BPC May 20 update

Key Phase 3 catalysts left for the quarter; Biotech week in review

Weekly watchlist

Congrats to this week’s winner RameshS! Your pick of PDSB ended the week up 18%. PDS Biotechnology Corporation is an immunotherapy company developing molecularly targeted cancer immunotherapies and infectious disease vaccines. As a biotech stock he won double the prize!

BioPharmCatalyst commenced a weekly trading competition “Stock of the Week '' on our Discord server. Enter your stock pick each week and the biggest gainer wins cash and prizes. Make your account and submit your pick here.

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This week we reanalyze our watchlist for Phase 3 events for the second quarter, and highlight the catalyst we are still awaiting. Next week we look back at our list of Phase 1 and Phase 2 catalysts expected for this quarter.

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

CLINICAL

Many biotech companies with exposure to monkeypox traded higher this week as global cases have been rising. SIGA Technologies, Inc. (NASDAQ: SIGA) shares closed the week up 74% at $12.4. GeoVax Labs, Inc. (NASDAQ: GOVX) shares closed the week up 114% at $1.39. Emergent BioSolutions Inc. (NYSE: EBS) shares closed the week up 23% at $35.33. Chimerix (NASDAQ: CMRX) shares closed the week up 21% at $2.35. NanoViricides, Inc. (NYSE: NNVC) shares closed the week up 57% at $2.6.

Immunome Inc (NASDAQ: IMNM) shares closed the week up 45% at $3.3 after it published preclinical data of its COVID-19 antibody cocktail IMM-BCP-01. In hampster models the product successfully neutralized the Omicron subvariant.

Immix Biopharma Inc (NASDAQ: IMMX) released interim data of IMX-110 in an animal study to treat Soft Tissue Sarcoma (STS) with a reported 75% survival rate vs. 0% survival for trabectedin. Shares closed the week up 54% at $2.12.

Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) shares closed the week up 49% at $0.52 after it announced that it will stop its Phase 2 INTRIM 1 trial of tilsotolimod to treat melanoma early after positive data reported a 70% lower SLN+ rate among patients treated compared to placebo.

OTHER

Evofem Biosciences, Inc. (NASDAQ: EVFM) announced an offering of 22,665,000 shares of its stock and 12,835,000 pre-funded warrants for the gross proceeds of $26.6 million. Shares closed the week down 64% at $0.41.

Endo International (NASDAQ: ENDP) began negotiations to reorganize its more than $8 billion of debt this week. Shares closed the week down 62% at $0.47.

Baudax Bio, Inc. (NASDAQ: BXRX) announced a registered direct offering of 1,646,091 shares of stock at $1.215 per share. Gross proceeds are to be $2 million. Shares closed the week down 36% at $0.76.

Selection of top revenue-earning companies scheduled to report earnings week of May 23th - May 27th (Subscribing members see BioPharmCatalyst earnings calendar for full list and details).

MONDAY: RSLS

TUESDAY: A

WEDNESDAY: PLUS EXAI

THURSDAY: EVGN MDT

Drug Price Stage Catalyst Market Cap

CANF – Can-Fite Biopharma Ltd Sponsored ADR (Israel)
Piclidenoson - (COMFORT)
Psoriasis

$0.90
-0.02  -2%
Phase 3 Phase 3 top-line data reported that trial met primary endpoint, noted June 29, 2022.
$24.5 million

CFRX – ContraFect Corporation
Exebacase - (DISRUPT)
Serious infections caused by Staph aureus including MRSA

$3.10
+0.03  +1%
Phase 3 Phase 3 interim futility analysis due in first week of July. BLA planned.
$121.9 million

EVLO – Evelo Biosciences Inc.
EDP1815 - (TACTIC-E)
COVID-19

$2.15
+0.04  +2%
Phase 2/3 Phase 2/3 review from Independent Data Monitoring Committee noting that the progressive mildness of the COVID-19 pandemic makes yielding a meaningful outcome for EDP1815 in TACTIC-E unlikely, noted May 12, 2022.
$232 million

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

$1.64
-0.13  -7%
Phase 2/3 Phase 2/3 target enrollment achieved, noted January 5, 2022. Phase 2/3 top-line data due in July 2022. If successful data can be used for EUA submission.
$115.8 million

NMTR – 9 Meters Biopharma Inc.
Larazotide
Celiac disease

$0.22
-0.04  -14%
Phase 3 Phase 3 interim analysis reported that the additional number of patients needed to determine a significant clinical outcome between placebo and larazotide is too large to support trial continuation, noted June 21, 2022.
$58.3 million

OPTN – OptiNose Inc.
XHANCE - (ReOpen2)
Chronic sinusitis

$3.64
-0.02  -1%
Phase 3 Phase 3 top-line data reported statistically significant benefits for both the symptoms co-primary endpoint and the CT scan co-primary endpoint, noted June 13, 2022.
$301 million

PRAX – Praxis Precision Medicines Inc.
PRAX-114 - (Aria Study; Study 213)
Major Depressive Disorder

$2.51
+0.06  +2%
Phase 2/3 Phase 2/3 data did not achieve statistical significance on the primary endpoint, noted June 6, 2022.
$114.2 million

PYPD – PolyPid Ltd.
D-PLEX100 - (SHIELD I)
Abdominal (soft tissue) sternal surgical site infections

$4.54
-0.10  -2%
Phase 3 Phase 3 enrollment completed May 31, 2022. Phase 3 topline results for 3Q 2022. Potential NDA submission targeted for 1H 2023.
$88.4 million

SWTX – SpringWorks Therapeutics Inc.
Nirogacestat (DeFi)
Desmoid tumors

$26.52
+1.90  +8%
NDA Filing Phase 3 top-line results showed statistically significant improvement in Progression-Free Survival (PFS) compared to placebo. Statistical significance was also met on all key secondary endpoints, noted May 24, 2022. NDA submission and additional data expected in 2H 2022.
$1.3 billion