTX) announced that it voluntarily withdrew its Biologics License Application (BLA) and supplemental New Drug Application (sNDA) for ublituximab and UKONIQ (umbralisib) to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Shares closed the week up 18% at $7.13.

CLINICAL

Windtree Therapeutics Inc (NASDAQ: WINT) announced primary results for SEISMiC, a Phase 2 study with istaroxime to treat patients with early cardiogenic shock due to severe heart failure with systolic blood pressures (SBP). The study met its primary endpoint in rapidly raising SBP profile over six hours. Shares closed the week down 21% at $0.81.

Clarus Therapeutics Holdings Inc. (NASDAQ: CRXT) shares closed up 43% at $2.08 after the company announced it would present new data for Jatenzo on April 23, 2022, at the Androgen Society's annual meeting. Shares closed the week up 49% at $1.80.

OTHER

Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) announced that it would be acquired by Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) for $10.50 per share, totalling an equity value of approximately $250 million. Shares closed the week up 316% at $10.39.

Diffusion Pharmaceuticals Inc (NASDAQ: DFFN) announced a 1-for-50 reverse stock split of its stock effective at the market's opening on April 19, 2022. Shares closed down 34% at $0.17. Shares closed the week down 31% at $7.33.

Cassava Sciences, Inc. (NASDAQ: SAVA) shares are trading down in the premarket after the New York Times released an article covering the retractions of data from studies related to its drug simufilam, to treat Alzheimer disease. Shares closed the week down 27% at $19.01.

Vallon Pharmaceuticals Inc. (NASDAQ: VLON) announced that it has engaged Ladenburg Thalmann & Co Inc to evaluate strategic alternatives for the Company to maximize shareholder value. Ladenburg will advise Vallon on the strategic review process, including exploring the potential for a possible merger, business combination, investment into the Company, purchase, license, or other acquisition of assets. Shares closed up 101% at $2.27. Shares closed the week up 68% at $2.27.

SCYNEXIS, Inc. (NASDAQ: SCYX) announced a public offering of common stock. The gross offering proceeds to this offering are expected to be approximately $45.0 million, before deductions. Additionally, Scynexis announced interim data from its Phase 3 FURI and CARES studies, results were consistent with previously reported data and support continued patient enrollment in both studies. Shares closed the week down 30% at $2.33.

EARNINGS:

Selection of top revenue-earning companies scheduled to report earnings week of April 25th- April 29th (PREMIUM members see BioPharmCatalyst earnings calendar for full list and details).

MONDAY: PHG

TUESDAY: GE NVS MMM CAJ

WEDNESDAY: AMGN

THURSDAY: MRK SNY TMO LLY GILD

FRIDAY: ABBV BMY

Drug Price Stage Catalyst Market Cap

AXSM – Axsome Therapeutics Inc.
MoSEIC meloxicam-rizatriptan (AXS-07)
Migraine

$31.65
+0.14  +0%
CRL CRL announced May 2, 2022.
$1.2 billion

BMY – Bristol-Myers Squibb Company
Camzyos (mavacamten)
Hypertrophic cardiomyopathy (HCM)

$76.19
+0.23  +0%
Approved Approved April 28, 2022.
$162.2 billion

HGEN – Humanigen Inc.
Lenzilumab - (ACTIV-5/BET-B)
COVID-19

$2.26
+0.02  +1%
Phase 2/3 Phase 2/3 target enrollment achieved, noted January 5, 2022. Phase 2/3 top-line data due in 2Q 2022. If successful data can be used for EUA submission.
$159.6 million

MGTA – Magenta Therapeutics Inc.
MGTA-145 and plerixafor
Multiple Myeloma

$1.22
-0.24  -16%
Phase 2 Phase 2 investigator-initiated clinical trial data confirmed previously reported positive topline clinical data where it achieved the primary endpoint for collection of hematopoietic stem cells (HSCs), was well-tolerated and mobilized HSCs which were able to successfully engraft with positive 100-day outcomes, noted December 14, 2021.
$71.7 million

MREO – Mereo BioPharma Group plc
Alvelestat - (ASTRAEUS)
Severe alpha-1 antitrypsin deficiency

$0.53
+0.04  +9%
Phase 2 Phase 2 study have shown good safety to-date and the study has now recruited 99 patients and per protocol, enrollment has been biased towards the high dose, noted December 27, 2021. Phase 2 study demonstrated to be statistically significant inhibition of blood neutrophil elastase activity of up to 90% in patients in both high and low dose groups throughout the 12-week dosing period, noted May 9, 2022.
$62.3 million

PHAT – Phathom Pharmaceuticals Inc.
VOQUEZNA
H. pylori

$8.67
+0.16  +2%
Approved Approval announced May 3, 2022.
$338.8 million

TARS – Tarsus Pharmaceuticals Inc.
TP-03 - (Saturn-2)
Demodex Blepharitis

$13.70
+0.29  +2%
Phase 3 Phase 3 top-line data reported that 56% of patients on TP-03 achieved the primary endpoint, noted May 2, 2022. NDA filing due in 2H 2022.
$360.7 million